Data Sheet 1_Evaluating a stress management intervention effects on post-ICU syndrome in families: study protocol for a single-center, prospective, parallel-design, randomized controlled trial.docx

Aim(s)The aim of this study is to assess the impact of a stress management intervention on the prevention of Post-Intensive Care Syndrome-Family (PICS-F).
DesignA single-center, prospective, parallel-design, randomized controlled trial (RCT) study.
MethodsThis study will recruit 56 family members of ICU patients from a hospital in China. Participants will be randomly assigned to either the experimental group or the control group. The control group will receive standard care, and the experimental group will receive standard care plus a stress management intervention. The primary outcome is a composite score of psychological distress (integrating perceived stress, anxiety, and depression) measured immediately post-intervention. Secondary outcomes include the longitudinal trajectories of individual psychological symptoms (stress, anxiety, depression), symptoms of post-traumatic stress, and sleep quality across multiple follow-ups up to 90 days. Data analysis will be performed utilizing IBM SPSS version 27.0 software.
DiscussionThis study protocol describes a RCT aimed at evaluating the effectiveness of the stress management intervention measures in preventing the occurrence of the PICS-F among family members of patients in the intensive care unit.
Clinical trial registrationhttps://www.chictr.org.cn/bin/project/edit?pid=272710, identifier ChiCTR2500102953.