Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-31 @ 12:32 AM
Study NCT ID:
NCT06902259
Status:
COMPLETED
Last Update Posted:
2025-03-30
First Post:
2025-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Breath Exercıse and Reıkı Applıcatıon
Sponsor:
Aslıhan ÖZTÜRK ÇETİN
Organization:
Study Overview
Official Title:
The Effect of Breath Exercıse and Reıkı Applıcatıon on Tıredness and Nausea and Vomiting Management in Oncology Patıents; Randomısed Controlled Study
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Reiki App
Brief Summary:
: This randomised controlled trial was conducted to investigate the effects of breathing exercise and reiki on fatigue and nausea and vomiting symptoms in oncology patients. Data were collected between 1 December 2023 and 30 May 2024, just before the patients started chemotherapy treatment, using data collection forms with a face-to-face interview method of approximately 30 minutes. Since it was thought that there might be case losses during the study, it was decided to take 20 patients for both groups.
Detailed Description:
The study was conducted with cancer patients receiving treatment in the outpatient chemotherapy unit of a university hospital between 1 December 2024 and 30 May 2024.The population of the study was 600 cancer patients receiving chemotherapy in the Outpatient Chemotherapy Unit of a university hospital. The sample consisted of patients who applied to the Medical Oncology Outpatient Clinic for treatment between 1 December 2023 and 30 May 2024, who accepted to participate in the study and met the inclusion criteria. Power analysis was performed to determine the sample size. The power of the study was calculated with the G Power 3.1 programme. Accordingly, it was determined that there should be at least 18 patients in each group. Since it was thought that there might be case losses during the study, it was decided to take 20 patients for both groups. Sixty patients, including 20 patients in each group, who met the inclusion criteria were identified. The details of the study were explained to the patients and their consent was obtained. In order to minimise selection bias, a simple random sampling method, the random numbers table, was used and patients were assigned to groups as 20 reiki group, 20 breathing exercise group and 20 control group.Patients who volunteered to participate in the study, were diagnosed with cancer, had symptoms of nausea-vomiting and fatigue, were literate, could communicate, did not have a diagnosis of mental or psychiatric illness, were not hearing or visually impaired, were 18 years of age or older, and were not receiving antiemetic treatment.
Exclusion criteria: Patients with any other disease related to the gastrointestinal system, any other disease or condition that would prevent them from performing the exercises to be performed for the study.
Before starting the study, approval was obtained from the Bakırçay University Non-Interventional Clinical Research Ethics Committee of a state university (25.10.2023/Decision no: 1259). Institutional permission was obtained from the hospital where the study was conducted. In order to use the Hirai Cancer Fatigue Scale in the study, permission to use the scale was obtained from the author via e-mail. Verbal and written informed consent was obtained from all participants. The study was conducted according to the principles of the Helsinki Declaration of Human Rights.The data obtained in the study were analysed using SPSS (Statistical Package for Social Sciences) for Windows 22.0 software. Number, percentage, mean, standard deviation were used as descriptive statistical methods in the evaluation of the data. Differences between the rates of categorical variables in independent groups were analysed by Chi-Square tests. Kurtosis and Skewness values were analysed to determine whether the research variables showed normal distribution.
In the related literature, the results of kurtosis and skewness values of the variables between +1.5 and -1.5, +2.0 and -2.0 are accepted as normal distribution. Since it was determined that the variables were normally distributed, parametric methods were used to analyse the data \[15,16\]. One way Anova test was used to compare quantitative continuous data between groups. Scheffe test was used as a complementary post-hoc analysis to determine the differences after the Anova test. Repeated measures ANOVA test and complementary Bonferroni test were used for the comparison of intra-group measurements.
Exclusion criteria: Patients with any other disease related to the gastrointestinal system, any other disease or condition that would prevent them from performing the exercises to be performed for the study.
Before starting the study, approval was obtained from the Bakırçay University Non-Interventional Clinical Research Ethics Committee of a state university (25.10.2023/Decision no: 1259). Institutional permission was obtained from the hospital where the study was conducted. In order to use the Hirai Cancer Fatigue Scale in the study, permission to use the scale was obtained from the author via e-mail. Verbal and written informed consent was obtained from all participants. The study was conducted according to the principles of the Helsinki Declaration of Human Rights.The data obtained in the study were analysed using SPSS (Statistical Package for Social Sciences) for Windows 22.0 software. Number, percentage, mean, standard deviation were used as descriptive statistical methods in the evaluation of the data. Differences between the rates of categorical variables in independent groups were analysed by Chi-Square tests. Kurtosis and Skewness values were analysed to determine whether the research variables showed normal distribution.
In the related literature, the results of kurtosis and skewness values of the variables between +1.5 and -1.5, +2.0 and -2.0 are accepted as normal distribution. Since it was determined that the variables were normally distributed, parametric methods were used to analyse the data \[15,16\]. One way Anova test was used to compare quantitative continuous data between groups. Scheffe test was used as a complementary post-hoc analysis to determine the differences after the Anova test. Repeated measures ANOVA test and complementary Bonferroni test were used for the comparison of intra-group measurements.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: