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CTRI Number  CTRI/2021/09/036407 [Registered on: 10/09/2021] Trial Registered Prospectively
Last Modified On: 09/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Benefit of counselling and whatsApp messaging for the improvement in oral hygiene of pregnant women 
Scientific Title of Study   Effectiveness of Motivational Interviewing and Cross Platform Messaging application in improving oral health knowledge, attitude and behaviors among pregnant women- A Randomized Controlled Trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amitha basheer N 
Designation  Post Graduate 
Affiliation  Yenepoya Dental College 
Address  Department of Public Health Dentistry Yenepoya Dental College Deralakatte Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8606834934  
Fax  8242204667  
Email  aminushaneeb@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Praveen Jodalli 
Designation  Reader 
Affiliation  Yenepoya Dental College 
Address  Department of Public Health Dentistry Yenepoya Dental College Deralakatte Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  09886244093  
Fax  8242204667  
Email  praveenjodalli@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Praveen Jodalli 
Designation  Reader 
Affiliation  yenepoya dental college 
Address  Department of Public Health Dentistry Yenepoya Dental College Deralakatte Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  09886244093  
Fax  8242204667  
Email  praveenjodalli@gmail.com  
 
Source of Monetary or Material Support  
Yenepoya Medical College, Yenepoya Deemed to be University, Mangalore, Karnataka, 575018 
 
Primary Sponsor  
Name  Amitha Basheer N 
Address  Department of Public Health Dentistry Room number 3 Yenepoya Dental College Yenepoya Deemed to be University Deralakatte PO Mangalore 575018 
Type of Sponsor  Other [Self funded] 
 
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 
Praveen Jodalli  Yenepoya Medical College  Department of Obstetrics and Gynaecology Room number 14 Yenepoya Deemed to be University,Deralakate,Mangalore, Karnataka 575018
Dakshina Kannada
KARNATAKA 
09886244093
8242204667
praveenjodalli@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Yenepoya University Ethics Committe 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  pregnant women of age 18 years and more with gestational age of 8 weeks to 30 weeks  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Cross platform messaging   All participants in group I will receive WhatsApp messages on oral health care of pregnant women and children. These messages will include Importance of oral health during pregnancy Hormonal changes during pregnancy Oral health’s effect on general health Importance of primary teeth and its maintenance. Diet of the mother during pregnancy Feeding practices Dietary advices for pregnant women and children and Brushing techniques.  
Intervention  Motivational interviewing  Participants in group-II will receive a 20- minute talk based on a Motivational Interviewing approach, delivered by dentist trained in MI( Principal Investigator) The MI will include four aspects,Partnership: working together with equal input from patient and Principal investigator, respecting patient autonomy.,Acceptance: understanding the patient’s perspective and not being judgmental; ensuring that we focus on their positive health behaviors and support them with their self-efficacy to change unhealthy behaviors.,Compassion: supporting patients who may be struggling with behavior change, showing real compassion and empathy towards them,Evocation: is an attempt to explore what is important to the patient and how they would like to make a change,There will be two phases for Motivational Interviewing, First Phase- there is an attempt to establish rapport and trust and to help identify the problem of concern.The MI provider will establish rapport by talking about their oral health and child’s oral health and their goals for their own and their child’s oral health using open-ended questions and affirming positive efforts. Questions will be themed around the following topics: Eliciting commitment to change, identifying potential problems, enhancing commitment to change, and recognizing resistance to change, Second phase- It involves moving from the contemplative to the action stage.The person is asked to weigh the pros and cons of changing. To communicate with participants OARS( Open-ended questions , Affirmations,Reflective listening, Summarizing) method will be used. Open-ended questions: Using open-ended questions which facilitate a dialogue between the clinician and patient so that the patient is encouraged to speak and the clinician listens. Affirmations: Acknowledge that behavior change is difficult and promote patient self-efficacy by affirming their strengths. Reflective listening: -Listening and understanding what the patient has expressed. This can enhance the relationship between the clinician and the patient, encouraging them to continue exploring change in behaviors and supporting motivation. Summarizing: Demonstrates that the clinician has listened to the patient and provides a concise overview of what has been discussed. This may also support dealing with ambivalence.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.Those who consented to participate in the study
2. With confirmed pregnancy and aged 18 years and older( gestational age between 8 and 30 weeks)
3.Participant who possess a Smartphone at the time of allotment and familiar with the usage of Whatsapp.
4.Minimal education qualification of schooling of 7th standard.
 
