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

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.

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Key information

Conditions

Nursing Interventions Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minia University Egypt, Minya, Minya Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosed with end-stage renal disease (ESRD)
Receiving hemodialysis ≥ 6 months
Aged ≥ 18 years to 55 years
Clinically stable during the previous 3 months
Able to communicate in Arabic
Provided written informed consent Exclusion Criteria
Cognitive impairment or severe psychiatric disorder
Terminal comorbid condition
Hospitalization within the previous month
Participation in another interventional study

Treatment and study plan

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

Other

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.

Primary outcomes

Functional performance (KPS)

Time frame: 6 month

The Karnofsky Performance Status (KPS) scale is a widely used measure of overall functional ability and independence in patients with chronic illnesses. Scores range from 0 to 100, where higher scores indicate better functional capacity:

100: Normal, no complaints, no evidence of disease

80-90: Able to carry on normal activity with minor signs/symptoms

50-70: Requires varying degrees of assistance

Sponsors and collaborators

Lead sponsor

Norther Private Collage of Nursing

Other

Registry information

Official study title

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

Acronym: Effectiveness

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Mar 6, 2026
Registry last updated: Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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