The Effect of Breathing Exercise on Chemotherapy-induced Nausea and Vomiting in With Autologous Hematopoietic Stem Cell Transplantation Patients
NCT ID: NCT05311371
Last Updated: 2024-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
70 participants
INTERVENTIONAL
2022-02-01
2023-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Breathing is the easiest relaxation exercise applied during the flow in everyday life and also one of the most important and essential parts of other relaxation exercise. The handbooks prepared for the patients undergoing chemotherapy recommend deep breathing exercises in order to prevent their nausea and vomiting.
The aim of this study is to determine the effect of respiratory exercise on chemotherapy-induced nausea and vomiting in patients with autologous hematopoietic stem cell transplantation.
Research Hypotheses Ho: Respiratory exercise is not effective in preventing chemotherapy-associated nausea and vomiting in autologous hematopoietic stem cell transplant patients.
H1: Respiratory exercise is effective in preventing chemotherapy-associated nausea and vomiting in autologous hematopoietic stem cell transplant patients.
In the literature, no study has been found investigating the effect of breathing exercises on chemotherapy-induced nausea and vomiting for autologous hematopoietic stem cell transplantation patients.
The aim of this study is to determine the effect of respiratory exercise on chemotherapy-induced nausea and vomiting in patients with autologous hematopoietic stem cell transplantation.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Breathing Exercise Application in Patients With Gynecological Cancer.
NCT06777225
The Effect of Breathing Exercise on Sleep and Stress Levels in Women With Breast Cancer Receiving Chemotherapy Treatment
NCT06318455
Effects of Breathing Exercises on Pain, Fatigue, and Anxiety Levels in Women Receiving Brachytherapy
NCT06613061
The Effect of Breath Exercıse and Reıkı Applıcatıon
NCT06902259
Effects of Acupressure and Aromatherapy on Nausea and Vomiting Severity, Anxiety and Comfort Level
NCT06529458
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Breathing exercise group
The researcher will collect the data using Patient Information Form, Rhodes Index of Nausea, Vomiting and Retching Scale, Patient Diary for determining the number of nausea, vomiting, and retching episodes and the hours of breathing exercise of the patient, and Daily Nutritional Consumption Amount Form through face-to-face interview technique on the first day and for 14 days.
During chemotherapy and stem cell transplantation, antiemetic treatment included in the treatment protocol will be applied to the patients.
The patients will train about the application of breathing exercise by the researcher. They will be asked to do this breathing exercise with the guideline for at least 5 min in case of sensation of nausea and vomiting for 14 days.
Breathing exercise group
The exercise was applied in accordance with the "Guideline on Breathing Exercise for Reducing Nausea and Vomiting" prepared by the researcher in accordance with the literature. In addition, the researcher has a breath coaching certificate. The guideline include the application steps of breathing exercise. First, the researcher will demonstrate to the patients the practice of breathing exercise in accordance with the guideline. In the next step, patients they will be asked to do this application on themselves. The training is planned to take about 15-20 minutes for each patient. This guide will be given to patients after the training. They will be asked to do this breathing exercise correctly and effectively in accordance with the guideline for at least 5 min in case of sensation of nausea and vomiting for 14 days. The researcher will follow up the patients for 14 days by visiting room them every day.
Control group
The researcher will collect the data using Patient Information Form, Rhodes Index of Nausea, Vomiting and Retching Scale, Patient Diary for determining the number of nausea, vomiting, and retching episodes and the hours of breathing exercise of the patient, and Daily Nutritional Consumption Amount Form through face-to-face interview technique on the first day. The researcher will continue to fill out Rhodes Index of Nausea, Vomiting and Retching Scale, Patient Diary for determining the number of nausea, vomiting, and retching episodes and the hours of breathing exercise of the patient, and Daily Nutritional Consumption Amount Form for 14 days.
During chemotherapy and stem cell transplantation, antiemetic treatment included in the treatment protocol will be applied to the patients.
