NCT07639710

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

1 month

First QC Date

May 30, 2026

Last Update Submit

June 6, 2026

Conditions

Sleep DisturbanceSleep DisordersCancer

Keywords

ChemotherapySleep DisturbanceSleep QualityProgressive Muscle RelaxationDiaphragmatic BreathingRelaxation TherapyCancer PatientsSleep DiaryPSQIWristband Monitor

Outcome Measures

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.

    Baseline (pre-intervention) and after 4 weeks of intervention (post-intervention)

Secondary Outcomes (4)

  • Sleep Latency

    Baseline (pre-intervention) and after 4 weeks of intervention (post-intervention)

  • Sleep Efficiency

    Baseline (pre-intervention) and after 4 weeks of intervention (post-intervention)

  • Total Sleep Time

    Baseline (pre-intervention) and after 4 weeks of intervention (post-intervention)

  • Number of Nocturnal Awakenings

    Baseline (pre-intervention) and after 4 weeks of intervention (post-intervention)

Study Arms (2)

PMR and Diaphragmatic Breathing Group

EXPERIMENTAL

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

Traditional treatment group

NO INTERVENTION

Participants will receive traditional medical treatment only without the relaxation and breathing intervention program.

Interventions

Progressive Muscle Relaxation and Diaphragmatic BreathingBEHAVIORAL

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.

PMR and Diaphragmatic Breathing Group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical TherapY

Giza, Egypt, 12613, Egypt

Location

Related Publications (4)

  • Mustian, K. M., et al. (2017). Treatment of sleep disturbance in cancer patients. Journal of Clinical Oncology.

    BACKGROUND

  • 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: 25061767BACKGROUND

  • 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: 16624497BACKGROUND

  • Jacobson, E. (1938). Progressive Relaxation. University of Chicago Press.

    BACKGROUND

Related Links

MeSH Terms

Conditions

ParasomniasSleep Wake DisordersNeoplasmsSleep Initiation and Maintenance Disorders

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Nervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomnias

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Haidy Ashem, Professor

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haidy Ashem, Professor

CONTACT

01099765185haidyjojo.hn@gmail.com

Nada Yousef, Lecturer

CONTACT

01021527586dr.nada123.ny@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 30, 2026

First Posted

June 10, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.

Locations

EG(1)