 
ExclusionCriteria 
Details  1. History of smoking and alcohol consumption
2. Lack of access to participate in the second stage (follow up) of the study
3. Diseases that could prevent dental examination( eg: COVID-19)
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Oral hygiene status  One month 
 
Secondary Outcome  
Outcome  TimePoints 
knowledge, attitude and behaviour of oral health care among pregnant women   one month 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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   Phase 2 
Date of First Enrollment (India)   15/09/2021 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

STATEMENT OF THE PROBLEM

Oral health education during antenatal visits can improve knowledge and practices for oral health and infant dental care significantly in all categories of the population irrespective of educational level, occupation, and socioeconomic class. There is a need to create awareness among new mothers about correct oral hygiene methods and feeding practices for the children as early as possible so that the dental health of children is not jeopardized .To the best of our knowledge, there are no previous studies conducted to assess the effectiveness of educational intervention to improve oral health knowledge and behaviours among pregnant women using Motivational Interviewing and cross platform messaging application (WhatsApp messenger).

NEED FOR THE STUDY 

The present study is designed to assess oral health status, oral hygiene practices, and self‑perception about oral health among pregnant women and to evaluate the effectiveness of Motivational interviewing and WhatsApp® ,an ubiquitous instant messaging application for oral health education on the oral health knowledge and behaviours of pregnant women attending ante natal care. These approach to health behavior modification, already successfully applied in other fields of medicine, might be a good alternative to conventional oral health promotion. The results of the present study can be used for oral health training during pregnancy in promoting the beliefs and behaviours of pregnant women on oral health and to give more attention to oral and dental education programs is recommended during pregnancy. 

AIM AND OBJECTIVES OF THE STUDY

Aim:

 To assess effectiveness of Motivational Interviewing and cross platform messaging application (WhatsApp messenger) for oral health education on the oral health knowledge, attitude and behaviours among pregnant women attending ante natal care, Mangaluru.

Objectives:

1.     To assess the knowledge, attitude and behaviour of oral health care among pregnant women attending ante natal care, Mangaluru.

2.     To assess and compare the effectiveness of Motivational Interviewing and cross platform messaging application (WhatsApp messenger) for oral health education on the oral health knowledge, attitude and behaviours among pregnant women attending ante natal care, Mangaluru.

STUDY DESIGN

Randomized Controlled Trial

MATERIALS AND METHODS 

Materials

Disposable gloves, mouth mask, mouth mirror, explorer, periodontal probe, tweezers, cotton rolls.

Methodology

The proposed study will be conducted among 84 pregnant women of age 18 years and more with gestational age of 8 weeks to 30 weeks who are visiting OPD of Department of Obstetrics and Gynaecology, Yenepoya Medical College and Hospital, Mangaluru.

Baseline examination: Principal investigator will interview participants to assess their knowledge, attitude, and behaviour of oral health care among pregnant women. Questions for the interview  is adapted from the study conducted by Bansal K et al (2019)5

Oral hygiene status will be assessed using OHI-S index by John C. Greene and Jack R. Vermillion, 1964.   Gingival inflammation will be assessed using The Loe and Silness Gingival Index,After interview and oral examination and eligible participants will be randomly allocated to one of the 2 group using lottery method.All participants in group I (n=42) will receive WhatsApp messages on oral health care of pregnant women and children after the interview. Participants in group-II (n=42)will receive a 20- minute talk based on a Motivational Interviewing approach, delivered by dentist trained in MI( Principal Investigator)

Follow up visit (after one month of intervention)

Principal investigator will interview the participants to assess their knowledge, attitude, and behaviour of oral health care using the same questions used for baseline examination. Questions for the interview  is adapted from the study conducted by Bansal K et al   (2019)5.Oral hygiene status will be assessed using OHI-S index by John C. Greene and Jack R. Vermillion, 1964.Gingival inflammation will be assessed using The Loe and Silness Gingival Index,1963.Evaluation of effectiveness of MI and cross platform messaging application (WhatsApp messenger) will be assessed.

 The proposed study will be a Randomised Controlled Trial with the following procedural steps

Obtaining approval for the study protocol from Scientific Review Board, Yenepoya deemed to be University, Mangaluru. 

Registering in Clinical Trial Registry of India.

Obtaining approval for the study protocol from Yenepoya Ethics Committee 2, Yenepoya deemed to be University, Mangalore.

Obtaining official permission to conduct the study from Department of Obstetrics and Gynaecology, Yenepoya Medical College and Hospital, Mangaluru.

 Obtaining informed consent from the participants.

Principal investigator will interview participants to assess their knowledge, attitude, and behaviour of oral health care among pregnant women

Questions for interview  is adapted from the study conducted by Bansal K et al (2019)5

II. Procedure for intervention

     The oral examination will be done by a single examiner with the help of an assistant

The study sample will comprise of 84 pregnant women of age 18 years and more with gestational age of 8 weeks to 30 weeks to 2 groups

Group 1 (n=42): Cross platform messaging application (WhatsApp messenger)

Group 2 (n=42): Motivational Interviewing for oral health education by principal investigator

 After baseline examination, eligible participants will be randomly allocated to one of the    2 groups using lottery method.

 Oral hygiene status will be assessed using OHI-S index by John C. Greene and Jack R. Vermillion, 1964

 

Scoring criteria for Debris index

 

Score 0

No debris or stain present

Score 1

Soft debris covering not more than one third of the tooth surface, or presence of extrinsic stains without other debris regardless of surface area covered

Score 2

Soft debris covering more than one third, but not more than two thirds, of the exposed tooth surface.

Score 3

Soft debris covering more than two thirds of the exposed tooth surface

 

Scoring criteria for calculus index

 

Score 0

No calculus present

Score 1

Supragingival calculus covering not more than one third of the exposed tooth surface

Score 2

Supragingival calculus covering more than one third but not more than two thirds of the exposed tooth surface or the presence of individual flecks of subgingival calculus around the cervical portion of the tooth or both.

Score 3

Supragingival calculus covering more than two third of the exposed tooth surface or a continuous heavy band of subgingival calculus around the cervical portion of the tooth or both

 

·   Gingival inflammation will be assessed using The Loe and Silness Gingival Index.,1963

The Loe and Silness gingival index (GI) is used to assess gingival inflammation. The mesial, buccal, distal, and lingual/palatal sites of each tooth present were scored for GI as follows:

 

Score 0

Normal gingiva

Score 1

Slight change in color or slight inflammation without bleeding on probing indicating mild inflammation

Score 2

Signs of redness and edematous gingiva with bleeding on probing showing moderate inflammation

Score 3

Remarkable redness and edema with susceptibility to spontaneous bleeding demonstrating severe inflammation

 

 Face to face interview will be done to assess the knowledge, attitude and behaviour of oral health care among the participants.

Questions for the interview is adapted from the study conducted by Bansal K et al (2019)5

Questions will be translated to Kannada and Malayalam language.

One group will receive health education through motivational interviewing and second group will receive oral health education through cross platform messaging application (WhatsApp messenger)

 Follow up will be done after one month

Group –I

— All participants in group I will receive WhatsApp messages on oral health care of pregnant women and children.

— These messages will include

Importance of oral health during pregnancy

Hormonal changes during pregnancy

Oral health’s effect on general health

Importance of primary teeth and its maintenance.

Diet of the mother during pregnancy

Feeding practices

Dietary advices for pregnant women and children and

Brushing techniques.

