| CTRI Number |
CTRI/2025/08/092936 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Brief Mindfulness and Self compassion based intervention] |
| Study Design |
Other |
|
Public Title of Study
|
Can a Short Training Program in Sikkim (Brief mindfulness and self-compassion based intervention)teach Nursing Students to Stay Calm and Be Kind to Themselves Help Them Adjust Better to College Life? |
|
Scientific Title of Study
|
A study of effectiveness and feasibility of a group based brief mindfulness and self-compassion-based intervention on college adjustment and coping self-efficacy among nursing students in Sikkim |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Songmit Lepcha |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Songmit Lepcha |
| Designation |
Assistant Professor |
| Affiliation |
Sikkim Professional University |
| Address |
8th Mile Budang, Sikkim Professional University, Soreng Sikkim
Department of Nursing, Room No. 2
West
SIKKIM
737121
India |
| Phone |
8370959167 |
| Fax |
|
| Email |
songmitsitling01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geeta S Soohinda |
| Designation |
Associate Professor |
| Affiliation |
Sikkim Manipal Institute of Medical Sciences |
| Address |
Department of Psychiatry, Central Referral Hospital, Sikkim Manipal Institute of Medical Sciences, Sikkim Manipal University, 5th Mile Tadong, Gangtok, Sikkim, Pin: 737102, India
East
SIKKIM
737102
India |
| Phone |
8348014335 |
| Fax |
|
| Email |
gsoohinda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geeta S Soohinda |
| Designation |
Associate Professor |
| Affiliation |
Sikkim Manipal University |
| Address |
Sikkim Manipal Institute of Medical Sciences, Sikkim Manipal University, Central Referral Hospital, Department of Psychiatry, Room No. 3, 5th Mile Tadong, Gangtok Sikkim
East
SIKKIM
737102
India |
| Phone |
09943029904 |
| Fax |
|
| Email |
geeta.s@smims.smu.edu.in |
|
|
Source of Monetary or Material Support
|
| Sikkim Manipal College of Nursing, Sikkim Manipal University, 5th Mile Tadong Gangtok Sikkim
Pin Code: 737102
Country: India |
|
|
Primary Sponsor
|
| Name |
Sikkim Manipal College of Nursing |
| Address |
Sikkim Manipal University, 5th Mile Tadong, Gangtok Sikkim, Pin 737102, India |
| Type of Sponsor |
Other [(Self Funding)] |
|
|
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 Geeta S Soohinda |
Sikkim Manipal University |
Sikkim Manipal College of Nursing, Department of Nursing, Classroom No. 1, 5th Mile Tadong, Gangtok Sikkim, Pin 737102, India
East
SIKKIM |
9943029904
geeta.s@smims.smu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMIMS INSTITUTION ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
B.Sc. Nursing Students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brief Mindfulness and self compassion based intervention |
An initial session will be organized to screen and orient participants. Weekly 60-minute lessons will be held throughout a three-month semester, with the intervention lasting five weeks, including the initial session for assessment and introduction. An abridged intervention will be implemented utilizing a handbook created with the supervisors assistance. Participants will be given guided mindfulness recordings and urged to practice for at least 10 minutes a day, five days per week. The Remind app will be used to offer mobile support and reminders. Following the 4-week intervention, a post-intervention assessment will be carried out. After three months, a follow-up assessment will be conducted. The feasibility and acceptability will be assessed using a structured questionnaire. |
| Comparator Agent |
NIL |
This study follows a one-group pre-test post-test design. Therefore, no comparator or control group is included. All participants will receive the same intervention.
The intervention is a group-based brief mindfulness and self-compassion-based intervention, designed to enhance college adjustment and coping self-efficacy among nursing students. The intervention will be delivered over a period of 4 weeks, with weekly in-person sessions (once per week), each session lasting approximately 60 minutes.A post-test assessment will be conducted immediately after the 4-week intervention, and a follow-up assessment will be done after 3 months to evaluate sustainability.
Since all participants receive the same intervention, there is no comparator arm in this study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Inclusion criteria
The inclusion criteria include the B.Sc. Nursing students who: - are enrolled in 1st Year B.Sc. Nursing Programme - are aged 18 years and above - willing to participate in the study - able to attend once weekly session for 4 weeks
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
The exclusion criteria include the B.Sc. Nursing students who: - do not give the written consent for the study - have undergone stress management interventions in the last 1 year - screened positive for contraindications (current drug addiction, current
psychosis, serious untreated bipolar disorder) currently practising
mindfulness on a daily basis. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Brief
Self-Compassion Scale, General Self-Efficacy Scale (GSE), Brief Resilient Coping
Scale (BRCS), Contingencies of Self-Worth Scale (CSWS), Student Adjustment to
College Questionnaire (SACQ), Body Appreciation Scale (BAS), State-Trait Anxiety
Inventory (STAI), Toronto Mindfulness Scale (TMS). |
The time point will be baseline and every week for 5 weeks (including orientation) followed by follow up, 3 months post intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the effect of brief mindfulness and self-compassion-based intervention
on college adjustment and coping self-efficacy among the study population.
To determine the feasibility and acceptability of brief mindfulness and self
compassion-based intervention.
To determine the effect of brief mindfulness and self-compassion-based intervention
on body image among the study population. |
3 years |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
03/11/2025 |
| 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="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
|
The purpose of this study is to determine the efficacy and feasibility of a brief group-based mindfulness and self-compassion intervention for college adjustment and coping self-efficacy among first-year nursing students in Sikkim. The intervention will last five weeks, including weekly 60-minute meetings, guided daily practices, and cellphone reminders. Validated psychological scales will be used to assess participants at baseline, post-intervention, and three months later. The study will also assess body image, anxiety, and self-esteem. Feasibility and acceptance will be assessed using structured questionnaires. Data would be collected at SMCON in Gangtok using ethical standards. The intended outcome is better emotional resilience, stress management, and college adjustment among participants, which supports the incorporation of mindfulness and self-compassion techniques into nursing education to promote mental health and academic success. |