Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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Dr Mohan Z Mani

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Department of Dermatolgy,
Believers Church Medical College,
Thiruvalla, Kerala
On Sep 2018




Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



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Professor and Head
Department of Pathology
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018




Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
‘Knowledge is treasure of a wise man.’ The free access of this journal provides an immense scope of learning for the both the old and the young in field of medicine and dentistry as well. The multidisciplinary nature of the journal makes it a better platform to absorb all that is being researched and developed. The publication process is systematic and professional. Online submission, publication and peer reviewing makes it a user-friendly journal.
As an experienced dentist and an academician, I proudly recommend this journal to the dental fraternity as a good quality open access platform for rapid communication of their cutting-edge research progress and discovery.
I wish JCDR a great success and I hope that journal will soar higher with the passing time."



Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




Dr. Arunava Biswas

"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
Their prompt and timely response to review's query and the manner in which they have set the reviewing process helps in extracting the best possible scientific writings for publication.
It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."



Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




Dr. C.S. Ramesh Babu
" Journal of Clinical and Diagnostic Research (JCDR) is a multi-specialty medical and dental journal publishing high quality research articles in almost all branches of medicine. The quality of printing of figures and tables is excellent and comparable to any International journal. An added advantage is nominal publication charges and monthly issue of the journal and more chances of an article being accepted for publication. Moreover being a multi-specialty journal an article concerning a particular specialty has a wider reach of readers of other related specialties also. As an author and reviewer for several years I find this Journal most suitable and highly recommend this Journal."
Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011
Anuradha

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.


Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020

Important Notice

Research Protocol
Year : 2023 | Month : March | Volume : 17 | Issue : 3 | Page : ZK13 - ZK15 Full Version

Assessment and Comparison of Sense of Coherence in Young Individuals Participating in the Treatment of their Cleft Lip and Palate Anomalies: A Prospective Interventional Study


Published: March 1, 2023 | DOI: https://doi.org/10.7860/JCDR/2023/58772.17655
Dhwani Suchak, Ranjit Kamble, Sunita Shrivastav, Jeni Mathew, Nandlal Girijalal Toshniwal

1. Postgraduate, Department of Orthodontics and Dentofacial Orthopaedics, Sharad Pawar Dental College, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India. 2. Head, Department of Orthodontics and Dentofacial Orthopaedics, Sharad Pawar Dental College, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India. 3. Professor, Department of Orthodontics and Dentofacial Orthopaedics, Sharad Pawar Dental College, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India. 4. Postgraduate, Department of Orthodontics and Dentofacial Orthopaedics, Sharad Pawar Dental College, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India. 5. Head, Department of Orthodontics and Dentofacial Orthopaedics, Rural Dental College, Pravara Institute of Medical Sciences, Loni, Maharashtra, India.

Correspondence Address :
Dhwani Suchak,
102, Department of Orthodontics and Dentofacial Orthopaedics, Sharad Pawar Dental College, Sawangi (M), Wardha, Maharashtra, India.
E-mail: dj.suchak25@gmail.com

Abstract

Introduction: Cleft lip and/or Cleft of Palate (CL/P) is amongst the most common congenital oral and maxillofacial deformities. CL/P is not thought to be harmful to one’s health. However, even if a cleft is treated early in a child’s development, there are genuine consequences, including the possibility of long-term negative health impacts such as functional and psychological issues. Antonovsky A developed a questionnaire to measure the Sense Of Coherence (SOC). It consists of three elements: comprehensibility, manageability, and meaningfulness. In patients having any kind of deviancy, SOC provides positive experiences such as increased sense of purpose, expectations, spiritual practices, respect and understanding, self-improvement and confidence, and connections have all improved.

Need of the study: Undergoing orthodontic treatment along with psychological counselling can improve the mental, emotional and social well-being of cleft lip and palate patients.

Aim: To assess changes in SOC of young patients undergoing treatment for cleft lip and palate anomalies.

