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

March 3, 2026 updated by: Amal Hashem, Norther Private Collage of Nursing

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Minya Governorate
      • Minya, Minya Governorate, Egypt, 4444
        • Minia University Egypt
  • Saudi Arabia
    • Norther Border
      • Arar, Norther Border, Saudi Arabia, 1447
        • Norther Private Colleague of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group

Intervention Group: Participants received a 12-week integrated nurse-led multidimensional program such as exercise training , relaxation technique, emotional support , 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.
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.
Placebo Comparator: control group
placebo comparator: Participants received standard routine dialysis care such as medical treatment , drug therapy only
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norther Private Collage of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2025

Primary Completion (Actual)

January 28, 2026

Study Completion (Actual)

February 14, 2026

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • associate professor (Nancy Maher)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Study Data/Documents

  1. Clinical Study Report

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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