Effect of Progressive Muscle Relaxation and Diaphragmatic Breathing on Sleep Disturbances in Chemotherapy Patients (PMR & DB)

June 6, 2026 updated by: Ashraf Said Ahmed Abdelrahman, Cairo University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
    • Egypt
      • Giza, Egypt, Egypt, 12613
        • Faculty of physical therapy
        • Contact:
        • Contact:
        • Principal Investigator:
          • Haidy Nady Ashem, Prof.Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PMR and Diaphragmatic Breathing Group
Participants will receive Progressive Muscle Relaxation and Diaphragmatic Breathing exercises in addition to traditional medical treatment during the study period.
Behavioral: Progressive Muscle Relaxation and Diaphragmatic Breathing
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.
No Intervention: Traditional treatment group
Participants will receive traditional medical treatment only without the relaxation and breathing intervention program.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (pre-intervention) and after 4 weeks of intervention (post-intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleep Latency
Time Frame: Baseline (pre-intervention) and after 4 weeks of intervention (post-intervention)
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.
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)
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.
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)
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.
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)
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.
Baseline (pre-intervention) and after 4 weeks of intervention (post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Haidy Ashem, Professor, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PMR-DB-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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