NCT07454577

Nurse Led Interventions on Functional Trajectories, Sleep Quality, and Psychological Distress in Hemodialysis Patients

Effectiveness of Integrated Nurse-Led Interventions on Functional Trajectories, Sleep Quality, and Psychological Distress in Hemodialysis Patients: A Six-Month Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Norther Private Collage of Nursing · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled clinical trial was conducted to evaluate the effectiveness of an integrated nurse-led multidimensional intervention on functional performance, sleep quality, and psychological distress among patients undergoing maintenance hemodialysis in Egypt. A total of 220 patients were randomly assigned to either an intervention group receiving structured nursing care or a control group receiving routine dialysis care. Outcomes were assessed at baseline, 12 weeks, and 6 months. The primary objective was to determine whether the intervention improved functional trajectories, while secondary objectives included evaluating its effects on sleep quality and psychological distress.

Detailed description

End-stage renal disease (ESRD) patients receiving maintenance hemodialysis frequently experience progressive functional decline, impaired sleep quality, and high levels of anxiety and depression. Despite routine dialysis management, these multidimensional burdens remain insufficiently addressed within standard care in Egyptian renal units. This parallel-group, single-blind randomized controlled trial was conducted in two tertiary governmental hemodialysis centers in Egypt between March 2024 and January 2025. Eligible participants were adults diagnosed with ESRD and receiving hemodialysis for at least six months. Following baseline assessment, participants (N = 220) were randomly allocated in a 1:1 ratio to: Intervention group (n = 110): Received a 12-week integrated nurse-led care program including intradialytic functional training, structured sleep optimization counseling, and brief psychological support strategies. Control group (n = 110): Received routine dialysis care without additional structured interventions.

Conditions

• Nursing Interventions

Interventions

Type	Name	Description
OTHER	Arm Description: Intervention Group: Participants received a 12-week integrated nurse-led multidimensional program, delivered twice weekly during dialysis sessions (30-40 minutes each), including: Fun	Participants received a 12-week Arm Description: Intervention Group: Participants received a 12-week integrated nurse-led multidimensional program, delivered twice weekly during dialysis sessions (30-40 minutes each), including: Functional training: Low-to-moderate intradialytic exercises, progressive mobility training, and energy conservation strategies. Sleep optimization: Sleep hygiene education, relaxation techniques, and behavioral sleep scheduling. Psychological support: Brief cognitive-behavioral strategies, emotional coping skills, and motivational interv, delivered twice weekly during dialysis sessions (30-40 minutes each), including: Functional training: Low-to-moderate intradialytic exercises, progressive mobility training, and energy conservation strategies. Sleep optimization: Sleep hygiene education, relaxation techniques, and behavioral sleep scheduling. Psychological support: Brief cognitive-behavioral strategies, emotional coping skills, and motivational interviewing.

Timeline

• Start date: 2025-08-05
• Primary completion: 2026-01-28
• Completion: 2026-02-14
• First posted: 2026-03-06
• Last updated: 2026-03-06

Locations

2 sites across 2 countries: Egypt, Saudi Arabia