Pranayama and Diaphragmatic Breathing Exercise Applied to Female Patients With Fibromyalgia

Sponsor

Inonu University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05840939

Collaborator

Kilis 7 Aralik University (Other)

105

Enrollment

Location

Arms

9.6

Anticipated Duration (Months)

10.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia	Behavioral: Pranayama Behavioral: diaphragm breathing exercise	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This study was conducted as a single-blind randomized controlled study with pretest-posttest.This study was conducted as a single-blind randomized controlled study with pretest-posttest.

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Nov 11, 2022

Actual Primary Completion Date :

Dec 24, 2022

Anticipated Study Completion Date :

Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
Experimental: 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.	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.
No Intervention: control group It is the group where no application has been made.

Arm

Intervention/Treatment

Experimental: 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.

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.

Experimental: 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.

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.

No Intervention: control group

It is the group where no application has been made.

Outcome Measures

Primary Outcome Measures

Visual Analog Scale (VAS) [[Time Frame: 6 weeks]]
"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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

18 years old and over,
Having no communication problems and speaking and understanding Turkish,
Being diagnosed with fibromyalgia
Those with a PUKI score of five or more
Having a complaint of fatigue and getting a score of 4 or higher on the fatigue severity scale,
Having a pain score above 0 according to VAS,
Not pregnant and not breastfeeding,

Exclusion Criteria:

Respiratory system (bronchi or lung) malignancy,
Having tuberculosis disease,
Having chest pain
Any psychiatric diagnosis made in outpatient screenings
Having nasal septum derivation or adenoid (adenoid) that will affect the ventilation process,