| CTRI Number |
CTRI/2026/03/105822 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomized control trial to determine the Effect of nurse-led psychological intervention on selected physiological and behavioral parameters among children with childhood trauma studying at residential schools of Himachal Pradesh |
|
Scientific Title of Study
|
A randomized control trial to determine the effect of nurse led psychological intervention on selected physiological and behavioral parameters among children with childhood trauma studying at selected residential schools of himachal pradesh |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bharti choudhary |
| Designation |
Postgraduate |
| Affiliation |
Eternal university |
| Address |
Akal college of nursing baru sahib Himachal Pradesh 173101
Akal college of nursing baru sahib Himachal Pradesh 173101
Sirmaur
HIMACHAL PRADESH
173101
India |
| Phone |
9816194530 |
| Fax |
|
| Email |
bhartichoudhary1891099@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anupama |
| Designation |
Professor |
| Affiliation |
Eternal university |
| Address |
Akal college of nursing baru sahib Himachal Pradesh 173101
Akal college of nursing baru sahib Himachal Pradesh
Sirmaur
HIMACHAL PRADESH
173101
India |
| Phone |
8618549669 |
| Fax |
|
| Email |
anupama@eternaluniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Anupama |
| Designation |
Professor |
| Affiliation |
Eternal university |
| Address |
Akal college of nursing baru sahib Himachal Pradesh 173101
Akal college of nursing baru sahib Himachal Pradesh
Sirmaur
HIMACHAL PRADESH
173101
India |
| Phone |
8618549669 |
| Fax |
|
| Email |
anupama@eternaluniversity.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bharti choudhary |
| Address |
Akal college of nursing baru sahib Himachal Pradesh 173101 |
| 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 |
| Principal |
P.M Shri Jawahar Navodaya Vidyalaya |
P.M Shri Jawahar Navodaya Vidyalaya Nahan District Sirmaur Himachal Pradesh Pin 173001
Sirmaur
HIMACHAL PRADESH |
01702292791
jnvsirmaur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Akal Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
childhood trauma among children(psychological and behavioral problems) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
only pre test and post test was conducted and no intervention was given to control group. |
| Intervention |
Nurse led psychological intervention |
Arm1 intervention group
children who receive the nurse led psychological intervention. each session is 30 minutes to 45 minutes
Arm2 Control group
children who do not receive the intervention and only get routine care |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Residential school who are
1 male and female age group 10 to 16 year
2 willing to participate in the study
3 children with history of childhood trauma |
|
| ExclusionCriteria |
| Details |
1 students who are absent during data collection
2 unable to provide required information |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in physiological and behavioral parameters among children with childhood trauma |
baseline (before intervention) and after 1 month of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/03/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to assess the effect of nurse-led Psychological intervention on physilogical and behavioral parameters among children with childhood trauma studying in selected residential schools in district sirmaur Himachal Pradesh. A total of 60 children aged 10-16 years will be selected and randomly allocated into intervention and control groups. The intervention group will receive a nurse-led psycholgical intervention for one month while the control group will receive routine care. Physiological and Behavioral parameters will be assesses at baseline and after completion of the intervention to determine the effectiveness of the intervention. |