Pranayama and Diaphragmatic Breathing Exercise Applied to Female Patients With Fibromyalgia

NCT ID: NCT05840939

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-11
• Study Completion Date: 2023-06-30

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

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

pranayama

At the beginning, each patient in this group was shown one-on-one by the researcher and taught by applying them together, taking into account the application steps, how to practice pranayama. In the next step, the patients were asked to do this application themselves. Sleep quality, pain and fatigue levels of the patients were determined after 6 weeks.

Group Type: EXPERIMENTAL

Pranayama

Intervention Type: BEHAVIORAL

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 group

At the beginning, the patients in this group were shown how to do the diaphragm breathing exercise and how to do the diaphragm breathing exercise, taking into account the application steps, each patient was shown individually by the researcher and taught by applying them together. In the next step, the patients were asked to do this application themselves. Sleep quality, pain and fatigue levels of the patients were determined after 6 weeks.

Group Type: EXPERIMENTAL

diaphragm breathing exercise

Intervention Type: BEHAVIORAL

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.

control group

It is the group where no application has been made.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kilis 7 Aralik University

OTHER

Sponsor Role: collaborator

Inonu University

OTHER

Sponsor Role: lead

Responsible Party

Meltem Sungur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MELTEM SUNGUR

Role: PRINCIPAL_INVESTIGATOR

Kilis 7 Aralik University

Locations

Meltem Sungur

Şahinbey, Gaziantep, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2344633

Identifier Type: -

Identifier Source: org_study_id