NCT05988320

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 18, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2023

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

7 months

First QC Date

August 4, 2023

Last Update Submit

May 22, 2025

Conditions

Keywords

CAREGİVERCANCERPRANAYAMAFATİGUE

Outcome Measures

Primary Outcomes (1)

  • fatigue of cancer caregivers

    Measuring the fatigue of cancer patient caregivers before and after four weeks of training

    four weeks

Study Arms (2)

Experimental: Applications to the Intervention Group

EXPERIMENTAL

Pranayama breathing will be performed by the caregivers of cancer patients in the Medical Oncology clinic for a total of 4 weeks, covering 15-20 minutes every day, for a total of 4 weeks. information will be given about the benefits and benefits, and any questions will be answered. The application steps will be repeated both by explaining and showing, until the caregiver learns, and if there are any points that they cannot do, they will be corrected. When the caregivers are observed to perform the application fully, they will be asked to do the pranayama breathing exercise every day for 4 weeks and will provide the effectiveness and continuity of the application by providing the same researcher 3 days a week (Tuesday, Thursday, Saturday) with a smartphone WhatsApp video call.

Procedure: Pranayama breathing exercise

Applications to the Control Group

NO INTERVENTION

Only the pre-test will be applied to the caregivers of cancer patients in the Medical Oncology clinic in the control group. After the caregiver introduction form and Piper fatigue scale application, no breathing exercises will be performed. Individuals will continue their daily lives. Four weeks later the Piper fatigue scale will be administered again. After the Piper fatigue scale is applied, pranayama breathing exercise training will be given to all control group patients and they will be applied for 2 sessions.

Interventions

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

Experimental: Applications to the Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.

You may not qualify if:

  • \- 1. Having a chronic disease 2. Caregivers using opioids or sedating drugs will not be included in the study.
  • \. 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
  • Developing health problems
  • Unwilling to continue Pranayama practice
  • Not practicing pranayama as recommended or unable to do it effectively,
  • The study will be terminated with patients who want to withdraw from the study.
  • Control Group
  • Developing health problems
  • The study will be terminated with patients who want to withdraw from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Kayseri, Talas, Turkey (Türkiye)

Location

MeSH Terms

Conditions

FatigueNeoplasms

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 4, 2023

First Posted

August 14, 2023

Study Start

March 18, 2023

Primary Completion

October 20, 2023

Study Completion

November 10, 2023

Last Updated

May 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

We plan to share it after it is ready for publication.

Locations