Clinical trial NCT04441827: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Fatigue
Insomnia
Keywords: Breast cancer
Fatigue
Insomnia
Pranayama
Radiotherapy
Breathing exercises
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Fatigue Visual Analog Scale (VAS) Score
timeFrame: Before radiotherapy
measure: Fatigue Visual Analog Scale (VAS) Score
timeFrame: First week
measure: Fatigue Visual Analog Scale (VAS) Score
timeFrame: Second week
measure: Fatigue Visual Analog Scale (VAS) Score
timeFrame: Third week
measure: Fatigue Visual Analog Scale (VAS) Score
timeFrame: Fourth week
measure: Fatigue Visual Analog Scale (VAS) Score
timeFrame: Fifth week
measure: İnsomnia Visual Analog Scale (VAS) Score
timeFrame: Before radiotherapy
measure: İnsomnia Visual Analog Scale (VAS) Score
timeFrame: First week
measure: İnsomnia Visual Analog Scale (VAS) Score
timeFrame: Second week
measure: İnsomnia Visual Analog Scale (VAS) Score
timeFrame: Third week
measure: İnsomnia Visual Analog Scale (VAS) Score
timeFrame: Fourth week
measure: İnsomnia Visual Analog Scale (VAS) Score
timeFrame: Fifth week
measure: Piper Fatique Scale
timeFrame: Before radiotherapy
measure: Piper Fatique Scale
timeFrame: Fifth week
measure: Pittsburgh Sleep Quality Index
timeFrame: Before radiotherapy
measure: Pittsburgh Sleep Quality Index
timeFrame: Fifth week
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yildirim Beyazıt University
Study officials:
References: