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临床试验/NCT05311371
NCT05311371已完成不适用

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

Istanbul University - Cerrahpasa2 个研究点 分布在 2 个国家目标入组 70 人开始时间: 2022年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
2
主要终点
Patient Information Form

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

All of the participants were blinded to the randomization procedure.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

Breathing exercise group

Experimental

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.

干预措施: Breathing exercise group (Other)

Control group

Other

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.

干预措施: Control group (Other)

结局指标

主要结局

Patient Information Form

时间窗: Baseline

Patient 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.

次要结局

  • Rhodes Index of Nausea, Vomiting ve Retching(Baseline and 14 days)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

ZELİHA GENÇ

Principal Investigator and PhD thesis student

Istanbul University - Cerrahpasa

研究点 (2)

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