HemodialysisNCT07814469
Calm in the Storm: Reducing Night Pain and Enhancing Sleep Through a Nurse- Led Benson's Relaxation Intervention in Hemodialysis Patients
A study testing Benson's Relaxation Intervention in people with Hemodialysis and Hemodialysis Patient, run by Alexandria University at 1 site in Egypt.
Trial summary
Patients undergoing maintenance hemodialysis (HD) frequently experience persistent pain and sleep disturbances which negatively influence their quality of life and overall wellbeing. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Hemodialysis, Hemodialysis Patient
- What is being tested?
- Benson's Relaxation Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 30 Apr 2025
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and female patients
- aged 20 to 65 years,
- undergoing maintenance HD for at least 6 months
Who cannot join
- Patients with cognitive impairment and psychiatric disorders
- Patients receiving pharmacological or nonpharmacological interventions for sleep
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Al-Mowasat Alexandria University Hospital
Alexandria, Alexandria Governorate
About this study
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.
Read the detailed description
Hemodialysis patients commonly experience a substantial symptom burden including high levels of stress, pain, sleep disturbances, and diminished QoL. Despite advances in medical management, these symptoms often remain inadequately addressed through pharmacological approaches alone. Exploring BRT as a complementary, non-pharmacological nursing intervention may help alleviate these symptoms and improve overall well-being. Incorporating such evidence-based, low cost, and easily applicable intervention into routine nursing care may enhance patient comfort, promote psychological wellbeing and improve overall QoL. Furthermore, the study findings are anticipated to support the integration of holistic, patient centered care approaches in nephrology nursing practice and to strengthen the growing body of evidence supporting relaxation-based interventions in chronic disease management
- Conditions
- Hemodialysis, Hemodialysis Patient
- Being tested
- Benson's Relaxation Intervention
- Keywords
- Benson's Relaxation Technique, Hemodialysis, Pain, Sleep Quality, Nurse-Led Intervention
- Medical subject headings
- Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benson's Relaxation InterventionOther
Benson's Relaxation Intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Benson's Relaxation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
night pain
Night Pain Severity and quality Assessed Using the Short-Form McGill Pain Questionnaire (SF-MPQ)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start1 Jan 2025
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 1 arm: control group - 1 arm: study group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Rabie, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814469
- Sponsor's protocol ID
- Hemodialysis
- Status last verified
- Sep 2026
- First submitted
- 22 Apr 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calm in the Storm: Reducing Night Pain and Enhancing Sleep Through a Nurse- Led Benson's Relaxation Intervention in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07814469
- Acronym / sponsor ID
- Hemodialysis
- Conditions
- Hemodialysis, Hemodialysis Patient
- Keywords
- Benson's Relaxation Technique, Hemodialysis, Pain, Sleep Quality, Nurse-Led Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 11 Sep 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.
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.
Detailed description
Hemodialysis patients commonly experience a substantial symptom burden including high levels of stress, pain, sleep disturbances, and diminished QoL. Despite advances in medical management, these symptoms often remain inadequately addressed through pharmacological approaches alone. Exploring BRT as a complementary, non-pharmacological nursing intervention may help alleviate these symptoms and improve overall well-being. Incorporating such evidence-based, low cost, and easily applicable intervention into routine nursing care may enhance patient comfort, promote psychological wellbeing and improve overall QoL. Furthermore, the study findings are anticipated to support the integration of holistic, patient centered care approaches in nephrology nursing practice and to strengthen the growing body of evidence supporting relaxation-based interventions in chronic disease management
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1 arm: control group - 1 arm: study group
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Participants receive routine hemodialysis care without the Benson's Relaxation intervention. |
| Benson's Relaxation Intervention | Experimental | Other: Benson's Relaxation InterventionParticipants receive the nurse-led Benson's Relaxation intervention in addition to their usual hemodialysis care. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult male and female patients
- aged 20 to 65 years,
- undergoing maintenance HD for at least 6 months
Key exclusion criteria (2 listed)
- Patients with cognitive impairment and psychiatric disorders
- Patients receiving pharmacological or nonpharmacological interventions for sleep
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 |
|---|---|---|
| Benson's Relaxation InterventionBenson's Relaxation Intervention | Other | Benson's Relaxation Intervention |
Primary outcome
night pain
Time frame: 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
Night Pain Severity and quality Assessed Using the Short-Form McGill Pain Questionnaire (SF-MPQ)
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 11 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Benson's Relaxation Intervention in people with Hemodialysis and Hemodialysis Patient, run by Alexandria University at 1 site in Egypt.
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 3 inclusion and 2 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 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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. 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?
night pain (time frame: 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). 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 11 Sep 2026.