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
|
|
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
|
|
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.
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