Pranayama and Diaphragmatic Breathing Exercise Applied to Female Patients With Fibromyalgia

NCT05840939 | Completed

• 1 other identifier: 2344633
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Pranayama; Diaphragmatic breathing; Quality of sleep; Pain; Fatigue

Outcome Measures

Primary Outcomes (1)

• 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]

Study Arms (3)

pranayama

EXPERIMENTAL

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

diaphragm breathing exercise group

EXPERIMENTAL

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

control group

NO INTERVENTION

It is the group where no application has been made.

Interventions

Pranayama 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.

pranayama

diaphragm breathing exercise 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.

diaphragm breathing exercise group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Being female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ● 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inonu University: lead
• Kilis 7 Aralik University: collaborator

Study Sites (1)

Meltem Sungur

Şahinbey, Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Sleep Initiation and Maintenance Disorders; Pain; Fatigue

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• MELTEM SUNGUR

  Kilis 7 Aralik University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: May 3, 2023
• Study Start: November 11, 2022
• Primary Completion: December 24, 2022
• Study Completion: June 30, 2023
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: data will be shared as long as they are published
• Access Criteria: publication page

Locations

TU (1)