ClinicalTrials.gg
RecruitingNCT07935980Updated Nov 13, 2026

Intradialytic Benson's Relaxation Technique in Patients With Chronic Kidney Disease

An interventional study of Benson's relaxation technique and Control group in Patients With Chronic Kidney Disease, Intradialytic Benson's Relaxation Technique and Dialysis Adequacy, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Updated Nov 13, 2026Newly registeredGo to Updates ↓

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
40 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 16 studies in Sleep Initiation and Maintenance Disorders by Cairo University — 8 open to participants now, 8 under way, none of them phase 3. Sleep Initiation and Maintenance Disorders · Cairo University.

Planned enrollment
6th of 13
60 · median 60
Started
2026
with 3 others
No phase
13 of 16
6 open now
Registered
16th of 16
by date

Among the 16 studies in Sleep Initiation and Maintenance Disorders by Cairo University, this one is the 6th largest by planned enrollment of the 13 interventional ones that give a count, is one of 4 that started in 2026, is one of 13 with no phase, and was the 16th registered.

Sleep Initiation and Maintenance Disorders

2,728 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 728 are open to participants now.

Browse Sleep Initiation and Maintenance Disorders studies →

Open to participants now

8 of the 16 studies in Sleep Initiation and Maintenance Disorders by Cairo University are open now, in 1 country. Recruiting first, the newest first:

2 more — sign in →

By country, each count listing its studies:

All 8 open studies →

Where they have run

Who these studies take

Of the 388 Sleep Initiation and Maintenance Disorders studies recruiting now, 152 (39%) set no upper age limit and 206 (53%) stop at 75 or younger; 59 take children under 18; 108 take healthy volunteers.

This study: 40 Years to 60 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 16 studies in Sleep Initiation and Maintenance Disorders by Cairo University, or all of them as a file.
02

Study summary

The purpose of this study is to determine the impact of benson's relaxation technique on dialysis adequacy and sleep quality among CKD patients.

The intervention will include intradialytic benson's relaxation sessions, and outcomes such dialysis adequacy and sleep quality will be evaluated after 12 weeks of benson's relaxation technique in patients with CKD.

Read the detailed description

A major public health concern, chronic kidney disease is characterized by abnormalities of kidney structure or function that have been present for more than three months and have particular health consequences . Uremia is a clinical condition associated with declining renal function and is characterized by fluid overload, electrolyte imbalances, metabolic abnormalities, and physiological changes. Urea exhibits direct and indirect toxicity to various tissues leading to symptoms such as nausea, vomiting, fatigue, anorexia, muscle cramps, pruritus, and altered mentation.Previous studies reported that poor sleep is one of the most prevalent symptoms experienced by CRD patients most patients because of increase toxins concentrations of plasma (creatinine and urea), anemia, nocturnal hypoxia, and co-morbidities. Benson's relaxation technique is an effective intervention which has been introduced as useful non-pharmacological method which decreases stress over its effect on mental, physical conditions, depression, anxiety, self-steam, enhance sleep and improves the quality of life of hemodialysis patients.

03

Conditions studied

  • Patients With Chronic Kidney Disease
  • Intradialytic Benson's Relaxation Technique
  • Dialysis Adequacy
  • Sleep Quality
04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients of both sexes diagnosed with ESRD (stage 5 CKD).
  2. Ages from 40 to 60 years.
  3. Patients on hemodialysis for at least one year with 2 to 3 sessions per week lasting 3 to 4 hours each.
  4. Their 25 - 34.9 kg/ m2 and under medical supervision.
  5. They are receiving HD though an uncomplicated arm arteriovenous (AV) fistula.
  6. They are in a stable medical, clinical and hemodynamic status.
  7. Individuals don't require lower limb dialysis grafting.

Exclusion criteria

Exclusion Criteria:

  • 1- Patients with resting systolic blood pressure more than 200 mm Hg \& or diastolic blood pressure greater than 120 mm Hg.

    2- Patients with uncontrolled diabetes mellitus, peripheral neuropathy, hepatic disorders (hepatic cancer, hepatitis) and infectious illness ( / AIDS).

    3- Patients with mental health problems and cognitive impairment owing to the inability to educate them how to perform relaxation techniques.

    4- Any patient who missed more than two weeks of the program or want to terminate the program.

