| CTRI Number |
CTRI/2021/10/037125 [Registered on: 06/10/2021] Trial Registered Prospectively |
| Last Modified On: |
04/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Psychobehavioural] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of psychobehavioural interventions(Mindfulness and sleep hygiene) for sleep disturbances in under graduate medical students |
|
Scientific Title of Study
|
EFFECTIVENESS OF PSYCHOBEHAVIOURAL INTERVENTIONS FOR SLEEP DISTURBANCES IN UNDER GRADUATE MEDICAL STUDENTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Atchaya Nanth N |
| Designation |
post graduate |
| Affiliation |
sri ramachandra medical college and research institute |
| Address |
Department of Psychiatry, Sri Ramachandra Medical College And Hospital, Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9944431225 |
| Fax |
|
| Email |
dratchaya.deepak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suvarna Jyothi K |
| Designation |
Associate professor |
| Affiliation |
sri ramachandra medical college and research institute |
| Address |
DepartmentofPsychiatry, Sri Ramachandra Medical College And Hospital, Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9047492143 |
| Fax |
|
| Email |
suvarna.srmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Atchaya Nanth N |
| Designation |
post graduate |
| Affiliation |
sri ramachandra medical college and research institute |
| Address |
Department of Psychiatry, Sri Ramachandra Medical College And Hospital, Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9944431225 |
| Fax |
|
| Email |
dratchaya.deepak@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri ramachandra medical college and research institute |
|
|
Primary Sponsor
|
| Name |
Sri ramachandra medical college and research institute |
| Address |
Ladies Hostel 5, Sri Ramachandra Medical College And Hospital, Porur |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Atchaya Nanth N |
sri ramachandra medical college and research institute |
Department of Psychiatry, Sri Ramachandra Medical College And Hospital, Porur
PORUR
Chennai
TAMIL NADU |
9944431225
dratchaya.deepak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee(for Medical PG students, SRIHER(DU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Sleep disturbances |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mindfulness based therapy |
Each session will be for around 1 hour and
a total of 6 sessions will be given in 3 weeks. First session will be focused on
psychoeducating the participants about the concept of mindfulness and
explaining about doing versus being mode. Second session will be targeted on
mindfulness of the body and breath. Third session will be about body scan
meditation. Fourth session will be on Mindful movement meditation. Fifth
session will be focussed on Sounds and thoughts meditation. Sixth session will
be about Three minute breathing space meditation. |
| Comparator Agent |
Sleep hygiene education |
Will receive awareness on sleep hygiene in a regular basis. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Undergraduate medical students with poor sleep quality and willing to provide informed consent |
|
| ExclusionCriteria |
| Details |
Participants with medical conditions that is known to impact sleep, major
psychiatric disorders and unwilling to participate in the study will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the quality of sleep and severity of insomnia |
At baseline and at the end of 4 weeks and 12 weeks after providing intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the mindfulness skills |
At baseline and at the end of 4 weeks and 12 weeks after providing intervention which is
applicable to the arm receiving mindfulness therapy |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
11/10/2021 |
| 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="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response (Others) -
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 21-06-2022 and end date provided 21-07-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Purpose: To explore the effectiveness of psychobehavioural interventions in improving the quality of sleep.
Design: Open label, Randomized controlled trial
Participants: Undergraduate medical students above the age of 18 years with poor sleep quality.
Intervention: One arm will receive mindfulness based therapy and the other arm will receive sleep hygiene education.
Main outcome measure: To assess the quality of sleep and severity of insomnia in both the arms at baseline and after providing the intervention at the end of 4 weeks and 12 weeks. |