 

 

 

 

 

Group-II

Participants in group-II will receive a 20- minute talk based on a Motivational Interviewing approach, delivered by dentist trained in MI( Principal Investigator)

           The MI will include four aspects

 Partnership: working together with equal input from patient and Principal investigator, respecting patient autonomy.

 Acceptance: understanding the patient’s perspective and not being judgmental; ensuring that we focus on their positive health behaviors and support them with their self-efficacy to change unhealthy behaviors.

Compassion: supporting patients who may be struggling with behavior change, showing real compassion and empathy towards them.

Evocation: is an attempt to explore what is important to the patient and how they would like to make a change.

There will be two phases for Motivational Interviewing

First Phase-  there is an attempt to establish rapport and trust and to help identify the problem of concern.MI provider will establish rapport by talking about their oral health and child’s oral health and their goals for their own and their child’s oral health using open-ended questions and affirming positive efforts.Questions will be themed around the following topics: Eliciting commitment to change, identifying potential problems, enhancing commitment to change, and recognizing resistance to change.

Second phase- It involves moving from the contemplative to the action stage.The person is asked to weigh the pros and cons of changing.There will be discussion of the potential obstacles to action for each action option.Working with the person focuses mainly on identifying a plan to act. Several skills and methods used to communicate effectively with patients

 To communicate with participants OARS( Open-ended questions , Affirmations  Reflective listening, Summarizing) method will be used.14

Open-ended questions: Using open-ended questions which facilitate a dialogue between the clinician and patient so that the patient is encouraged to speak and the clinician listens.

Affirmations: Acknowledge that behavior change is difficult and promote patient self-efficacy by affirming their strengths.

Reflective listening: -Listening and understanding what the patient has expressed. This can enhance the relationship between the clinician and the patient, encouraging them to continue exploring change in behaviors and supporting motivation.

Summarizing: Demonstrates that the clinician has listened to the patient and provides a concise overview of what has been discussed. This may also support dealing with ambivalence.

     On the follow up visit after one month of intervention, Principal investigator will interview the participants again to assess their knowledge, attitude, and behaviour of oral health care using the same questions used for baseline examination.

      Oral hygiene status will be assessed using OHI-S index by John C. Greene and Jack R. Vermillion, 1964

     Gingival inflammation will be assessed using The Loe and Silness Gingival Index.,1963

      Evaluation of effectiveness of MI and cross platform messaging application (WhatsApp messenger) will be assessed.

   Source of data/ sampling method:

Study setting

The study will be conducted in Department of Obstetrics and Gynaecology, Yenepoya Medical College and Hospital, Mangaluru.

      Sampling method: Simple random sampling

        After oral examination eligible participants will be randomly allocated to any of the two groups using lottery method.

The study sample comprise of  pregnant women of gestational age of 8 weeks to 30 weeks

The total sample comprises of 2 groups

                                    Group I: Cross platform messaging application (WhatsApp messenger)

                                    Group II: Motivational Interviewing for oral health education

Sampling methodSimple random sampling

Sample size (including sample size calculation)

 Sample size is calculated by using G* power software for independent sample t test.

 At 5% level of significance and 80% power with effect size of 0.575 from pooled standard deviation 5.2  from related article by Bahri N et al  the total sample size in each group is 38

Total sample size n=76

At 10% non response error rate, total sample size is 84, that is 42 samples in each group. 

             Inclusion criteria:

Those who consented to participate in the study

With confirmed pregnancy and aged 18 years and older( gestational age between 8 and 30 weeks)

 Participant who possess a Smartphone at the time of allotment and familiar with the usage of Whatsapp.

 Minimal education qualification of schooling  of 7th standard.

Exclusion criteria

 History of smoking and alcohol consumption

 Lack of access to participate in the second stage (follow up) of the study

 Diseases that could prevent dental examination( eg: COVID-19)

Statistical analysis

  For continuous variable- will be presented by Mean and Standard deviation.

  For categorical variable- will be presented by frequency and percentage.  

   Independent sample t -test will be used for comparison of two groups.   Data analysis will be done using SPSS 24.0 (Statistical Package for Social Sciences).

 



 

 
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