Materials and Methods: The present prospective interventional study will be conducted in the Department of Orthodontics and Dentofacial Orthopaedics, Sharad Pawar Dental College, Sawangi (Meghe), Wardha, Maharashtra, India, and to be conducted on 20 patients of 14 years and below, with cleft lip and palate. Data will be gathered via questionnaires which will be distributed to patients having CL/P undergoing orthodontic treatment. The questionnaires will be collected within half an hour and will be checked, if completed. Patients will be given the same questionnaires at different points of time, i.e., at the start of the treatment, two months, six months and one year after the start of treatment. Statistical Package for the Social Sciences (SPSS) statistical software (27.0) and Graph Pad Prism will be used to analyse the data (version 7.0).

Keywords

Oral and maxillofacial deformities, Orthodontic treatment, Psychological issues

Cleft lip and palate presents with a wide array of problems and subjects the patients to a multitude of problems (1). Children with orofacial clefts may endure numerous surgical and non surgical treatments from birth until adulthood, which psychologically affects both the children and their family members (2). The CL/P is a multifaceted problem which requires a carefully planned team work to rehabilitate the patient. The disorder is presumed to be multifactorial and polygenic in its origin. Cleft lip and palate affects approximately 0.033% of the Indian population. Male population had a prevalence rate of 33.37 per 100,000 and the female population had a rate of 31.01, and all genders had a rate of 32.18. The overall number of untreated clefts in India is estimated to be 79,430, or 18.76% of the entire population (3). The presence of CL/P also affects the emotional, psychological and social well-being of the patients (4).

The concept of SOC was put forward by Antonvsky A in 1987 wherein he tried to explain why some people fall sick under stressful conditions while others cope up well. It is made up of three elements: comprehensibility, manageability, and meaningfulness (5). In patients having any kind of deviancy, SOC provides positive experiences such as increased sense of purpose, expectations, spiritual practices, respect and understanding, self-improvement and confidence, and connections have all improved. It is important to pay attention to what a patient feels and provide them with a sense of purpose of their life (6).

Young persons with CL/P frequently express decreased appearance and speech satisfaction compared to non cleft control groups, despite other research finding no difference in appearance satisfaction between cleft and non cleft groups, or even better appearance satisfaction in the former group. Self-esteem, mental health, and quality of life are just a few of the primary psychosocial functioning areas that can be affected by dissatisfaction with one’s appearance and speech. It is crucial for research to determine which groups within the CL/P community experience the lowest appearance and speech satisfaction because many psychosocial disorders mentioned in cleft research appear to be connected to worries about appearance and speech (4).

There is a paucity of studies conducted on the changes of SOC of patients undergoing orthodontic treatment for cleft lip and palate anomalies. The rationale of this study is to assess the SOC and its changes observed over time in a group of patients having cleft lip and palate and help them by providing assistance required during their orthodontic treatment along with evaluation of their psychological state of mind.

A similar study has been conducted by Kamble R et al., on the parents of patients undergoing treatment for cleft lip and palate (3). This a continuation of the previous study to assess the effects of the treatment on the social well-being, communication skills and the acceptance in the society of the patients undergoing orthodontic treatment for cleft lip and palate.

Study Objective

• To evaluate the SOC at the time of reporting after two months, six months and one year of treatment.
• To compare results of SOC at various intervals of time.
• To evaluate the psychological changes in patients after their counselling.

REVIEW OF LITERATURE

A study was conducted by Noar JH to evaluate the self-perceived problems of patients undergoing treatment for complete unilateral cleft lip and palate and their parents (7). The findings imply that the patients were happy with the treatment they had received. They stated that the efforts of the cleft palate teams had been successful, and they were generally pleased with their overall facial look and speech. However, some were unhappy with certain features of their appearance, such as their nose, lip, profile, speech, and teeth. The parents were pleased with all elements of their child’s treatment, as well as his or her appearance and speech. The parents believed that their children’s cleft had an emotional and social impact on them, as well as a negative effect on the academic performance.

