FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/08/044848 [Registered on: 23/08/2022] Trial Registered Prospectively
Last Modified On: 08/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral
Other (Specify) [Stress Management Intervention]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Stress management intervention for dental undergraduate students 
Scientific Title of Study   Effectiveness of stress management intervention in modifying stress levels, stressors and coping response among dental undergraduate students - A quasi experimental study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nagashree S R 
Designation  Research Scholar 
Affiliation  Government Dental College and Research Institute, Bengaluru 
Address  Department of Public Health Dentistry Government Dental College and Research Institute Fort Bengaluru

Bangalore
KARNATAKA
560002
India 
Phone  9986376759  
Fax    
Email  nagashree.savanur@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manjunath P Puranik 
Designation  Professor and Head of the Department 
Affiliation  Government Dental College and Research Institute, Bengaluru 
Address  Department of Public Health Dentistry Government Dental College and Research Institute Fort Bengaluru

Bangalore
KARNATAKA
560002
India 
Phone  9449353812  
Fax    
Email  m_p_puranik@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nagashree S R 
Designation  Research Scholar 
Affiliation  Government Dental College and Research Institute, Bengaluru 
Address  Department of Public Health Dentistry Government Dental College and Research Institute Fort Bengaluru


KARNATAKA
560002
India 
Phone  9986376759  
Fax    
Email  nagashree.savanur@gmail.com  
 
Source of Monetary or Material Support  
Department of Public Health Dentistry Government Dental College and Research Institute Fort Bengaluru 560002 
 
Primary Sponsor  
Name  Dr Nagashree S R 
Address  Research Scholar Department of Public Health Dentistry Government Dental College and Hospital Fort Bengaluru 560002 
Type of Sponsor  Other [Self sponsored] 
 
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 
Dr Nagashree S R  Government Dental College and Research Institute  Government Dental College and Research Institute Fort Bengaluru 560002
Bangalore
KARNATAKA 
9986376759

nagashree.savanur@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Government Dental College and Research Institute, Bengaluru  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Stress 
Patients  (1) ICD-10 Condition: Z733||Stress, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Stress Management Intervention  A stress management module will be designed to help students understand the components of stress and provide opportunity for students to learn, practice, and apply stress management techniques. The stress management intervention will be a class room based group intervention programme. It will be preceded by an Orientation Lecture of two hours duration on the nature of stress and understanding of its process. The intervention will consist of 16 sessions across 4 modules consisting of; ‘Breathing training’, ‘Relaxation training’, ‘Emotion identification and management’ and ‘Training on goal setting and time management’. Each module of two hour duration will be held every week on fixed days of the week during college hours. The intervention will be carried out by the trained investigator on fixed days of the week during college hours. Reinforcement session of two hours on stress management will be held for the experimental group at the end of one year, two years and three years. 
Comparator Agent  Stress Orientation Lecture  The control group will be given an orientation session on the nature of stress and healthy coping methods. The session of two hours duration will be held during college hours. The control group will also have reinforcement sessions at the end of one year, two years and three years. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  23.00 Year(s)
Gender  Both 
Details  Students in their first year of B.D.S.
Students who are 18 years of age or above.
 
 
ExclusionCriteria 
Details  Students on medication for anxiety, depression and other psychiatric issues.
Students undergoing psychiatric counselling.
Students who are practicing meditation or Yoga or any other stress management skills on a regular basis.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Stress levels using Perceived Stress Scale,
Stressors using Dental Environment Stress Survey and Coping using Brief COPE Inventory 
6 months, 12 months, 18 months, 24months, 30 months and 36 months  
 
Secondary Outcome  
Outcome  TimePoints 
None  Not applicable 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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)   01/12/2022 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Need for the study :

Stress is anything that seriously threatens homeostasis. The actual or perceived threat to an organism is called stressor and the response to the stressor is called the stress response. Stress is an adaptive process, but severe and prolonged stress responses lead to disease. Stress is a public health problem which affects physical, mental and social wellbeing. Dental students experience higher levels of stress compared to general population. Studies in different countries point out increasing stress levels as dental student progresses through the course.   

Cross sectional studies conducted across the world have showed high stress levels among dental students. Studies done in India also exhibit high levels of perceived stress among dental undergraduate students. The main stressors were academic pressure, developing interpersonal skills, workload and fear of failing the course. Adoptive coping methods like hobbies and positive reframing were used by students to deal with stress.

Stress management methods such as creating support groups, mindfulness, meditation, deep breathing, Yoga, muscle relaxation, imparting affective skills have been attempted among dental students as well as students of other courses in different countries. These interventions were carried out in recreation rooms or sports rooms and classrooms. These studies are few and of shorter duration.            

There is a clear scarcity of literature that deals with effective management of stress, stressors and coping response among dental students in India. The present research aims to assess the effectiveness of such a stress management intervention among dental undergraduate students.

Research question:

Does a stress management intervention modify the stress, stressors and coping response among dental undergraduate students?

Hypothesis:

Population & Problem: Dental undergraduate students & Stress, stressors and coping response

Intervention: Specially designed stress management intervention in experimental group.

Comparison: Stress management orientation in control group. 

Outcome: Modification in stress levels, stressors and coping response. 

Objectives of the study 

1. To assess self perceived stress, stressors, coping response and its associated factors using Perceived Stress Scale, Dental Environment Stress Survey and Brief COPE Inventory at baseline among first year dental under-graduate students in Bengaluru. 

2. To design and implement a specially designed stress management intervention and periodic reinforcements among the experimental group and orientation session regarding stress management and periodic reinforcements among control group.

3. To evaluate the effectiveness of a stress management intervention in modifying the self perceived stress, stressors and coping response at periodic intervals of 6 months, 12 months, 18 months, 24months, 30 months and 36 months among dental under graduate students.


 
Close