- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07456982
The Effect of Relaxation Breathing Exercise on Chemotherapy Induced Nausea and Vomiting
The Effect of Relaxation Breathing Exercise on Chemotherapy Induced Nausea and Vomiting in Patients With Hematological Malignancies
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kartal
-
Istanbul, Kartal, Turkey (Türkiye), 34000
- Marmara University, Mehmet Genç Complex
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control group
|
Control group does not perform relaxation breathing exercise.
They only receive standard treatment.
|
|
Experimental: Relaxation breathing exercise intervention group
|
Relaxation breathing 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from the start of the chemotherapy in the frequency and severity of nasea, vomiting and retching at 6 days.
Time Frame: From enrollment to the end of intervention 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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sıdıka Oğuz, Prof.Dr., Marmara University, Faculty of Health Sciences, Department of Medical Nursing
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Signs and Symptoms, Digestive
- Hematologic Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Hemic and Lymphatic Diseases
- Hematologic Neoplasms
- Nausea
- Vomiting
- Investigative Techniques
- Epidemiologic Research Design
- Epidemiologic Methods
- Research Design
- Methods
- Control Groups
Other Study ID Numbers
- Protocol No:09.2020.1036
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hematological Malignancies
-
Tel-Aviv Sourasky Medical CenterMeir Medical Center; Max Planck Institute for Infection BiologyUnknownPediatric Solid Malignancies | Pediatric Hematological MalignanciesIsrael
-
Donghua ZhangNot yet recruitingCD7-Positive Hematological MalignanciesChina
-
Baylor College of MedicineCenter for Cell and Gene Therapy, Baylor College of MedicineCompletedMyeloid Hematological MalignanciesUnited States
-
Centre Hospitalier Universitaire de BesanconTerminatedHematological Malignancies BFrance
-
Shanghai Chia Tai Tianqing Pharmaceutical Technology...Not yet recruitingPhase I Clinical Trial of TQB2825 Subcutaneous Injection in CD20-positive Hematological MalignanciesCD20-positive Hematological MalignanciesChina
-
AdaptimmuneTerminatedSolid and Hematological MalignanciesUnited States, Canada
-
Institute of Hematology & Blood Diseases Hospital...Juventas Cell Therapy Ltd.AvailableRelapsed and Refractory Hematological MalignanciesChina
-
Shandong UniversityJuventas Cell Therapy Ltd.UnknownRelapsed or Refractory Hematological MalignanciesChina
-
CASI Pharmaceuticals, Inc.CompletedRelapsed or Refractory Hematological MalignanciesCanada
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingRelapsed/Refractory Hematological MalignanciesChina
Clinical Trials on Relaxation breathing exercise
-
University of YalovaCompleted
-
Aysenur DostbilRecruitingHypotension | Cesarean Section | Hemodynamic Instability | Anxiety, AnticipatoryTurkey (Türkiye)
-
Istanbul Medipol University HospitalCompleted
-
Ataturk UniversityCompletedCOPD | Progressive Muscle Relaxation | Deep BreathTurkey
-
King Saud UniversityCompletedEssential HypertensionSaudi Arabia
-
Cairo UniversityCompletedDiabetes Mellitus | StressEgypt
-
Biruni UniversityCompleted
-
Palo Alto Veterans Institute for ResearchVA Palo Alto Health Care System; Brain & Behavior Research FoundationCompletedAnxiety DisordersUnited States
-
Meyer Children's Hospital IRCCSRecruitingAnxiety | Surgeries Requiring a Minimum One Day HospitalizationItaly
-
VA Office of Research and DevelopmentCompleted