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NCT Number: NCT07639710

Effect of Progressive Muscle Relaxation and Diaphragmatic Breathing on Sleep Disturbances in Chemotherapy Patients

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.

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Key information

Conditions

Sleep Disturbance Cancer Dyssomnias Mental Disorders Neoplasms Nervous System Diseases Neurologic Manifestations Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progressive Muscle Relaxation and Diaphragmatic Breathing

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Haidy Ashem, Professor

CONTACT

[email protected]

01099765185

Nada Yousef, Lecturer

CONTACT

[email protected]

01021527586

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Progressive Muscle Relaxation and Diaphragmatic Breathing Techniques on Sleep Disturbances in Cancer Patients Undergoing Chemotherapy

Acronym: PMR & DB

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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