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

NCT07456982 | Active Not Recruiting

• 1 other identifier: Protocol No:09.2020.1036
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Conditions

Nausea and Vomiting Chemotherapy-Induced; Hematological Malignancies

Keywords

Relaxation breathing exercise; Chemotherapy; Nausea and vomiting

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Relaxation breathing exercise intervention group

EXPERIMENTAL

Behavioral: Relaxation breathing exercise

Control group

EXPERIMENTAL

Behavioral: Control group

Interventions

Relaxation breathing exercise BEHAVIORAL

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.

Relaxation breathing exercise intervention group

Control group BEHAVIORAL

Control group does not perform relaxation breathing exercise. They only receive standard treatment.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University, Mehmet Genç Complex

Istanbul, Kartal, 34000, Turkey (Türkiye)

Location

Related Links

• International journal of clinical trials

MeSH Terms

Conditions

Nausea; Hematologic Neoplasms; Vomiting

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Sıdıka Oğuz, Prof.Dr.

  Marmara University, Faculty of Health Sciences, Department of Medical Nursing

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 9, 2026
• Study Start: January 30, 2024
• Primary Completion: September 30, 2025
• Study Completion: March 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

TU (1)