The Effect of Pranayama Breathing Exercise on Fatigue in Cancer Patient Caregivers

Fatigue Clinical Trial

Official title:

Comparison of the Effect on Fatigue of the Cancer Patient Caregiver Who Applied Pranayama Breathing Exercise and no Application

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05988320
• Other study ID #: SANKOU-HEM-ZD-02
• Status: Recruiting
• Phase: N/A
• Start date: July 18, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: August 2023
• Source: Sanko University
• Contact: Zeynep DOGAN, Master
• Phone: +90507 427 49 85
• Email: zeynep.dogan[@]sanko.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 30, 2023
• Est. primary completion date: October 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Caregiver
• Fatigue

Intervention

Procedure:
• Pranayama breathing exercise
Pranayama is an important step in yoga, way of life, and is translated as "the science of breathing, breath control, willful breathing". This alternating breathing-out action also balances the sympathetic and parasympathetic nervous systems, giving the person a state of calm, providing relaxation and positively affecting fatigue. Application steps; Right hand Nasika mudra is performed. Nasika mudra is the mudra where the second and third fingers of the right hand are folded into the palm and the other fingers are exposed. Then the right nostril is closed with the first finger of the right hand. Start by breathing through the left nostril. Then the left nostril is closed with the fourth finger and the breath is held. While the left nostril is closed, the right nostril is opened and inhaled. Breathe again through

Locations

Country	Name	City	State
Turkey	Erciyes University	Kayseri	Talas

Sponsors (1)

Lead Sponsor	Collaborator
Sanko University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fatigue of cancer caregivers	Measuring the fatigue of cancer patient caregivers before and after four weeks of training	four weeks