The Effect of Relaxation Breathing Exercise on Chemothera... | NCT07456982

Studies
The Effect of Relaxation Breathing Exercise on Chemotherapy Induced Nausea and Vomiting

NCT07456982

Sponsor

Marmara University

Status

Active, not recruiting

Last Update Posted

Mar 9, 2026Actual

Enrollment

68Actual

Phase

Not Applicable

Conditions

Nausea and Vomiting Chemotherapy-Induced
Hematological Malignancies

Interventions

Relaxation breathing exercise
Control group

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2024Actual

Primary Completion Date

Sep 30, 2025Actual

Completion Date

Mar 2026Estimated

First Submitted Date

Feb 26, 2026

First Submission Date that Met QC Criteria

Mar 6, 2026

First Posted Date

Mar 9, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2026

Last Update Posted Date

Mar 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The Effect of Relaxation Breathing Exercise on Chemotherapy Induced Nausea and Vomiting in Patients With Hematological Malignancies ABSTRACT

Background:

Chemotherapy is widely used in the treatment of hematological malignancies despite it has important and difficult side effects in patients. Chemotherapy induced nausea and vomiting are among the most common side effects in patients and antiemetic drugs may not be always curative.

Purpose:

This research aimed to determine the effectiveness of relaxation breathing exercise on managing chemotherapy induced nausea and vomiting in patients with hematological malignancies undergoing chemotherapy.

Method:

A randomized controlled trial design was conducted with a total of selected sixty eight patients with hematological malignancies (34 intervention and 34 control participants) undergoing chemotherapy hospitalized in the hematology clinic of a Training and Research Hospital. The intervention group implemented relaxation breathing exercise three times a day with a standard treatment protocol and the control group only received routine drug treatment for chemotherapy induced nausea and vomiting. Nausea and vomiting were assessed by filling Rhodes Index of Nausea Vomiting and Retching (RINVR) for the first six days after the start of the chemotherapy.

Results:

Data collection process ended. Data analysis process is in progress.

Conclusion:

In this study the effectiveness of relaxation breathing exercise on chemotherapy related nausea and vomiting will be examined in patients with hematological malignancies.

Keywords: Relaxation breathing exercise; Hematological malignancies; Chemotherapy; Nausea and vomiting

Detailed Description

The research was conducted in the hematology clinics of a university training and research hospital in Istanbul, Turkey. Hospitalized patients with hematological malignancies who underwent chemotherapy were included in the research. Hematology patients apply to the hematology polyclinics in the hospital and then patients who are diagnosed with hematological malignancies such as leukemia, lymphoma or multiple myelome and will receive chemotherapy are hospitalized. The researcher planned to help patients to cope with nausea and vomiting while they were receiving chemotherapy in this study. Before the chemotherapy had been started, the relaxation breathing exercise training was provided to the hospitalized patients in their rooms who agreed to participate in the study. After training a guidebook about relaxation breathing exercise was given to the patients so that they would not forget how to implement the intervention

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

68Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Relaxation breathing exercise intervention group	Experimental		Behavioral: Relaxation breathing exercise
Control group	Experimental		Behavioral: Control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Relaxation breathing exercise	Behavioral	Relaxation breathing exercise: Preliminary exercise: Participants lie comfortably on their backs in the bed and focus on the lower abdomen. They place their left ankles over their right knees and then place their right ankles over their left knees. They draw both knees toward their abdomens. Relaxation breathing: Participants relax while breathing deeply through their noses and letting them out through their mouths slowly. They count to four and breathe in deeply, they hold their breathe while counting to four, and breathe out while counting to eight. Ending exercise: Participants stretch their arms and legs and then loosen them. They relax the muscles concerned with their faces, shoulders and eyebrows by keeping their mind clear.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from the start of the chemotherapy in the frequency and severity of nasea, vomiting and retching at 6 days.	Zero is equivalent to no nausea, no vomiting and no retching and 4 indicates the worst and unbearable nausea, vomiting and retching	From enrollment to the end of intervention at 6 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 18 years or over with hematological malignancies
Undergoing chemotherapy
Not having any communication problems (able to read, write and speak Turkish.

Exclusion Criteria:

Having psychiatric and mental problems
Receiving radiotherapy concurrent with chemotherapy, 3) Having respiratory distress
Having central nervous system involvement
Having Grade 3 or Grade 4 nausea and vomiting.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sıdıka Oğuz, Prof.Dr.	Marmara University, Faculty of Health Sciences, Department of Medical Nursing	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Marmara University, Mehmet Genç Complex		Istanbul	Kartal	34000	Turkey (Türkiye)

Label	URL
International journal of clinical trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

IPD used in the results

Types

Study Protocol

Time Frame

Beginning 3 months and ending 1 year after the publication of results

Access Criteria

Types of analyses that qualify for data sharing and the statistical methods for those analyses.

URL

https://www.researchgate.net

Condition Browse Module

MeSH Terms

ID	Term
D009325	Nausea
D019337	Hematologic Neoplasms
D014839	Vomiting

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D035061	Control Groups

Ancestor Terms

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

Relaxation breathing exercise: 1.Preliminary exercise Participants lie comfortably on their backs in the bed and focus on the lower abdomen. They place their left ankles over their right knees and then place their right ankles over their left knees. They draw both knees toward their abdomens. 2. Relaxation breathing Participants relax while breathing deeply through their noses and letting them out through their mouths slowly. They count to four and breathe in deeply, they hold their breathe while counting to four, and breathe out while counting to eight. 3. Ending exercise Participants stretch their arms and legs and then loosen them. They relax the muscles concerned with their faces, shoulders and eyebrows by keeping their mind clear.