Effect of Progressive Muscle Relaxation and Diaphragmatic Breathing on Sleep Disturbances in Chemotherapy Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-60
SponsorCairo University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• 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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Progressive Muscle Relaxation and Diaphragmatic Breathing
BehavioralParticipants 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: PMR and Diaphragmatic Breathing GroupExperimental treatment 1 intervention
Group B: Traditional treatment groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov
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