Clinical trial NCT05988320: The Effect of Pranayama Breathing Exercise on Fatigue in Cancer Patient Caregivers
Official title: Comparison of the Effect on Fatigue of the Cancer Patient Caregiver Who Applied Pranayama Breathing Exercise and no Application
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Caregiver
Fatigue
Keywords: CAREGİVER
CANCER
PRANAYAMA
FATİGUE
Lead sponsor: Sanko University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The caregivers of the patients hospitalized in the medical oncology clinic of the Research Center Mehmet Kemal Dedeman Hematology - Oncology Hospital will be formed. Cancer patient caregivers who meet the inclusion criteria of the study and volunteer to participate in the study will constitute the sample of the study.It is planned to take 30 people per group and 60 people in total.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research is a randomized controlled experimental study to determine the effect of pranayama breathing exercise applied to caregivers of cancer patients on fatigue.

Detailed description: METHODST: The research will be carried out at Erciyes University Health Practice and Research Center Mehmet Kemal Dedeman Hematology - Oncology Hospital located in Kayseri city center.

Population and Sample of the Research: The population of the research will be the caregivers of the patients hospitalized in the medical oncology clinic of Erciyes University Health Practice and Research Center Mehmet Kemal Dedeman Hematology - Oncology Hospital. Cancer patient caregivers who meet the inclusion criteria of the study and volunteer to participate in the study will constitute the sample of the study.

Sample of the Research: It was calculated by performing power analysis for the sample of the research. In the article titled "Evaluation of fatigue and sleep quality of caregivers of advanced cancer patients", the minimum sample size per group was 22 when the calculation was made as alpha=0.05 and power=0.80, taking into account the pretest-posttest fatigue score averages of the caregivers. It is planned to take 30 people per group Data Collection Form and Tools: The data of the study will be collected through the Caregiver Information Form, Piper Fatigue Scale, Informed Voluntary Consent Form, Eastern Cooperative Oncology Group (for the patient) Performance Scale forms.

Data Collection: Ethics committee, institutional permission and scale usage permission were obtained for the data of the study. Intervention and control group selection in the study will be collected by minimization randomization. The data will be collected by the researcher himself by face-to-face interview method. The intervention group will be given pranayama training. The post-test will be done four weeks after both groups are pre-tested.

Pre-Test: . After informing the caregivers of cancer patients in the Medical Oncology clinic about the research and obtaining verbal and written consent from the researcher, the caregiver introduction form and Piper fatigue scale will be applied to the experimental and control groups, respectively.

Post-Test: The piper fatigue scale will be re-administered to the individuals in both groups by the same researcher four weeks after the pre-test, and one day after the pranayama breathing exercise in the control group and experimental group.

Eligibility criteria: Inclusion Criteria:

* 1. Above 18 years old 2. Able to read and write 3. Having sufficient communication skills 4. Does not have any ailment that will reduce the ability to grasp and understand 5. Giving active care to inpatients in the clinic 6. Able to use smart mobile phone 7. Caregivers who agree to participate in the study will be included in the study.

Exclusion Criteria:

- 1. Having a chronic disease 2. Caregivers using opioids or sedating drugs will not be included in the study.

3. Using integrated health practices in the treatment process 4. Patients who exercise regularly will not be included in the study.

Research Termination Criteria

Intervention Group

1. Developing health problems
2. Unwilling to continue Pranayama practice
3. Not practicing pranayama as recommended or unable to do it effectively,
4. The study will be terminated with patients who want to withdraw from the study.

Control Group

1. Developing health problems
2. The study will be terminated with patients who want to withdraw from the study.

Primary outcomes:
measure: fatigue of cancer caregivers
timeFrame: four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University
state: Talas
Study officials:
References: