Impact of Interactive ICU Diary on Psychological Distress

NCT ID: NCT06512987

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-05-31

Brief Summary

This study investigates the effectiveness of a technology-driven, interactive ICU diary in reducing psychological distress, specifically anxiety, depression, and stress, in ICU patients. A single-blind, parallel-group randomized controlled trial will include 56 conscious ICU patients. The primary outcome measures are the Depression, Anxiety, and Stress Scale-21 (DASS-21) and the EuroQol instrument (EQ-5D), assessed at ICU admission, discharge, and one month post-discharge.

Detailed Description

This study investigates the effectiveness of a technology-driven, interactive ICU diary in reducing psychological distress, specifically anxiety, depression, and stress, in ICU patients. A single-blind, parallel-group randomized controlled trial will include 56 conscious ICU patients, randomly assigned to either the interactive diary group or the standard care group. The interactive diary allows patients to share their feelings and needs via a platform, while family members can send supportive messages, pictures, and videos. Healthcare providers can connect with families and monitor patient conditions through the platform. The primary outcome measures are the Depression, Anxiety, and Stress Scale-21 (DASS-21) and the EuroQol instrument (EQ-5D), assessed at ICU admission, discharge, and one month post-discharge. The expected results indicate that the interactive diary will significantly alleviate psychological distress during the ICU stay and improve post-discharge quality of life, providing valuable insights into enhancing the mental health and overall well-being of ICU patients.

Conditions

Critical Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Interactive ICU Diary Group

Patients in this group will use a technology-driven, interactive ICU diary from the first day of ICU admission until discharge. Through the diary platform, patients can share their feelings and needs, while family members can send supportive messages, pictures, and videos. Healthcare providers will use the platform to connect with families and monitor patient conditions. The goal is to reduce psychological distress, specifically anxiety, depression, and stress, during the ICU stay.

Group Type: EXPERIMENTAL

technology-driven, interactive ICU diary

Intervention Type: OTHER

Through the diary platform, patients can share their feelings and needs, while family members can send supportive messages, pictures, and videos. Healthcare providers will use the platform to connect with families and monitor patient conditions.

routine care

Patients in this group will receive standard ICU care without the use of the interactive ICU diary.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

technology-driven, interactive ICU diary

Through the diary platform, patients can share their feelings and needs, while family members can send supportive messages, pictures, and videos. Healthcare providers will use the platform to connect with families and monitor patient conditions.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 18 years or older
• Clear consciousness and able to communicate in Mandarin, Taiwanese, or Hakka
• Expected ICU stay of at least 72 hours
• Ability to operate a smart device and use social media applications

Exclusion Criteria

• Presence of delirium before joining the study (Intensive Care Delirium Screening Checklist score ≥ 4)
• Physical, auditory, or visual impairments preventing the use of smart devices History of epilepsy, cognitive impairments (e.g., hepatic encephalopathy, dementia), or psychiatric disorders
• Richmond Agitation-Sedation Scale score not between +1 and -1 (indicating excessive sedation or agitation)
• Acute Physiology and Chronic Health Evaluation Score (APACHE-II) > 25 within the first 24 hours of ICU admission (indicating > 50% mortality rate)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hsiao-Yean Chiu

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University

Locations

Taipei Medical University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

N202403088

Identifier Type: -

Identifier Source: org_study_id