Control group
No intervention
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Breathing exercise group
The exercise was applied in accordance with the "Guideline on Breathing Exercise for Reducing Nausea and Vomiting" prepared by the researcher in accordance with the literature. In addition, the researcher has a breath coaching certificate. The guideline include the application steps of breathing exercise. First, the researcher will demonstrate to the patients the practice of breathing exercise in accordance with the guideline. In the next step, patients they will be asked to do this application on themselves. The training is planned to take about 15-20 minutes for each patient. This guide will be given to patients after the training. They will be asked to do this breathing exercise correctly and effectively in accordance with the guideline for at least 5 min in case of sensation of nausea and vomiting for 14 days. The researcher will follow up the patients for 14 days by visiting room them every day.
Control group
No intervention
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Autologous hematopoietic stem cell transplantation and take high-dose chemotherapy,
* not have any communicative problems,
* not have Coronavirus disease (COVID-19) disease or respiratory disease,
* Hb value of 10 and above and
* knowing how to read, write, and speak Turkish
Exclusion Criteria
* having any communication and psychiatric problem,
* not knowing how to read, write, and speak Turkish,
* not wanting to participate in the study and have anemia.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Koc University Hospital
OTHER
Istanbul University - Cerrahpasa
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
ZELİHA GENÇ
Principal Investigator and PhD thesis student
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Koç University Hospital
Istanbul, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Cohen L, de Moor CA, Eisenberg P, Ming EE, Hu H. Chemotherapy-induced nausea and vomiting: incidence and impact on patient quality of life at community oncology settings. Support Care Cancer. 2007 May;15(5):497-503. doi: 10.1007/s00520-006-0173-z. Epub 2006 Nov 14.
Haiderali A, Menditto L, Good M, Teitelbaum A, Wegner J. Impact on daily functioning and indirect/direct costs associated with chemotherapy-induced nausea and vomiting (CINV) in a U.S. population. Support Care Cancer. 2011 Jun;19(6):843-51. doi: 10.1007/s00520-010-0915-9. Epub 2010 Jun 9.
Roila F, Molassiotis A, Herrstedt J, Aapro M, Gralla RJ, Bruera E, Clark-Snow RA, Dupuis LL, Einhorn LH, Feyer P, Hesketh PJ, Jordan K, Olver I, Rapoport BL, Roscoe J, Ruhlmann CH, Walsh D, Warr D, van der Wetering M; participants of the MASCC/ESMO Consensus Conference Copenhagen 2015. 2016 MASCC and ESMO guideline update for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting and of nausea and vomiting in advanced cancer patients. Ann Oncol. 2016 Sep;27(suppl 5):v119-v133. doi: 10.1093/annonc/mdw270. No abstract available.
Rapoport BL. Delayed Chemotherapy-Induced Nausea and Vomiting: Pathogenesis, Incidence, and Current Management. Front Pharmacol. 2017 Jan 30;8:19. doi: 10.3389/fphar.2017.00019. eCollection 2017.
Aybar DO, Kilic SP, Cinkir HY. The effect of breathing exercise on nausea, vomiting and functional status in breast cancer patients undergoing chemotherapy. Complement Ther Clin Pract. 2020 Aug;40:101213. doi: 10.1016/j.ctcp.2020.101213. Epub 2020 Jun 14.
Suryono A., Akbar F., Nugraha F.S., Armiyati Y. Combination of of deep breathing relaxation and murottal reducing post chemotherapy nausea intensity in nasopharyngeal cancer (NPC) patients, Media Keperawatan Indonesia. 2020; 3: 24-31.
Yoo HJ, Ahn SH, Kim SB, Kim WK, Han OS. Efficacy of progressive muscle relaxation training and guided imagery in reducing chemotherapy side effects in patients with breast cancer and in improving their quality of life. Support Care Cancer. 2005 Oct;13(10):826-33. doi: 10.1007/s00520-005-0806-7. Epub 2005 Apr 23.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022.065.IRB1.034
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.