| CTRI Number |
CTRI/2026/01/102371 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Sensation Awareness Focused Training on Stress, Anxiety and Depression among Family Members of ICU Patients |
|
Scientific Title of Study
|
A randomized controlled trial to assess the effectiveness of Sensation Awareness Focused Training (SAFT) on
symptoms of Post Intensive Care Syndrome-Family(PICS-F) among the attendants of patients admitted in
ICU in a selected tertiary care hospital from eastern India. |
| Trial Acronym |
SAFT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DIPANWITA PAL |
| Designation |
MSc Nursing |
| Affiliation |
All India Institute Of Medical Sciences, Kalyani |
| Address |
All India Institute of Medical Sciences (AIIMS) Hospital,
NH-34 Connector, Basantpur, Saguna,
Kalyani, Nadia District, West Bengal – 741245
Nadia
WEST BENGAL
741245
India |
| Phone |
7001176402 |
| Fax |
|
| Email |
dipanwita.mscnursing-2025@aiimskalyani.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajita Devi |
| Designation |
Assistant Professor, College of Nursing, All India Institute Of Medical Sciences, Kalyani |
| Affiliation |
All India Institute Of Medical Sciences, Kalyani |
| Address |
All India Institute of Medical Sciences (AIIMS) Hospital,
NH-34 Connector, Basantpur, Saguna,
Kalyani, Nadia District, West Bengal – 741245
Nadia
WEST BENGAL
741245
India |
| Phone |
8638648596 |
| Fax |
|
| Email |
rajita.nursing@aiimskalyani.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Rajita Devi |
| Designation |
Assistant Professor, College of Nursing, All India Institute Of Medical Sciences, Kalyani |
| Affiliation |
All India Institute Of Medical Sciences, Kalyani |
| Address |
All India Institute of Medical Sciences (AIIMS) Hospital,
NH-34 Connector, Basantpur, Saguna,
Kalyani, Nadia District, West Bengal – 741245
Nadia
WEST BENGAL
741245
India |
| Phone |
8638648596 |
| Fax |
|
| Email |
rajita.nursing@aiimskalyani.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Kalyani |
| Address |
All India Institute of Medical Sciences (AIIMS) Hospital,
NH-34 Connector, Basantpur, Saguna,
Kalyani, Nadia District, West Bengal – 741245 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Anjum Naz |
All India Institute of Medical Sciences, Kalyani ICUs |
Department of Anesthesiology, ICU Complex, Critical Care Block, First Floor
Nadia
WEST BENGAL |
7001176402
anjum.anesth@aiimskalyani.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, Kalyani |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
According to ICD 10, Z63.6 Stress related to caring for a sick family member |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sensation Awareness Focused Training (SAFT). |
Sensation Awareness Focused Training (SAFT) is a structured awareness-based behavioral intervention provided to attendants of patients admitted in the Intensive Care Unit. The intervention focuses on enhancing awareness of bodily sensations, emotional responses, and stress reactions through guided awareness exercises and verbal instructions. SAFT is delivered over a period of three consecutive days, with each session lasting approximately 20–30 minutes. The training aims to improve coping and reduce psychological symptoms associated with Post Intensive Care Syndrome-Family (PICS-F). |
| Comparator Agent |
Standard Care |
Participants in the comparator group receive standard care provided to attendants of patients admitted in the Intensive Care Unit, which includes routine information and support as per hospital policy. No structured behavioral or awareness-based training is provided. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA
For Family Members:
Adult aged eighteen years or above
Identified as the primary family member or primary decision-maker for an adult patient currently
admitted to the ICU
Patient expected to remain in ICU for at least forty-eight hours at time of enrolment (allowing
sufficient time to deliver the intervention)
Able to speak and read Bengali or Hindi, or English sufficiently to complete outcome measures
Willing and able to provide informed consent
Available to receive intervention sessions for 3 days during patient’s ICU stay
Able to be contacted for follow-up assessments at 3rd and 15th day.
For Patients
Admitted to adult ICU (age eighteen years or above)
Expected ICU length of stay of at least forty-eight hours based on clinical assessment
Presence of identifiable primary family member meeting eligibility criteria |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA
For Family Members:
Family member with diagnosed severe mental illness (schizophrenia, bipolar disorder, current major
depressive episode) that would preclude participation or require specialized mental health care beyond
the scope of the intervention
Family member actively receiving psychotherapy or psychiatric treatment for anxiety, depression, or
PTSD at time of enrolment
Family member with visual impairment and neurological condition that would prevent ability to follow facilitator’s hand movements during SAFT Family member who is healthcare professional working in ICU setting (to avoid potential confounding due to professional knowledge and experience)
Patient expected to be brain-dead or undergoing determination of death protocols (as family experience differs qualitatively)
Patient admitted primarily for palliative care or comfort measures only at time of enrolment
For Patients
Expected ICU length of stay less than forty-eight hours
No identifiable primary family member available
Readmission to ICU during same hospitalization if family member was previously enrolled. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Post Intensive Care Syndrome Family symptoms(stress, anxiety and depression symptoms and complicated grief) severity among family members of ICU patients |
Baseline, Day 3 post-intervention, Day 15 follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PICS-F Symptoms severity in relation to selected demographic variables (age, gender, relationship to patient) and clinical variables (patient illness severity) among family members of ICU patients |
Baseline, Day 3 post-intervention, Day 15 follow-up |
| Interrelationships among PICS-F symptom domains (anxiety, depression, post-traumatic stress, and complicated grief) among family members of ICU patients |
Baseline, Day 3 post-intervention, Day 15 follow-up |
| Correlation between individual PICS-F symptoms (anxiety, depression, post-traumatic stress, and complicated grief) among family members of ICU patients |
Baseline, Day 3 post-intervention, Day 15 follow-up |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
01/04/2026 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
Modification(s)
|
This randomized controlled trial aims to examine the effectiveness of Sensation Awareness Focused Training (SAFT), a structured awareness-based intervention, on symptoms of Post Intensive Care Syndrome Family (PICS-F) among family members of patients admitted to the Intensive Care Unit. The study will compare family members receiving SAFT for three consecutive days with those receiving standard care. The primary hypothesis is that SAFT will significantly reduce psychological symptoms including anxiety, depression and post-traumatic stress in family members. Secondary objectives include examining associations between demographic and clinical variables and PICS-F symptom severity, exploring interrelationships among PICS-F symptom domains, and evaluating correlations between individual PICS-F symptoms. Assessments will be conducted at baseline, Day 3 post-intervention, and Day 15 follow-up. |