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

Last updated: June 18, 2020
Sponsor: KTO Karatay University
Overall Status: Completed

Phase

N/A

Condition

Pain (Pediatric)

Insomnia

Breast Cancer

Treatment

N/A

Clinical Study ID

NCT04441827
UPDBERCRFIDR
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

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 StageII-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

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 theseexercises prior to diagnosis,

  • having recurrent breast cancer

  • being unable to perform the exercises due to physical inability/respiratory distress.

Study Design

Total Participants: 60
Study Start date:
June 01, 2017
Estimated Completion Date:
January 31, 2019

Study 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.

Connect with a study center

  • Ankara Yildirim Beyazıt University

    Ankara,
    Turkey

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.