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Using Pranayama and Deep Breathing Exercises to Reduce Cancer-Related Fatigue and Insomnia During Radiotherapy

Primary Purpose

Breast Cancer, Fatigue, Insomnia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
breathing exercise
Sponsored by
KTO Karatay University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast cancer, Fatigue, Insomnia, Pranayama, Radiotherapy, Breathing exercises

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • over the age of 18 years,
  • who underwent breast resection or modified radical mastectomy,
  • were planned for radiotherapy for the chest wall/breast and lymphatic area, had Stage II-III breast cancer according to the TNM (Tumor diameter, Node, Metastasis) classification system,
  • had a hemoglobin (HgB) level of 10 gm/dL and above,
  • scored 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) Performance Scale
  • who agreed to participate in the study were included in the sample.

Exclusion Criteria:

  • having any problems that would prevent communication,
  • having stage IV breast cancer according to the TNM classification system,
  • using opioids or sedating drugs,
  • scoring above 1 on the ECOG Performance Scale,
  • having psychiatric illnesses,
  • taking yoga/pranayama/deep breathing exercise lessons before or having done these exercises prior to diagnosis,
  • having recurrent breast cancer
  • being unable to perform the exercises due to physical inability/respiratory distress.

Sites / Locations

  • Ankara Yildirim Beyazıt University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Pranayama

Deep breathing exercise

Arm Description

Usual care

Pranayama breathing exercise

Deep breathing exercise

Outcomes

Primary Outcome Measures

Fatigue Visual Analog Scale (VAS) Score
This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.
Fatigue Visual Analog Scale (VAS) Score
This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.
Fatigue Visual Analog Scale (VAS) Score
This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.
Fatigue Visual Analog Scale (VAS) Score
This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.
Fatigue Visual Analog Scale (VAS) Score
This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.
Fatigue Visual Analog Scale (VAS) Score
This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.
İnsomnia Visual Analog Scale (VAS) Score
The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.
İnsomnia Visual Analog Scale (VAS) Score
The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.
İnsomnia Visual Analog Scale (VAS) Score
The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.
İnsomnia Visual Analog Scale (VAS) Score
The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.
İnsomnia Visual Analog Scale (VAS) Score
The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.
İnsomnia Visual Analog Scale (VAS) Score
The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.
Piper Fatique Scale
Piper Fatique Scale scale consisted of 22 items and evaluated the patient's subjective fatigue perception with four subdimensions. Each item was scored between 0 and 10. A high score obtained from the scale indicated a high level of perceived fatigue.
Piper Fatique Scale
Piper Fatique Scale consisted of 22 items and evaluated the patient's subjective fatigue perception with four subdimensions. Each item was scored between 0 and 10. A high score obtained from the scale indicated a high level of perceived fatigue.
Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index is a self-report-based screening and evaluation tool that provides detailed information on sleep quality and type and severity of sleep disorder in the past month.The total PSQI score could vary from 0 to 21. A PSQI score over 5 points indicated that the person suffered serious problems in at least two areas related to sleep or that they suffered mild to moderate problems in more than three areas
Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index is a self-report-based screening and evaluation tool that provides detailed information on sleep quality and type and severity of sleep disorder in the past month.The total PSQI score could vary from 0 to 21. A PSQI score over 5 points indicated that the person suffered serious problems in at least two areas related to sleep or that they suffered mild to moderate problems in more than three areas

Secondary Outcome Measures

Full Information

First Posted
June 12, 2020
Last Updated
June 18, 2020
Sponsor
KTO Karatay University
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1. Study Identification

Unique Protocol Identification Number
NCT04441827
Brief Title
Using Pranayama and Deep Breathing Exercises to Reduce Cancer-Related Fatigue and Insomnia During Radiotherapy
Official Title
The Study Aims to Evaluate Effectiveness of Pranayama and Deep Breathing Exercise in Reducing Fatigue and Insomnia in Patients Receiving Radiotherapy Due to Breast Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
May 15, 2018 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KTO Karatay University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study aims to evaluate the effectiveness of pranayama and deep breathing exercise in reducing fatigue and insomnia in patients receiving radiotherapy due to breast cancer. The randomized controlled interventional study was carried out with 60 patients divided into the pranayama (20), deep breathing exercise (20) and control group (20). Data were collected with the Piper Fatigue Scale (PFS), the Pittsburgh Sleep Quality Index (PSQI) and the Visual Analog Scale (VAS).
Detailed Description
Study sample The study population consisted of patients diagnosed with breast cancer, who received radiotherapy in the radiation oncology unit of a hospital in Ankara, between June 01, 2017 and January 31, 2019. At least three additional volunteers (16%) for each group were added, considering monitoring and data loss during the follow-up. Thus, the number of subjects was determined as 63 individuals (21 for each group). Of the 63 patients, one wanted to interrupt the treatment and two did not want to continue in the study, hence the study was concluded with 20 patients in each group (60 patients). Instruments Fatigue Visual Analog Scale (VAS) Score Piper Fatigue Scale (PFS) Insomnia Visual Analog Scale (VAS) Score Pittsburgh Sleep Quality Index (PSQI) Questionnaire on Patients' Opinions of the Exercises Patients in the pranayama, deep breathing exercise and control group were evaluated six times in terms of fatigue and insomnia VAS scores. PFS and PSQI were evaluated once prior to and after the 25-day session of radiotherapy treatment. Interventions Protocols for pranayama and deep breathing exercises were prepared Pranayama and Deep Breathing Exercise Groups: The patients were taught pranayama and deep breathing exercises by the researcher before the radiotherapy started. The patients were observed performing these exercises for 10 minutes after each radiotherapy session (25 days) accompanied by the researcher in a quiet room within the radiotherapy unit containing two couches and a chair. Control Group: The patients in this group did not receive any intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Fatigue, Insomnia
Keywords
Breast cancer, Fatigue, Insomnia, Pranayama, Radiotherapy, Breathing exercises

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Arm Title
Pranayama
Arm Type
Experimental
Arm Description
Pranayama breathing exercise
Arm Title
Deep breathing exercise
Arm Type
Experimental
Arm Description
Deep breathing exercise
Intervention Type
Other
Intervention Name(s)
breathing exercise
Intervention Description
Pranayama Group Breathing Exercises Step One:Focusing on breathing (1 minute) Step Two: Alternative nasal breathing (3 minutes) Step Three: Refreshing breath (3 minutes) Step Four: Humming bee breath (2 minutes) Step Five: Focusing on breathing (1 minute)
Primary Outcome Measure Information:
Title
Fatigue Visual Analog Scale (VAS) Score
Description
This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.
Time Frame
Before radiotherapy
Title
Fatigue Visual Analog Scale (VAS) Score
Description
This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.
Time Frame
First week
Title
Fatigue Visual Analog Scale (VAS) Score
Description
This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.
Time Frame
Second week
Title
Fatigue Visual Analog Scale (VAS) Score
Description
This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.
Time Frame
Third week
Title
Fatigue Visual Analog Scale (VAS) Score
Description
This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.
Time Frame
Fourth week
Title
Fatigue Visual Analog Scale (VAS) Score
Description
This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.
Time Frame
Fifth week
Title
İnsomnia Visual Analog Scale (VAS) Score
Description
The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.
Time Frame
Before radiotherapy
Title
İnsomnia Visual Analog Scale (VAS) Score
Description
The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.
Time Frame
First week
Title
İnsomnia Visual Analog Scale (VAS) Score
Description
The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.
Time Frame
Second week
Title
İnsomnia Visual Analog Scale (VAS) Score
Description
The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.
Time Frame
Third week
Title
İnsomnia Visual Analog Scale (VAS) Score
Description
The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.
Time Frame
Fourth week
Title
İnsomnia Visual Analog Scale (VAS) Score
Description
The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.
Time Frame
Fifth week
Title
Piper Fatique Scale
Description
Piper Fatique Scale scale consisted of 22 items and evaluated the patient's subjective fatigue perception with four subdimensions. Each item was scored between 0 and 10. A high score obtained from the scale indicated a high level of perceived fatigue.
Time Frame
Before radiotherapy
Title
Piper Fatique Scale
Description
Piper Fatique Scale consisted of 22 items and evaluated the patient's subjective fatigue perception with four subdimensions. Each item was scored between 0 and 10. A high score obtained from the scale indicated a high level of perceived fatigue.
Time Frame
Fifth week
Title
Pittsburgh Sleep Quality Index
Description
Pittsburgh Sleep Quality Index is a self-report-based screening and evaluation tool that provides detailed information on sleep quality and type and severity of sleep disorder in the past month.The total PSQI score could vary from 0 to 21. A PSQI score over 5 points indicated that the person suffered serious problems in at least two areas related to sleep or that they suffered mild to moderate problems in more than three areas
Time Frame
Before radiotherapy
Title
Pittsburgh Sleep Quality Index
Description
Pittsburgh Sleep Quality Index is a self-report-based screening and evaluation tool that provides detailed information on sleep quality and type and severity of sleep disorder in the past month.The total PSQI score could vary from 0 to 21. A PSQI score over 5 points indicated that the person suffered serious problems in at least two areas related to sleep or that they suffered mild to moderate problems in more than three areas
Time Frame
Fifth week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: over the age of 18 years, who underwent breast resection or modified radical mastectomy, were planned for radiotherapy for the chest wall/breast and lymphatic area, had Stage II-III breast cancer according to the TNM (Tumor diameter, Node, Metastasis) classification system, had a hemoglobin (HgB) level of 10 gm/dL and above, scored 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) Performance Scale who agreed to participate in the study were included in the sample. Exclusion Criteria: having any problems that would prevent communication, having stage IV breast cancer according to the TNM classification system, using opioids or sedating drugs, scoring above 1 on the ECOG Performance Scale, having psychiatric illnesses, taking yoga/pranayama/deep breathing exercise lessons before or having done these exercises prior to diagnosis, having recurrent breast cancer being unable to perform the exercises due to physical inability/respiratory distress.
Facility Information:
Facility Name
Ankara Yildirim Beyazıt University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Using Pranayama and Deep Breathing Exercises to Reduce Cancer-Related Fatigue and Insomnia During Radiotherapy

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