NCT07814469

Brief Summary

Patients undergoing maintenance hemodialysis (HD) frequently experience persistent pain and sleep disturbances which negatively influence their quality of life and overall wellbeing. Non-pharmacological nurse-led interventions such as Benson's relaxation technique (BRT) may offer a safe and cost-effective approach to alleviate these symptoms. Aim: Evaluate the effect of a nurse-led Benson's relaxation intervention on night pain intensity and sleep quality among HD patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2026

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 11, 2026

Completed
Last Updated

September 11, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

April 22, 2026

Last Update Submit

September 5, 2026

Conditions

Keywords

Benson's Relaxation TechniqueHemodialysisPainSleep QualityNurse-Led Intervention

Outcome Measures

Primary Outcomes (1)

  • night pain

    Night Pain Severity and quality Assessed Using the Short-Form McGill Pain Questionnaire (SF-MPQ)

    baseline before implementation of the BRT, secondly in the second week following four intervention sessions, and thirdly in the fourth week following eight intervention sessions

Study Arms (2)

Usual care

NO INTERVENTION

Participants receive routine hemodialysis care without the Benson's Relaxation intervention.

Benson's Relaxation Intervention

EXPERIMENTAL

Participants receive the nurse-led Benson's Relaxation intervention in addition to their usual hemodialysis care.

Other: Benson's Relaxation Intervention

Interventions

Benson's Relaxation Intervention

Benson's Relaxation Intervention

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult male and female patients
  • aged 20 to 65 years,
  • undergoing maintenance HD for at least 6 months

You may not qualify if:

  • Patients with cognitive impairment and psychiatric disorders
  • Patients receiving pharmacological or nonpharmacological interventions for sleep

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Mowasat Alexandria University Hospital

Alexandria, Alexandria Governorate, Egypt

Location

MeSH Terms

Conditions

PainSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 1 arm: control group - 1 arm: study group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 22, 2026

First Posted

September 11, 2026

Study Start

January 1, 2025

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

September 11, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations