Pranayama and Diaphragmatic Breathing Exercise Applied to Female Patients With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

The Effect of Pranayama and Diaphragmatic Breathing Exercise on Sleep Quality, Pain and Fatigue Level in Female Patients With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05840939
• Other study ID #: 2344633
• Status: Completed
• Phase: N/A
• Start date: November 11, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2024
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 30, 2023
• Est. primary completion date: December 24, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• Pranayama
Pranayama, one of the practices of yoga, is a Sanskrit word consisting of a combination of two words, a technique of rhythmic, controlled breathing. So "prana" means life breath/life energy and "ayama" means expansion/regulation/control. Pranayama helps to improve lung capacity, heart and respiratory functions, nervous and hormonal systems, as well as mental activity.
• diaphragm breathing exercise
Diaphragmatic breathing is also known as deep breathing or slow abdominal breathing. This breathing exercise uses the diaphragm muscle. The diaphragm is the muscle under the lungs that supports the lungs in up and down breathing.

Locations

Country	Name	City	State
Turkey	Meltem Sungur	Sahinbey	Gaziantep

Sponsors (2)

Lead Sponsor	Collaborator
Inonu University	Kilis 7 Aralik University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS)	"0" indicates no pain and "10" indicates the most severe level of pain. On the scale, <3 mild pain, 3-6 moderate pain, >6 severe pain were specified.	[Time Frame: 6 weeks]