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The Effect of Breathing Exercise on Chemotherapy-induced Nausea and Vomiting in With Autologous Hematopoietic Stem Cell Transplantation Patients

The Effect of Breathing Exercise on Chemotherapy-induced Nausea and Vomiting in With Autologous Hematopoietic Stem Cell Transplantation Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05311371
Enrollment
70
Registered
2022-04-05
Start date
2022-02-01
Completion date
2023-03-01
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy-induced Nausea and Vomiting

Keywords

Nausea, Vomiting, Breathing exercise, Autologous Hematopoietic Stem Cell Transplantation, Chemotherapy

Brief summary

Nausea and vomiting are serious problems in patients undergoing autologous stem cell transplantation. It is stated that the incidence of acute and delayed nausea and vomiting is more than 50%, even if the patient has been given antiemetic prophylaxis during the treatment process. 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.

Interventions

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.

OTHERControl group

No intervention

Sponsors

Koc University Hospital
CollaboratorOTHER
Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

All of the participants were blinded to the randomization procedure.

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Least 18-years-old, * 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

* have respiratory disease and Coronavirus disease (COVID-19), * 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.

Design outcomes

Primary

MeasureTime frameDescription
Patient Information FormBaselinePatient Information Form is a form prepared to determine the sociodemographic and disease-related characteristics of the patients. Sociodemographic characteristics of patient are composed of height, age, weight, educational status, social security, occupation, marital status, nutritional habits, smoking and alcohol use. Patient Information Form have general information about the patients such as diagnosis, duration, stage, and metastasis status of the disease, antiemetic drugs and treatment history. Disease history of cancer is , nausea-vomiting complaints before chemotherapy, the presence of any non-pharmacological method used to reduce nausea and vomiting induced by chemotherapy drugs.

Secondary

MeasureTime frameDescription
Rhodes Index of Nausea, Vomiting ve RetchingBaseline and 14 daysResponses to each item are classified by using expressions appropriate to the item and scoring the severity of the nausea-vomiting-retching experience from 0 to 4. There are eight items in this scale that evaluate the experience, frequency and distress of nausea-vomiting and retching. The increase in score reflects worsening of the complaint experienced.

Other

MeasureTime frameDescription
Daily Nutritional Consumption Amount FormBaseline and 14 daysThe amount of consumption of the patient in the morning, lunch, evening and snacks will be recorded before the treatment and throughout the study. The patient's antiemetic treatment, enteral and parenteral nutrition will be recorded daily in the follow-up form.
Patient Nausea And Vomiting Episode Follow-Up FormBaseline and 14 daysThis follow-up chart was created by the researcher in order to evaluate the severity and episode of nausea and vomiting symptom during chemotherapy treatment and post-transplantation in patients with autologous hematopoietic stem cell transplantation. The scale consists of a 100 mm/10 cm long horizontal line. On the left end of the line, there is 0 No nausea statement, while on the right end there is 10 Nausea is very severe statement. The patient will be asked to mark the point on the line that will accurately reflect his or her nausea state. In addition, the patient will be asked to write down the number of nausea and vomiting numerically.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026