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Pranayama and Diaphragmatic Breathing Exercise Applied to Female Patients With Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pranayama
diaphragm breathing exercise
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fibromyalgia focused on measuring Fibromyalgia, Pranayama, Diaphragmatic breathing, Quality of sleep, Pain, Fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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,

Sites / Locations

  • Meltem SungurRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

pranayama

diaphragm breathing exercise group

control group

Arm Description

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.

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.

It is the group where no application has been made.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 6, 2023
Last Updated
June 13, 2023
Sponsor
Inonu University
Collaborators
Kilis 7 Aralik University
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1. Study Identification

Unique Protocol Identification Number
NCT05840939
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2022 (Actual)
Primary Completion Date
December 24, 2022 (Actual)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University
Collaborators
Kilis 7 Aralik University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Pranayama, Diaphragmatic breathing, Quality of sleep, Pain, Fatigue

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study was conducted as a single-blind randomized controlled study with pretest-posttest.
Masking
Participant
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pranayama
Arm Type
Experimental
Arm Description
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.
Arm Title
diaphragm breathing exercise group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
It is the group where no application has been made.
Intervention Type
Behavioral
Intervention Name(s)
Pranayama
Intervention Description
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
Intervention Name(s)
diaphragm breathing exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
"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
[Time Frame: 6 weeks]

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Being female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Şevki Hakan EREN
Phone
0342 360 60 60
Email
hstpersonel@gantep.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MELTEM SUNGUR
Organizational Affiliation
Kilis 7 Aralik University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meltem Sungur
City
Şahinbey
State/Province
Gaziantep
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MELTEM SUNGUR
Phone
05436178066

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Can be reviewed by other researchers after the study has been published.
IPD Sharing Time Frame
data will be shared as long as they are published
IPD Sharing Access Criteria
publication page

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Pranayama and Diaphragmatic Breathing Exercise Applied to Female Patients With Fibromyalgia

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