Antonovsky A developed a questionnaire to measure the SOC. The SOC scale, is a 29-item semantic differential questionnaire based on Guttman’s facet theory, helps us to understand this concept. The current paper’s goal was to provide existing data from research done in 20 countries for estimating, if the scale was feasible, reliable, and valid, as well as normative data. The Cronbach alpha measure of internal consistency in 26 studies, using SOC-29 ranged from 0.82 to 0.95. The alphas of 16 SOC-13 studies range from 0.74 to 0.91. A high level of content, face, and consensual validity is indicated by the systematic procedure utilised in scale construction and the inspection of the final output by several colleagues. The limited evidence available indicates a high level of construct validity. Criterion validity is assessed by demonstrating a similarity between the SOC and assessments in four domains: a global orientation to oneself and one’s environment; stresses; health, disease, and well-being; attitudes and behaviour. Correlations were statistically significant in the great majority of cases. The known groups technique is used to present all available published normative data on SOC-29 and SOC-13 (5).

Ramstad T et al., conducted a study on 233 Norwegian adults ageing between 20-35 years, who had completed their treatment for CL/P; of which 45 had cleft on the right, 126 had cleft on the left and 62 had cleft bilaterally (8). The Oslo cleft palate team provided standardised care to all subjects. The questionnaire-based survey reflected a nationwide study of socio-economic lifestyles in the Norwegian population. Adult patients with complete clefts were studied in comparison to a large age-matched control group. The goal of the present study was to describe the occurrence of common psychological problems in CL/P patients.

A study was conducted on people with cleft lip or cleft lip and palate to assess their judgment patterns and coping methods to find its impact on the psychological well-being and social anxiety with the help of a questionnaire by Cochrane VM and Slade P (1999) (9). The effects of the cleft were investigated on the basis of perceptions of consequences on individual and interpersonal aspects, as well as measurements of SOC, psychological well-being, levels of happiness, and how they coped in tough situations. The results were varied and there were a small number of individuals with remarkably extreme responses. A 75% of the individuals reported problems they believed to be due to their cleft. Positive responses were linked to happiness. Coping strategy patterns were linked to emotional adjustment thus concluding that individual assessments of patients with CL/P and facial appearance may be more important in determining emotional well-being of the patients.

Kamble R et al., carried out a study to evaluate the SOC in parents of the patients, undergoing treatment of CL/P (3). A questionnaire 14was distributed at time intervals of T0, T1, and T2 on 50 parents of children with CL/P. Most of the parameters were found to be statistically significant (p-value <0.05). From T0 to T1, the subjective outcomes were determined to be non significant. It was concluded that orthodontic treatment had a good impact on the parents of patients with CL/P too. It was discovered that the parents’ psychological, financial, emotional, and social well-being was affected positively.

According to Rajan AM and John R, parental resilience is receiving more attention, as a strategy for addressing their innate abilities to endure the possible pressure, that comes with raising a kid with an intellectual handicap (6). Applications for fostering their resilience can be found in understanding its basic causes. The current study investigated the relationship between parents’ resilience and the effects of children disability. A total of 121 parents in all, were evaluated using the Connor Davidson Resilience Scale and Disability Impact Scale of the National Institute for the Mentally Handicapped. The findings of his study showed that, they encountered both good and bad experiences while parenting a child with an intellectual handicap. Their assessments of the child’s health had a big impact, on how resilient they were.

According to Sousa AD et al., rehabilitation and development of patients with cleft lip and cleft palate are impacted by social and vocational concerns (10). However, psychological issues like low self-esteem and trouble interacting with others have also been observed in them.

Material and Methods

This prospective intervention study will be conducted in the Department of Orthodontics and Dentofacial Orthopaedics, Sharad Pawar Dental College, Sawangi (Meghe), Wardha, Maharashtra, India. The duration of the study will be two years. The study has been approved by the Institutional Ethics Committee (IEC) of Datta Meghe Institute of Medical Sciences, Deemed to be University with reference number DMIMS(DU)/IEC/2022/743.

Inclusion criteria:

• Patients having cleft lip and palate.
• Patients of over 14 years of age coming to the Outpatient Department (OPD).

Exclusion criteria:

• Patients below 14 years of age.
• Patients with syndromes affecting their Intelligence Quotient (IQ)
• Patients who have undergone revision surgeries.
• Daily wage workers, since they earn on a daily basis and the time invested during the study may have an impact on their day to day lives and their economical conditions.

Sample size calculation: The calculated sample size of 20 patients having cleft lip and palate undergoing orthodontic treatment will be selected for the study. Daniel formula for sample size estimation (11):

where,
Zα/2 is the level of significance at 5% i.e., 95%
Confidence interval=1.96
P=Prevalence of cleft lip and palate=1.11%=0.011 (3)
d=desired error of margin=5%=0.05

n=1.962×0.011×(1-0.011)/ 0.052
=16.86
n=20 patients needed in the study.

Study Procedure

Data will be gathered via questionnaires which will be distributed to patients. The questionnaires will be collected within 30 minutes and will be checked, if completed. Same questionnaires will be distributed to the patients at different points of time during the course of their treatment.

The SOC questionnaire was modified (3) according to the sample selected in English and modified into the regional language i.e., Marathi and Hindi. The questionnaire consisted of six parts. First part consists of demographic details the second part is subjective questionnaire. The third part is assessment of SOC using short version of SOC-13 (Antonovsky A, 1993) (5). Negatively worded items will be reverse scored, so a high score indicated a strong SOC. The fourth part is patient’s subjective experience with family. The fifth part will be family impact questions. The sixth part is regarding receipt of support from hospital staff during treatment. The validity and reliability scores of the questionnaire will be calculated after a pilot study [Annexure-1].

The questionnaire is a modified version of the questionnaire devised by Antonovsky A (12). A similar questionnaire was used in the previous study by Kamble R et al., (3). With the reference of the article published by Antonovsky A (1993) (5), the time intervals selected were:

• T0- At the time of reporting
• T1- After two months of treatment
• T2- After six months of treatment
• T3- After one year of treatment

The patients will be referred to the Department of Psychology for monthly counselling sessions and the psychological changes will then be assessed by the same questionnaires, which will be collected at different points of time. The questions will be scored and the total scores will be assessed.

Primary outcome: Undergoing orthodontic treatment along with psychologic counselling might have a positive impact on the patients undergoing treatment for cleft lip and palate.

Statistical Analysis

The SPSS statistical software (27.0) and Graph Pad Prism will be used to analyse the data (version 7.0). All descriptive and inferential data will be subjected to statistical analysis using the Chi-square test.

References

1.
Mallick R, Pisulkar SK, Reddy SG. Assessment of outcomes of immediately loaded dental implants in orofacial cleft patients: Protocol for a single-arm clinical trial. JMIR Res Protoc. 2021;10(5):e25244. [crossref] [PubMed]
2.
Al-Namankany A, Alhubaishi A. Effects of cleft lip and palate on children’s psychological health: A systematic review. J Taibah Univ Med Sci. 2018;13(4):311-18. [crossref] [PubMed]
3.
Kamble R, Shrivastav S, Sangtani J, Ahuja M, Bidwai P, Murarka S. Assessment of change in SOC of parents participating in the treatment of their children having cleft lip & palate anomalies. Journal of Evolution of Medical and Dental Sciences. 2020;9:2447-51. [crossref]
4.
Kelly SN, Shearer J. Appearance and speech satisfaction and their associations with psychosocial difficulties among young people with cleft lip and/or palate. Cleft Palate Craniofac J. 2020;57(8):1008-17. [crossref] [PubMed]
5.
Antonovsky A. The structure and properties of the sense of coherence scale. Social Science & Medicine. 1993;36(6):725-33. [crossref] [PubMed]
6.
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DOI and Others

DOI: 10.7860/JCDR/2023/58772.17655

Date of Submission: Jun 30, 2022
Date of Peer Review: Aug 02, 2022
Date of Acceptance: Dec 10, 2022
Date of Publishing: Mar 01, 2023

AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? Yes
• For any images presented appropriate consent has been obtained from the subjects. NA

PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Jul 01, 2022
• Manual Googling: Nov 23, 2022
• iThenticate Software: Dec 09, 2022 (21%)

ETYMOLOGY: Author Origin

JCDR is now Monthly and more widely Indexed .
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  • Index Copernicus ICV 2017: 134.54
  • Academic Search Complete Database
  • Directory of Open Access Journals (DOAJ)
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  • Google Scholar
  • HINARI Access to Research in Health Programme
  • Indian Science Abstracts (ISA)
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