NCT06318455

Brief Summary

Women receiving chemotherapy have poor sleep quality and high stress levels. With a method such as breathing exercise, which can be applied at any time without side effects, positive improvements in women's sleep and stress levels can be recorded.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

March 7, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

March 12, 2024

Last Update Submit

March 4, 2025

Conditions

Women Receiving ChemotherapyPoor Quality SleepBreast Cancer Stage II

Keywords

chemotherapy, sleep quality, breathing exercise

Outcome Measures

Primary Outcomes (1)

  • anxiety state scale

    anxiety state scale point min:0 max:63)

    12 weeks

Study Arms (2)

breathing exercise group

EXPERIMENTAL

breathing exercise group: make breathing exercise for 12 weeks

Other: Breathing exercise

control group

NO INTERVENTION

control group: continue standart treartment

Interventions

Breathing exerciseOTHER

For 12 weeks they will do kumbaka breathing exercise for 5 minutes twice a day in the morning and evening

Also known as: breathing and control group
breathing exercise group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsthe study will be conducted in women with breast cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women receiving chemotherapy women with poor sleep quality 18 years of age and above women with high stress levels

You may not qualify if:

  • who do not want to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of İstanbul-cerrahpaşa (IUC)

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast NeoplasmsSleep Initiation and Maintenance Disorders

Interventions

Breathing ExercisesRespirationControl Groups

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy ModalitiesRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Gürcan Solmaz, PhD

    İstanbulUniversity-Cerrahpaşa

    STUDY CHAIR

  • Gürcan Solmaz, PhD

    İstanbul University-Cerrahpaşa

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 12, 2024

First Posted

March 19, 2024

Study Start

November 1, 2023

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

March 7, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)