Nurse Led Interventions on Functional Trajectories, Sleep Quality, and Psychological Distress in Hemodialysis Patients
Effectiveness
Effectiveness of Integrated Nurse-Led Interventions on Functional Trajectories, Sleep Quality, and Psychological Distress in Hemodialysis Patients: A Six-Month Randomized Controlled Trial
1 other identifier
interventional
220
2 countries
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2025
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2026
CompletedFirst Submitted
Initial submission to the registry
February 25, 2026
CompletedFirst Posted
Study publicly available on registry
March 6, 2026
CompletedMarch 6, 2026
March 1, 2026
6 months
February 25, 2026
March 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Functional performance (KPS)
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
Study Arms (2)
study group
EXPERIMENTALIntervention 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.
control group
PLACEBO COMPARATORplacebo comparator: Participants received standard routine dialysis care such as medical treatment , drug therapy only
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Cognitive impairment or severe psychiatric disorder
- Terminal comorbid condition
- Hospitalization within the previous month
- Participation in another interventional study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Minia University Egypt
Minya, Minya Governorate, 4444, Egypt
Norther Private Colleague of Nursing
Arar, Norther Border, 1447, Saudi Arabia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Single-blind design: Outcome assessors were blinded to group allocation to reduce measurement bias. Participants and intervention nurses were not blinded due to the nature of the intervention.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
February 25, 2026
First Posted
March 6, 2026
Study Start
August 5, 2025
Primary Completion
January 28, 2026
Study Completion
February 14, 2026
Last Updated
March 6, 2026
Record last verified: 2026-03