Skip to content

Effect of Sensation Awareness Focused Training on Stress, Anxiety and Depression among Family Members of ICU Patients

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. - SAFT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/102371
Enrollment
76
Registered
2026-01-28
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Sensation Awareness Focused Training (SAFT).: Sensation Awareness Focused Training (SAFT) is a structured awareness-based behavioral intervention provided to attendants of patients admi

Sponsors

All India Institute of Medical Sciences, Kalyani
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Change in Post Intensive Care Syndrome Family symptoms(stress, anxiety and depression symptoms and complicated grief) severity among family members of ICU patientsTimepoint: Baseline, Day 3 post-intervention, Day 15 follow-up

Secondary

MeasureTime frame
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 patientsTimepoint: 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 patientsTimepoint: 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 patientsTimepoint: Baseline, Day 3 post-intervention, Day 15 follow-up

Countries

India

Contacts

Public ContactRajita Devi

All India Institute Of Medical Sciences, Kalyani

rajita.nursing@aiimskalyani.edu.in8638648596

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026