Clinical trial NCT05840939: Pranayama and Diaphragmatic Breathing Exercise Applied to Female Patients With Fibromyalgia
Official title: The Effect of Pranayama and Diaphragmatic Breathing Exercise on Sleep Quality, Pain and Fatigue Level in Female Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Pranayama
Diaphragmatic breathing
Quality of sleep
Pain
Fatigue
Lead sponsor: Inonu University
Sponsor class: OTHER
Collaborators: name: Kilis 7 Aralik University
First posted: 2023-05-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was conducted as a single-blind randomized controlled study with pretest-posttest.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Female patients diagnosed with fibromyalgia were divided into pranayama breathing exercise, diaphragm breathing exercise and control groups. The sleep quality, pain and fatigue levels of the patients in the intervention group were determined before and after the breathing exercise.

Detailed description: Aim: This study was conducted to determine the effect of pranayama and diaphragm breathing exercises applied to female patients diagnosed with fibromyalgia on sleep quality, pain and fatigue levels.

Material and Method: This study, designed as a randomized controlled and experimental study, was conducted between November 2022 and June 2023. The data of the study consisted of 100 female patients diagnosed with fibromyalgia: 32 in the pranayama group, 33 in the diaphragm breathing exercise group and 35 in the control group. As data collection tools; Patient Information Form, Visual Analog Scale, Fatigue Severity Scale and Pittsburgh Sleep Quality Scale were used. During the study, the control group received routine treatment, while the two groups in the intervention group received the following training given by the researcher; They were asked to do pranayama and diaphragm breathing exercise 3 sets a day (morning-afternoon-evening), 7 days a week for 6 weeks. At the end of this process, sleep quality, pain and fatigue levels of three groups were evaluated again.

Results: It was observed that there was no statistically significant difference between the initial pain and sleep quality total scores of three groups (p\>0.05), there was a significant difference between the groups in terms of pain, fatigue and sleep quality scores after the application (p\<0.05).

Conclusion: As a result, it was determined that breathing exercises reduced the patients' pain and fatigue levels and improved their sleep quality.

Keywords: Pain, diaphragmatic breathing, fibromyalgia, pranayama, sleep quality, fatigue

Eligibility criteria: Inclusion Criteria:

•● Being 18 years or older

* Being a female patient who has had pain for at least three months and has been diagnosed with fibromyalgia by a physician according to the ACR 2016 fibromyalgia diagnostic criteria.
* Having a PSQI score of five and above
* Complaint of fatigue and getting a score of 4 or above on the fatigue severity scale
* Pain score of one or above according to VAS
* Having no communication problems and knowing how to read, write and speak Turkish
* Not being pregnant and not breastfeeding

Exclusion Criteria:

* Having a malignancy related to the respiratory system (bronchus or lung)
* Having tuberculosis disease
* Having chest pain
* Having any psychiatric diagnosis during outpatient clinic screenings
* Having a nasal septum derivation or adenoid that will affect the ventilation process
* Having previously practiced/trained in pranayama or diaphragmatic breathing exercises

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: [Time Frame: 6 weeks]
Secondary outcomes:
Other outcomes:
Locations:
city: Şahinbey
country: Turkey
facility: Meltem Sungur
state: Gaziantep
Study officials:
affiliation: Kilis 7 Aralik University
name: MELTEM SUNGUR
role: PRINCIPAL_INVESTIGATOR
References: