Cancer, Sleep Disorders, Sleep Disturbance
Conditions
Keywords
Chemotherapy, Sleep Disturbance, Sleep Quality, Progressive Muscle Relaxation, Diaphragmatic Breathing, Relaxation Therapy, Cancer Patients, Sleep Diary, PSQI, Wristband Monitor
Brief summary
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
BEHAVIORALProgressive 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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomly assigned to one of two parallel groups. The intervention group will receive Progressive Muscle Relaxation and Diaphragmatic Breathing exercises in addition to routine treatment , while the control group will receive routine care alone. Outcomes will be assessed before and after the intervention period.
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality | 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
| Measure | Time frame | Description |
|---|---|---|
| Sleep Latency | 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. |
| Sleep Efficiency | 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. |
| Total Sleep Time | 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. |
| Number of Nocturnal Awakenings | 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. |
Countries
Egypt
Contacts
CONTACTHaidy Ashem, Professor
CONTACTNada Yousef, Lecturer
PRINCIPAL_INVESTIGATORHaidy Ashem, Professor
Cairo University
Outcome results
None listed