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

KTO Karatay University

Status: Completed

Conditions: Breast Cancer; Insomnia; Fatigue

Treatments: Other: breathing exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04441827

UPDBERCRFIDR

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Control

No Intervention group

Description:

Usual care

Pranayama

Experimental group

Description:

Pranayama breathing exercise

Treatment:

Other: breathing exercise

Deep breathing exercise

Experimental group

Description:

Deep breathing exercise

Treatment:

Other: breathing exercise