| CTRI Number |
CTRI/2024/08/072415 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
10/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of psychological counselling on stress felt by family caregivers of patients admitted in an intensive care unit |
|
Scientific Title of Study
|
Role of psychological interventions on burnout score of family caregivers of patients admitted in an intensive care unit |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vanita Ahuja |
| Designation |
Professor |
| Affiliation |
Government medical college and hospital sector 32 chandigarh |
| Address |
Department of Anesthesia and intensive care level 5 D block GMCH sector 32 Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121649 |
| Fax |
|
| Email |
vanitaahujameetings2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vanita Ahuja |
| Designation |
Professor |
| Affiliation |
Government medical college and hospital sector 32 chandigarh |
| Address |
Department of Anesthesia and intensive care level 5 D block GMCH sector 32 Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121649 |
| Fax |
|
| Email |
vanitaahujameetings2020@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jaskaran Singh Gujral |
| Designation |
Junior Resident |
| Affiliation |
Government medical college and hospital sector 32 |
| Address |
Department of Anaesthesia and Intensive Care
D Block level 5
Government medical college and hospital sector 32 chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9602062818 |
| Fax |
|
| Email |
dr.jaskaransinghgujral@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and hospital sector 32 Chandigarh, INDIA
PIN-160030 |
|
|
Primary Sponsor
|
| Name |
Department of anesthesia and intensive care |
| Address |
level 5 D block GMCH sector 32 Chandigarh,INDIA
PIN-160030 |
| Type of Sponsor |
Government 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 |
| Dr Vanita Ahuja |
Government Medical College and Hospital |
ROOM NUMBER 521
D block Level 5
GMCH
DEPRATMENT OF ANAESTHESIA AND INTENSIVE CARE
Sector 32
160030
Chandigarh
CHANDIGARH |
9646121649
vanitaahujameetings2020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GMCH Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Caregivers of patients admitted in Intensive care unit |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No psychological intervention |
Standard counselling as per ICU interactions will be given |
| Intervention |
Psychological interventional schedule |
Total 2 hours and 45 minutes or 165 minutes
It will include 7 Sessions
1. Understanding Stress awareness and burnout. Taken by clinical psychologist for 30 minutes.
2. Understanding cognitive triad of thought, behavior and feeling. Session will be taken by clinical psychologist as group discussion for 20 minutes.
3. Ventilation session as group discussion for 30 minutes.
4. Cognitive restructuring include healthy emotional coping, problem solving technique with group discussion for 30 minutes.
5. Behavioral technique including mindful meditation, stimulating the 5 senses, grounding technique and breathing activity as group activity for 30 minutes.
6. Query session in which discussing the doubts, fear, and clearing it as group activity for 15 minutes.
7. Feedback session as group activity for 10 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Caregivers will be of blood relation with patient
Average length of stay with patient of 7 days |
|
| ExclusionCriteria |
| Details |
1 Participants unwillingness to participate in study
2 Participants already on psychiatric medications
3 Alcohol and substance abuse |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference between pai and kapur score from pre to post intervention |
pre assessment day 1
post assessment day 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Baseline burnout score of caregivers.
2. Patients condition on admission with APACHE II score, SOFA score for mortality.
3. Correlation of condition of patient in between clinical scales. |
1. Day 1
2. Day 1 and day 2
3. Day 3 and Day 7
|
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 4 |
|
Date of First Enrollment (India)
|
27/08/2024 |
| 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="1"
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
|
In the present study, we will measure the difference in burnout score of family members of patients admitted in ICU using Pai and Kapur assessment score of caregivers after giving psychological intervention as compared to control group in which routine standard counselling will be given as per ICU interaction. Secondary outcome will be baseline caregiver burnout score, clinical assessment of patients admitted in ICU , correlation of condition of patient in between clinical scales (APACHE II and SOFA) and caregivers burnout and brief cognitive behavior intervention on families of patient admitted in ICU. |