Sleep DisturbancePMR & DBNCT07639710
Effect of Progressive Muscle Relaxation and Diaphragmatic Breathing on Sleep Disturbances in Chemotherapy Patients
A study testing Progressive Muscle Relaxation and Diaphragmatic Breathing in people with Sleep Disturbance and Sleep Disorders, run by Cairo University at 1 site in Egypt.
Trial summary
This randomized controlled trial aims to investigate the effect of combined Progressive Muscle Relaxation (PMR) and Diaphragmatic Breathing (DB) techniques on sleep disturbances among patients receiving chemotherapy. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Sleep Disturbance, Sleep Disorders, Cancer
- What is being tested?
- Progressive Muscle Relaxation and Diaphragmatic Breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Aged between 40-60 years
- Both male and female patients
- Currently receiving at least the second cycle of chemotherapy
- Receiving chemotherapy protocols (Zhou et al., 2022)
- PSQI score > 5 at baseline indicating poor sleep quality
- BMI between 18.5 and 30
- Able to provide informed consent
Who cannot join
- Diagnosed with sleep disorders unrelated to chemotherapy (e.g., obstructive sleep apnea)
- Current use of sleep medications or anti-anxiety drugs
- Diagnosed with major psychiatric conditions
- Cognitive impairment limiting understanding of instructions
- Severe cardiopulmonary comorbidities
- Recent participation in relaxation-based clinical trials
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Physical TherapY
Giza, Egypt, 12613
Haidy Nady Ashem, Prof. Dr., 20 1099765185, haidyjojo.hn@gmail.com
Nada Mohamed Yousef, Dr., 20 1021527585, dr.nada123.ny@gmail.com
About this study
Official title: Effect of Progressive Muscle Relaxation and Diaphragmatic Breathing Techniques on Sleep Disturbances in Cancer Patients Undergoing Chemotherapy
This randomized controlled trial aims to investigate the effect of combined Progressive Muscle Relaxation (PMR) and Diaphragmatic Breathing (DB) techniques on sleep disturbances among patients receiving chemotherapy. Sleep disturbances are common among cancer patients undergoing chemotherapy and may negatively affect physical recovery, emotional well-being, and quality of life. Participants will be randomly assigned to either an intervention group receiving PMR and DB training in addition to routine care or a control group receiving routine care alone. Sleep outcomes will be assessed using the Pittsburgh Sleep Quality Index (PSQI), sleep diary records, and wearable sleep monitoring devices. The study seeks to determine whether the combined intervention can improve sleep quality and reduce sleep-related problems in chemotherapy patients.
Read the detailed description
Sleep disturbance is one of the most frequently reported symptoms among patients undergoing chemotherapy. Multiple factors contribute to impaired sleep in this population, including treatment-related side effects, psychological stress, fatigue, pain, and inflammatory responses associated with cancer and its treatment. Poor sleep quality may adversely affect treatment adherence, physical functioning, emotional health, and overall quality of life.
Non-pharmacological interventions have gained increasing attention as safe and cost-effective approaches for managing sleep disturbances in cancer patients. Progressive Muscle Relaxation is a technique that involves systematic contraction and relaxation of specific muscle groups to reduce physical tension and promote relaxation. Diaphragmatic Breathing focuses on slow, deep breathing using the diaphragm to enhance parasympathetic nervous system activity and reduce physiological arousal.
This study will employ a randomized controlled trial design. Eligible chemotherapy patients who meet the inclusion criteria will be randomly allocated to either an intervention group or a control group. Participants in the intervention group will receive a structured program consisting of Progressive Muscle Relaxation and Diaphragmatic Breathing exercises in addition to routine medical care. Participants in the control group will receive routine medical care only.
Sleep outcomes will be evaluated before and after the intervention period using the Pittsburgh Sleep Quality Index, sleep diary recordings, and wearable sleep monitoring devices. The findings of this study may provide evidence regarding the effectiveness of combined relaxation and breathing techniques as supportive interventions for improving sleep quality among patients undergoing chemotherapy.
- Conditions
- Sleep Disturbance, Sleep Disorders, Cancer
- Being tested
- Progressive Muscle Relaxation and Diaphragmatic Breathing
- Keywords
- Chemotherapy, Sleep Disturbance, Sleep Quality, Progressive Muscle Relaxation, Diaphragmatic Breathing, Relaxation Therapy, Cancer Patients, Sleep Diary, PSQI, Wristband Monitor
- Medical subject headings
- Parasomnias, Sleep Wake Disorders, Neoplasms, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle Relaxation and Diaphragmatic BreathingBehavioural
Participants will receive a structured program of Progressive Muscle Relaxation and Diaphragmatic Breathing exercises in addition to traditional treatment . The intervention is designed to promote relaxation, reduce physiological arousal, and improve sleep quality in patients undergoing chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| PMR and Diaphragmatic Breathing Group | Experimental | Participants will receive Progressive Muscle Relaxation and Diaphragmatic Breathing exercises in addition to traditional medical treatment during the study period. Receives: Behavioral: Progressive Muscle Relaxation and Diaphragmatic Breathing |
| Traditional treatment group | No intervention | Participants will receive traditional medical treatment only without the relaxation and breathing intervention program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
Assessment of sleep quality using the Pittsburgh Sleep Quality Index (PSQI). The PSQI total score is measured in points and ranges from 0 to 21, with higher scores indicating poorer sleep quality. A total score greater than 5 indicates clinically significant sleep disturbance. A reduction in the PSQI score from baseline to post-intervention reflects an improvement in sleep quality. Changes in PSQI scores will be used to evaluate the effect of Progressive Muscle Relaxation and Diaphragmatic Breathing exercises on sleep disturbances in patients undergoing chemotherapy.
Measured: Baseline (pre-intervention) and after 4 weeks of intervention (post-intervention)
Secondary outcomes (4)
Sleep Latency
Assessment of the time required to fall asleep, measured in minutes using sleep diary records and a wearable wristband sleep monitor. A decrease in sleep latency reflects improvement in sleep initiation.
Measured: Baseline (pre-intervention) and after 4 weeks of intervention (post-intervention)
Sleep Efficiency
Assessment of sleep efficiency, measured as a percentage (%) of total time spent asleep relative to total time spent in bed, using sleep diary records and a wearable wristband sleep monitor. Higher percentages indicate better sleep efficiency.
Measured: Baseline (pre-intervention) and after 4 weeks of intervention (post-intervention)
Total Sleep Time
Assessment of total sleep duration, measured in hours per night using sleep diary records and a wearable wristband sleep monitor. An increase in total sleep time reflects improvement in sleep quantity.
Measured: Baseline (pre-intervention) and after 4 weeks of intervention (post-intervention)
Number of Nocturnal Awakenings
Assessment of the frequency of awakenings during the night, measured as the number of awakenings per night using sleep diary records and a wearable wristband sleep monitor. A lower number of nocturnal awakenings indicates improved sleep continuity.
Measured: Baseline (pre-intervention) and after 4 weeks of intervention (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups. The intervention group will receive Progressive Muscle Relaxation and Diaphragmatic Breathing exercises in addition to routine treatment , while the control group will receive routine care alone. Outcomes will be assessed before and after the intervention period.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf Said Ahmed Abdelrahman, Cairo University
- Investigators
- Haidy Ashem, Professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639710
- Sponsor's protocol ID
- PMR-DB-2026
- Acronym
- PMR & DB
- Status last verified
- Jun 2026
- First submitted
- 30 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to confidentiality considerations and to ensure protection of patient privacy. The data will be used solely for the purposes of this academic study and will not be made publicly available.
Publications
Mustian, K. M., et al. (2017). Treatment of sleep disturbance in cancer patients. Journal of Clinical Oncology.
Irwin MR. Why sleep is important for health: a psychoneuroimmunology perspective. Annu Rev Psychol. 2015 Jan 3;66:143-72. doi: 10.1146/annurev-psych-010213-115205. Epub 2014 Jul 21.
PubMed 25061767Jerath R, Edry JW, Barnes VA, Jerath V. Physiology of long pranayamic breathing: neural respiratory elements may provide a mechanism that explains how slow deep breathing shifts the autonomic nervous system. Med Hypotheses. 2006;67(3):566-71. doi: 10.1016/j.mehy.2006.02.042. Epub 2006 Apr 18.
PubMed 16624497Jacobson, E. (1938). Progressive Relaxation. University of Chicago Press.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Progressive Muscle Relaxation and Diaphragmatic Breathing Techniques on Sleep Disturbances in Cancer Patients Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT07639710
- Acronym / sponsor ID
- PMR & DB / PMR-DB-2026
- Conditions
- Sleep Disturbance, Sleep Disorders, Cancer
- Keywords
- Chemotherapy, Sleep Disturbance, Sleep Quality, Progressive Muscle Relaxation, Diaphragmatic Breathing, Relaxation Therapy, Cancer Patients, Sleep Diary
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 10 Jun 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 trial aims to investigate the effect of combined Progressive Muscle Relaxation (PMR) and Diaphragmatic Breathing (DB) techniques on sleep disturbances among patients receiving chemotherapy. Sleep disturbances are common among cancer patients undergoing chemotherapy and may negatively affect physical recovery, emotional well-being, and quality of life. Participants will be randomly assigned to either an intervention group receiving PMR and DB training in addition to routine care or a control group receiving routine care alone. Sleep outcomes will be assessed using the Pittsburgh Sleep Quality Index (PSQI), sleep diary records, and wearable sleep monitoring devices. The study seeks to determine whether the combined intervention can improve sleep quality and reduce sleep-related problems in chemotherapy patients.
Detailed description
Sleep disturbance is one of the most frequently reported symptoms among patients undergoing chemotherapy. Multiple factors contribute to impaired sleep in this population, including treatment-related side effects, psychological stress, fatigue, pain, and inflammatory responses associated with cancer and its treatment. Poor sleep quality may adversely affect treatment adherence, physical functioning, emotional health, and overall quality of life.
Non-pharmacological interventions have gained increasing attention as safe and cost-effective approaches for managing sleep disturbances in cancer patients. Progressive Muscle Relaxation is a technique that involves systematic contraction and relaxation of specific muscle groups to reduce physical tension and promote relaxation. Diaphragmatic Breathing focuses on slow, deep breathing using the diaphragm to enhance parasympathetic nervous system activity and reduce physiological arousal.
This study will employ a randomized controlled trial design. Eligible chemotherapy patients who meet the inclusion criteria will be randomly allocated to either an intervention group or a control group. Participants in the intervention group will receive a structured program consisting of Progressive Muscle Relaxation and Diaphragmatic Breathing exercises in addition to routine medical care. Participants in the control group will receive routine medical care only.
Sleep outcomes will be evaluated before and after the intervention period using the Pittsburgh Sleep Quality Index, sleep diary recordings, and wearable sleep monitoring devices. The findings of this study may provide evidence regarding the effectiveness of combined relaxation and breathing techniques as supportive interventions for improving sleep quality among patients undergoing chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups. The intervention group will receive Progressive Muscle Relaxation and Diaphragmatic Breathing exercises in addition to routine treatment , while the control group will receive routine care alone. Outcomes will be assessed before and after the intervention period.
| Arm | Type | Receives |
|---|---|---|
| PMR and Diaphragmatic Breathing Group | Experimental | Behavioral: Progressive Muscle Relaxation and Diaphragmatic BreathingParticipants will receive Progressive Muscle Relaxation and Diaphragmatic Breathing exercises in addition to traditional medical treatment during the study period. |
| Traditional treatment group | No intervention | –Participants will receive traditional medical treatment only without the relaxation and breathing intervention program. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- • Aged between 40-60 years
Key exclusion criteria (6 listed)
- Diagnosed with sleep disorders unrelated to chemotherapy (e.g., obstructive sleep apnea)
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 |
|---|---|---|
| Progressive Muscle Relaxation and Diaphragmatic BreathingParticipants will receive a structured program of Progressive Muscle Relaxation and Diaphragmatic Breathing exercises in addition to traditional treatment . The intervention is designed to promote relaxation, reduce physiological arousal, and improve sleep quality in patients undergoing chemotherapy. | Behavioural | PMR and Diaphragmatic Breathing Group |
Primary outcome
Sleep Quality
Time frame: Baseline (pre-intervention) and after 4 weeks of intervention (post-intervention)
Assessment of sleep quality using the Pittsburgh Sleep Quality Index (PSQI). The PSQI total score is measured in points and ranges from 0 to 21, with higher scores indicating poorer sleep quality. A total score greater than 5 indicates clinically significant sleep disturbance. A reduction in the PSQI score from baseline to post-intervention reflects an improvement in sleep quality. Changes in PSQI scores will be used to evaluate the effect of Progressive Muscle Relaxation and Diaphragmatic Breathing exercises on sleep disturbances in patients undergoing chemotherapy.
4 secondary outcomes
Sleep Latency
Time frame: Baseline (pre-intervention) and after 4 weeks of intervention (post-intervention)
Sleep Efficiency
Time frame: Baseline (pre-intervention) and after 4 weeks of intervention (post-intervention)
Total Sleep Time
Time frame: Baseline (pre-intervention) and after 4 weeks of intervention (post-intervention)
Number of Nocturnal Awakenings
Time frame: Baseline (pre-intervention) and after 4 weeks of intervention (post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- BackgroundMustian, K. M., et al. (2017). Treatment of sleep disturbance in cancer patients. Journal of Clinical Oncology.
- Background: PubMed 25061767Irwin MR. Why sleep is important for health: a psychoneuroimmunology perspective. Annu Rev Psychol. 2015 Jan 3;66:143-72. doi: 10.1146/annurev-psych-010213-115205. Epub 2014 Jul 21.
- Background: PubMed 16624497Jerath R, Edry JW, Barnes VA, Jerath V. Physiology of long pranayamic breathing: neural respiratory elements may provide a mechanism that explains how slow deep breathing shifts the autonomic nervous system. Med Hypotheses. 2006;67(3):566-71. doi: 10.1016/j.mehy.2006.02.042. Epub 2006 Apr 18.
- BackgroundJacobson, E. (1938). Progressive Relaxation. University of Chicago Press.
- General information on cancer-related sleep disturbances.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to confidentiality considerations and to ensure protection of patient privacy. The data will be used solely for the purposes of this academic study and will not be made publicly available.
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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.
Haidy Ashem, Professor principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Muscle Relaxation and Diaphragmatic Breathing in people with Sleep Disturbance and Sleep Disorders, run by Cairo 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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 10 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haidy Ashem, Professor (01099765185, haidyjojo.hn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: Baseline (pre-intervention) and after 4 weeks of intervention (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07639710, which also lists 4 linked publications.
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 10 Jun 2026.