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NCT Number: NCT04441827

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

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).

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Dyssomnias Fatigue Insomnia Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Yildirim Beyazıt University

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Breathing exercise

Other

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 outcomes

  1. Fatigue Visual Analog Scale (VAS) Score

    Time frame: Before radiotherapy

    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.

  2. Fatigue Visual Analog Scale (VAS) Score

    Time frame: First week

    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.

  3. Fatigue Visual Analog Scale (VAS) Score

    Time frame: Second week

    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.

  4. Fatigue Visual Analog Scale (VAS) Score

    Time frame: Third week

    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.

  5. Fatigue Visual Analog Scale (VAS) Score

    Time frame: Fourth week

    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.

  6. Fatigue Visual Analog Scale (VAS) Score

    Time frame: Fifth week

    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.

  7. İnsomnia Visual Analog Scale (VAS) Score

    Time frame: Before radiotherapy

    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.

  8. İnsomnia Visual Analog Scale (VAS) Score

    Time frame: First week

    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.

  9. İnsomnia Visual Analog Scale (VAS) Score

    Time frame: Second week

    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.

  10. İnsomnia Visual Analog Scale (VAS) Score

    Time frame: Third week

    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.

  11. İnsomnia Visual Analog Scale (VAS) Score

    Time frame: Fourth week

    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.

  12. İnsomnia Visual Analog Scale (VAS) Score

    Time frame: Fifth week

    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.

  13. Piper Fatique Scale

    Time frame: Before radiotherapy

    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.

  14. Piper Fatique Scale

    Time frame: Fifth week

    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.

  15. Pittsburgh Sleep Quality Index

    Time frame: Before radiotherapy

    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

  16. Pittsburgh Sleep Quality Index

    Time frame: Fifth week

    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

Sponsors and collaborators

Lead sponsor

KTO Karatay University

Other

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jun 22, 2020
Registry last updated
Jun 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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