Nursing Interventions
Conditions
Keywords
nursing intervention, sleep quality,
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.
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.
Interventions
OTHERArm 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.
Sponsors
Norther Private Collage of Nursing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model 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 interviewing. Control Group: Participants received standard routine dialysis care without any structured functional, sleep, or psychological interventions.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional performance (KPS) | 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 |
Countries
Egypt, Saudi Arabia
Outcome results
None listed