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CTRI Number  CTRI/2024/04/064996 [Registered on: 01/04/2024] Trial Registered Prospectively
Last Modified On: 23/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry
Behavioral 
Study Design  Other 
Public Title of Study   Effectiveness of an Educational Intervention on the knowledge of nurses regarding the oral health of children with special healthcare needs 
Scientific Title of Study   EFFECTIVENESS OF AN EDUCATIONAL INTERVENTION ON KNOWLEDGE OF NURSES REGARDING ORAL HEALTHCARE NEEDS OF SPECIAL CHILDREN 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neil Godbole 
Designation  Post-Graduate  
Affiliation  Dr.D.Y.Patil Dental College and Hospital 
Address  Dr.D.Y.Patil Dental College and Hospital Sant Tukaram Nagar Pimpri Pune Maharashtra

Pune
MAHARASHTRA
411018
India 
Phone  9881190975  
Fax    
Email  dr.neilgodbole98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sunnypriyatham  
Designation  Assistsant Professor  
Affiliation  Dr.D.Y.Patil Dental College and Hospital 
Address  Dr.D.Y.Patil Dental College and Hospital Sant Tukaram Nagar Pimpri Pune Maharashtra

Pune
MAHARASHTRA
411018
India 
Phone  9490549454  
Fax    
Email  dr.priyatham@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sunnypriyatham  
Designation  Assistsant Professor  
Affiliation  Dr.D.Y.Patil Dental College and Hospital 
Address  Dr.D.Y.Patil Dental College and Hospital Sant Tukaram Nagar Pimpri Pune Maharashtra


MAHARASHTRA
411018
India 
Phone  9490549454  
Fax    
Email  dr.priyatham@gmail.com  
 
Source of Monetary or Material Support  
Dr.D.Y.Patil College of Nursing,Pimpri,Pune 
 
Primary Sponsor  
Name  Neil Godbole  
Address  Dr.D.Y.Patil Dental College and Hospital Sant Tukaram Nagar Pimpri Pune Maharashtra  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrJaya Aghamkar  Dr D Y Patil College of Nursing   Dr.D.Y.Patil Vidyapeeth, Sant Tukaram Nagar Pimpri Pune Maharashtra
Pune
MAHARASHTRA 
9767745077

jayabala.aghamkar@dpu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr D Y PATIL DENTAL COLLEGE AND HOSPITAL ETHICAL COMITEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Not applicable for our study as we are evaluating the knowledge and attitude of nursing graduates on oral health care needs of special health care needs children 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Educational Intervention on the oral heathcare needs of special healthcare children   Nursing graduates are made aware of various oral conditions and their identification and their systemic effects for a duration of 1 month 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Undergraduate nursing students enrolled in the Dr. D.Y. Patil College of nursing, Pune
2)Nursing students those who agree to participate in the study
 
 
ExclusionCriteria 
Details  Undergraduate nursing students enrolled in Dr.D.Y Patil College of Nursing,Pune who did not consent to participate in the study.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) To evaluate the knowledge of nurses regarding oral healthcare needs of special children prior to education intervention.
2) To evaluate the knowledge of nurses regarding oral healthcare needs of special children after education intervention.
3) To compare the knowledge of nurses regarding oral healthcare needs of special children before and after education intervention.
 
1) To evaluate the knowledge of nurses regarding oral healthcare needs of special children prior to education intervention at baseline.
2) To evaluate the knowledge of nurses regarding oral healthcare needs of special children 1 week and 1 month after education intervention.
3) To compare the knowledge of nurses regarding oral healthcare needs of special children before and after education intervention.
 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

 Brief resume of the intended work

 

 Need of the study

Children with special healthcare needs (SHCNs) consist of an expansive section of society, pertaining to children living with chronic physical, cognitive, communication and/or behavioural difficulties.1,2 According to the recent survey by WHO, more than 1 billion people (roughly 15% of the global population) are recorded as having some sort of disability or special need.3 Of these, there are an estimated 93 million children (aged 0–14) who are living with moderate or severe needs; of these, 13 million children suffer severe difficulties.3 For people aged 15 or over, around 892 million live with moderate or severe needs, with 175 million living with severe difficulties.3

According to previous studies, oral healthcare is often poor and neglected4. Also, oral health (OH) of special needs children deteriorates greatly due to frequent hospitalizations, destructive oral habits like bruxism and reduced manual dexterity for maintainance of oral hygiene. Oral health is ignored in special children, mostly because they need special care on many levels and hence, very less amount of time is dedicated to their oral healthcare needs5.

Nurses are one of the largest healthcare group that play an important role in promoting health, providing health care services as well as disseminating preventive information6. Nurses are the primary healthcare workers who have direct contact with special needs children and are responsible for managing their overall health care in various settings like hospitals, special institutions, homes and primary or community health centres.Therefore, they have the potential to greatly help promote oral health, prevent diseases and prioritize referrals to the children with special healthcare needs7. Therefore, the knowledge of nurses towards the oral healthcare needs of special children is of critical importance when it comes to ensuring their general well-being and quality of life.

 Carrigan L. Parish conducted a study among nurses, in which their self perceived awareness on the knowledge of children with special oral healthcare needs was found to be poor8. An important step in alleviating barriers to oral health care for special needs individuals is to empower nurses through education to more effectively and confidently promote oral health and assist in prevention strategies9.

There is a dearth of studies evaluating the knowledge of nurses on the oral healthcare needs of special children. There is an ardent need to conduct more educational collaborations  among nurses to promote a multidisciplinary approach towards the oral healthcare needs of special children, which is now in its nascent stage in India. The present study will be a pioneer study in evaluating the effectiveness of an educational intervention on the knowledge of nurses regarding oral healthcare needs of special children.

 

7.2 Review of literature

Review of Literature:

1.Jagan Kumar Baskaradoss (2022) conducted a cross-sectional study in Kuwait on the

association between the caregivers’ oral health literacy and the oral health of children and

youth with special healthcare needs. 214 caregivers of special needs children were given a

48-item questionnaire. The authors found out that more than half of the caregivers

perceived the child’s medical condition to be severe. About half the children had a dental

visit within the previous 6 months and 40% visits were for routine checkup. In conclusion,

this study found lower caregiver oral health care levels to be associated with higher plaque

scores for their child. The results could help in planning awareness campaigns to improve

oral health knowledge and attitude of caregivers. 10

2.Shenna Yu-En-Ho (2022) conducted a questionnaire based interventional study in

Singapore to evaluate the perceptions of nursing home staff and oral health therapists

regarding the barriers of oral care provision for elderly nursing home residents and their

perceptions towards interprofessional collaboration through the utilization of oral health

therapists (OHT) and nursing home residents(NH).The authors found out that OHTs and

NH residents reported mutually positive responses toward interprofessional collaboration.

They expressed willingness and competence but lacked regulatory and educational support.

The authors concluded that OHT’s have the potential to address the barriers faced by NH

staff, if adequately supported through policy and education. 11

3. Carrigan L.Parish(2014) conducted a survey based longitudinal study among pediatric

care co-ordinators and nursing supervisors employed by children’s Medical Services

(CMS) in Florida, USA. The authors found out that 22.3% of the participants had no

sources of oral health information, 55.1% had never attended an oral health education

course or training.41% of the nurses stated that families gave “low” or “no” priority

towards their childrens’ oral health. The authors concluded that an important step an

alleviating barriers to oral health care for special needs children is to empower nurses

through education to more effectively and confidently promote oral health and assist

prevention strategies. Heightening national awareness and prevention measures can

provide the impetus to deliver the required and deserved state of the special needs

population.8

4.Ronda R De Mattei (2012) conducted an interventional longitudinal survey based study

based on a service-learning project to eliminate barriers to oral health care for children

with special health care needs (SHCN).The school nurses distributed the medical history

and consent forms for a sample of 245 children among their parents. Each child received

an oral examination using a dental chair, dental light and disposable mouth mirror. The

school nurses, dentist and dental hygiene faculty collaborated together in this study. A

behaviour survey was also reviewed that was completed by the caregivers.The authors

found out that 73% of these special children underwent oral prophylaxis with good

behaviour, 15% demonstrated unco-operative behaviour but with the help of school nurses

and teachers, compliance was obtained. The school nurses confirmed the value of the

educational experiences. In conclusion, according to the school nurses and teachers, there

is a need for effective interventions to support the dental care for special children. This

project is an example of an effective model of a school based oral care delivery system that

can be replicated and implemented to address the oral needs of this population. 12

 

 Aim of the study:

To evaluate the effectiveness of an educational intervention on knowledge of nurses regarding oral healthcare needs of special children.

Objectives of this study:

1) To evaluate the knowledge of nurses regarding oral healthcare needs of special children prior to education intervention.

2) To evaluate the knowledge of nurses regarding oral healthcare needs of special children after education intervention.

3) To compare the knowledge of nurses regarding oral healthcare needs of special children before and after education intervention.

 

Materials and Methods

Source of data.

●       Type of study- Interventional study

 

●       In-vitro/in-vivo/survey- Survey

  

●       Source from where the cases, patients, subjects or study material will be selected- Undergraduate nursing students of Dr. D.Y. Patil College of Nursing, Pune

 

●       Name and place where the study will be conducted- Dr. D.Y Patil College of Nursing, Pune & Department of Pediatric and Preventive Dentistry.

 

 Method of data collection

●       Sampling technique used – Convenience sampling

 

●       Sample size – 60

 

●       Inclusion criteria-

1)Undergraduate nursing students enrolled in the Dr. D.Y. Patil College of nursing, Pune

      2)Nursing students those who agree to participate in the study.

·       Exclusion criteria-

1)Undergraduate nursing students enrolled in Dr.D.Y Patil College of Nursing,Pune who did not consent to participate in the study.

 

●       Step wise chronological sequence

1.     Prior to start of the study, permission will be taken from institutional scientific and ethics committee

2.     Permission from dean of nursing

3.     Questionnaire to assess the knowledge of nursing students regarding oral health needs of children with special health care needs will be developed and validated.

4.     The nursing students will be explained the purpose of the study and those who agree to participate will be included after taking written consent.

5.     Knowledge of nursing students prior to the intervention will be recorded using a prevalidated questionnaire. A knowledge score will be calculated based on the number of correct answers.

6.     The education intervention consisting of a powerpoint presentation will be done. This will be followed by a doubt clearing interactive session. Hard copies of the notes will also be provided along with the power point presentation.

7.     The knowledge of nurses post education intervention will be accessed 1 week and 1 month post intervention with the help of questionnaire.

 

 

  

Duration of the study:

 

6 months

 

 Method of data analysis.

●        Mention the statistical test/s used to analyze the data.


 

List of References

1. Howell, R.; Brimble, M. Dental health management for children with special healthcare needs. Nurs. Child. Young People 2013, 25, 19–23. [CrossRef] [PubMed]

2. Burke, P.; Montgomery, S. Siblings of Children with Disabilities. J. Learn. Disabil. 2000, 4, 227–236. [CrossRef]

3. WHO. World Report on Disability 2011. “The Way Forward: Recommendations”. 2011. Available online: https://www.ncbi.nlm. nih.gov/books/NBK304067/ (accessed on 21 March 2020).

4. Carnevale, F.A.; Rehm, R.S.; Kirk, S.; McKeever, P. What we know (and do not know) about raising children with complex continuing care needs. J. Child Health Care 2008, 12, 4–6. [CrossRef]

5. Nygård, C.; Clancy, A. Unsung heroes, flying blind-A metasynthesis of parents’ experiences of caring for children with special health-care needs at home. J. Clin. Nurs. 2018, 27, 3179–3196. [CrossRef] [PubMed]

6. Alamri H. Oral Care for Children with Special Healthcare Needs in Dentistry: A Literature Review. J Clin Med. 2022 Sep 22;11(19):5557. doi: 10.3390/jcm11195557. PMID: 36233425; PMCID: PMC9573545.

 

7. Children’s Medical Services. CMS Provider Information; 2012. Available at: http://www. cms-kids.com/providers/providers.html.

8. Parish CL, Singer R, Abel S, Metsch LR. Addressing the oral healthcare needs of special needs children: pediatric nurses’ self-perceived effectiveness. Spec Care Dentist. 2014 Mar-Apr;34(2):88-95. doi: 10.1111/scd.12035. Epub 2013 Jun 19. PMID: 24588493; PMCID: PMC9295420.

9. Musa MFC, Hassan YR, Rahman F, Jeenia FT. Provision of health and dental Care in two Middle Income Asian Countries. J Biotechnol Strateg Health Res. 2018;2(3):182–8.

 

 

 


 
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