Nursing InterventionsEffectivenessNCT07454577
Nurse Led Interventions on Functional Trajectories, Sleep Quality, and Psychological Distress in Hemodialysis Patients
A study testing 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 in people with Nursing Interventions, run by Norther Private Collage of Nursing at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Nursing Interventions
- What is being tested?
- 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 5 Aug 2025to 14 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- Cognitive impairment or severe psychiatric disorder
- Terminal comorbid condition
- Hospitalization within the previous month
- Participation in another interventional study
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Saudi Arabia1 site
Norther Private Colleague of Nursing
Arar, Norther Border, 1447
About this study
Official title: 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.
Read the 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
- Being tested
- 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
- Keywords
- nursing intervention, sleep quality,
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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: FunOther
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.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | 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. Receives: 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 |
| control group | Placebo comparator | placebo comparator: Participants received standard routine dialysis care such as medical treatment , drug therapy only Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start5 Aug 2025
- Primary completion28 Jan 2026
- Study completion14 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing InterventionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norther Private Collage of Nursing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Hashem, Norther Private Collage of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454577
- Sponsor's protocol ID
- associate professor
- Acronym
- Effectiveness
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Integrated Nurse-Led Interventions on Functional Trajectories, Sleep Quality, and Psychological Distress in Hemodialysis Patients: A Six-Month Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07454577
- Acronym / sponsor ID
- Effectiveness / associate professor
- Conditions
- Nursing Interventions
- Keywords
- nursing intervention, sleep quality,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Norther Private Collage of NursingUniversity, hospital or other
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 14 Feb 2026 (actual)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | 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: FunIntervention 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 comparator | 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: Funplacebo comparator: Participants received standard routine dialysis care such as medical treatment , drug therapy only |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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: FunParticipants 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. | Other | control group, study group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 in people with Nursing Interventions, run by Norther Private Collage of Nursing at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt, Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional performance (KPS) (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.