An interventional study of Progressive Muscle Relaxation and Diaphragmatic Breathing in Sleep Disturbance, Sleep Disorders and Cancer, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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.
756 studies on the registry are indexed under Parasomnias; 189 are open to participants now.
This study's planned enrollment of 40 is below the median of 66 across 569 interventional studies indexed under Parasomnias.
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Aged between 40-60 years
Exclusion Criteria:
Diagnosed with sleep disorders unrelated to chemotherapy (e.g., obstructive sleep apnea)
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 traditional medical treatment only without the relaxation and breathing intervention program.
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.
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.
Time frame: Baseline (pre-intervention) and after 4 weeks of intervention (post-intervention)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (pre-intervention) and after 4 weeks of intervention (post-intervention)
Plan to share: 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.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Cairo University