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Trial Title:
The Effect of Pranayama Breathing Exercise on Fatigue in Cancer Patient Caregivers
NCT ID:
NCT05988320
Condition:
Caregiver
Fatigue
Conditions: Official terms:
Fatigue
Conditions: Keywords:
1. cancer patient caregiver 2. pranayama 3. Fatigue
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Pranayama breathing exercise
Description:
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
Arm group label:
Experimental: Applications to the Intervention Group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Erciyes University
Address:
City:
Kayseri
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Zeynep DOĞAN
Phone:
+905074274985
Email:
zeynep.dogan@sanko.edu.tr
Start date:
July 18, 2023
Completion date:
November 30, 2023
Lead sponsor:
Agency:
Sanko University
Agency class:
Other
Source:
Sanko University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05988320