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

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Sleep Quality [Time frame: Baseline (pre-intervention) and after 4 weeks of intervention (post-intervention)]

Secondary outcome measures (4)

• 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Faculty of Physical TherapY — Giza

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. PMID 25061767
• Jerath 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. PMID 16624497
• Jacobson, E. (1938). Progressive Relaxation. University of Chicago Press.

Identifiers

NCT: NCT07639710 · PMR-DB-2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