    5- Severe Obesity (> 35). 6- Patients had a previous history of psychiatric disorders. 7- Uncontrolled pulmonary disease (e.g. exaggerated acute asthma, exaggerated acute chronic obstructive lung disease).

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Study group (benson's relaxation technique)

    Thirty patients of both gender will receive Benson's relaxation technique 3 times / week for 12 weeks with duration 10-20 minutes at the end of second hour of dialysis session and aerobic exercise in addition to their medical treatment.

    Behavioral: Benson's relaxation technique

  • Active comparator
    Control group

    Thirty patients of both gender will receive the same aerobic exercise in addition to their medical treatment. Aerobic exercise: by using mini pedal bike for 12 weeks , 30 minutes in the first 2 hours of dialysis session

    Other: Control group

Interventions

  • BehavioralBenson's relaxation technique

    Research has shown that the Benson Relaxation Technique (BRT) is an effective strategy for decreasing sleep disruptions in older persons and hemodialysis patients with hypertension focuses on deep rhythmic breathing and mental focusing rather than physical muscle tensing. Steps : 1\. Find a quiet environment: Sit or lie down in a comfortable, quiet space where you will not be disturbed. 2. Close your eyes: Gently close your eyes to block out visual distractions.3. Relax your muscles: Release all tension from your body, moving progressively from your feet up to your face (or top of your head).4. Breathe through your nose: Become aware of your natural breathing. As you exhale, silently repeat a chosen focus word or phrase-such as "one", "calm", or "peace"-to yourself (e.g., inhale... exhale, "one").5. Maintain a passive attitude: When distracting thoughts drift into your mind, do not fight them or judge yourself.6.Practice for 10 to 20 minutes7.Transition slowly

  • OtherControl group

    Aerobic ex by using mini pedal exerciser without involving benson's relaxation technique. for 12 weeks , 30 minutes in the first 2 hours of dialysis session

06

What researchers measure

Primary outcomes

  1. Dialysis adequacy

    Dialysis adequacy will be assessed using URR (Urea Reduction Ratio) and KT/V measured pre- and post-intervention to determine the effectiveness of the treatment in improving hemodialysis efficiency.

    Time frame: 12 weeks

Secondary outcomes

  1. Change in Sleep Quality Measured by the Pittsburgh Sleep Quality Index (PSQI)

    Sleep Quality will be assessed by PSQI pre and post intervention to determine the effectiveness of (sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction)

    Time frame: 12 weeks

  2. Change in Anxiety Score Measured by the Hospital Anxiety and Depression Scale (HADS)

    Anxiety symptoms will be assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). Changes in anxiety scores will be compared between baseline and follow-up.

    Time frame: 12 weeks

  3. Change in Depression Score Measured by the Hospital Anxiety and Depression Scale (HADS)

    Depressive symptoms will be assessed using the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). Changes in depression scores will be compared between baseline and follow-up.

    Time frame: 12 weeks

  4. Change in Systolic and Diastolic Blood Pressure

    Systolic and diastolic blood pressure will be measured using a digital sphygmomanometer to assess changes in blood pressure following the intervention.

    Time frame: 12 weeks

  5. Change in Functional Performance Measured by the 2-Minute Walk Test (2MWT)

    Functional performance will be assessed using the 2-Minute Walk Test (2MWT), measured by the distance walked in meters during two minutes.

    Time frame: 12 weeks

  6. Change in Kidney Disease Quality of Life (KDQOL-36) Scores

    Health-related quality of life will be assessed using the Kidney Disease Quality of Life 36-item Short Form survey (KDQOL-36), including its kidney disease-specific and generic health-related quality-of-life domains.

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
  • Quweisna central hospital
    Cairo, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Jul 2027, 7 months later.

Of 1,211 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's planned 7 months is below that.

Counting every sponsor, half of 1,289 studies reached it within 15 months; a quarter within 6 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 9, 2026
First posted
Nov 13, 2026
StartEst.
Dec 2026
Primary completionEst.
Jul 2027
CompletionEst.
Sep 2027
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07935980
Lead sponsor
Cairo University
Responsible party
Manar Tarek Mostafa Morsy (Principal Investigator, Cairo University) — Principal investigator
First posted
Nov 13, 2026
Start date
Dec 2026 (estimated)
Primary completion
Jul 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Nov 13, 2026

Study contacts

Manar Tarek Mostafa Morsy, BSc in physical therapy
Contact
drmtarekmali@gmail.com
+0201200469648

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion