The Effect of Pranayama Breathıng Exercıses on Paın, Anxıety,aAnd Sleep Qualıty in Indıvıduals wıth Fıbromyalgıa

NCT07328763 | Active Not Recruiting

• 1 other identifier: 2025/224
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Individuals diagnosed with fibromyalgia syndrome have a low quality of life due to factors such as pain, sleep problems, high anxiety, depression and low self-esteem, difficulty performing daily living activities, and inhibited socialization (García-Martínez et al., 2012; Sieczkowska et al., 2020). Nurses apply care with a holistic approach philosophy that includes supportive, preventive, therapeutic, and rehabilitative aspects to promote and maintain health. Pranayama is an effective, non-invasive, cost-effective, and easily applicable approach that can be implemented within the framework of holistic care (İlter \& Ovayolu, 2021). It is the nurse's responsibility to provide care and create a comfortable environment for patients, improving their quality of life (Aktaş \& İlgin, 2023). In this regard, during the application and teaching of breathing exercises, nurses should carefully assess patients' belief in these exercises. They should plan with the patient the appropriate time, duration, and environment for breathing exercises and be able to evaluate the results (ÖZ, 2020). Studies evaluating the results of applying pranayama to individuals with fibromyalgia are limited in the literature. Therefore, it is thought that pranayama could greatly facilitate and provide concrete data on improving the quality of life for individuals with fibromyalgia by reducing pain, sleep problems, anxiety, and improving functionality.

Conditions

Patients Diagnosed With Fibromyalgia Syndrome

Keywords

Fibromyalgia, Nursing, Pranayama, Quality of Life, Anxiety, Sleep Quality

Outcome Measures

Primary Outcomes (4)

• Visual Analog Scale (VAS)

  To indicate the severity of your pain, place an (I) mark on one of the lines below. 0 points: no pain, 1-2 points: very mild pain, 3-4 points: mild pain, 5-6 points: moderate pain, 7-8 points: severe pain, 9-10 points: very severe pain.

  6 Weeks

• Pittsburgh Sleep Quality Index (PSQI)

  questions only relate to habits from the past month.

  6 Weeks

• Beck Anxiety Scale (BAS)

  Some symptoms that people experience when they are anxious or worried.

  6 Weeks

• Fibromyalgia Impact Questionnaire (FIQ)

  Severity of fibromyalgia symptoms

  6 Weeks

Study Arms (2)

Control

NO INTERVENTION

Patients in the control group will be given an appointment schedule containing their scheduled interview dates.

Pranayama

EXPERIMENTAL

Pranayama breathing exercises will be taught online for 20 minutes, twice a week for 6 weeks.

Other: Pranayama breathing exercises

Interventions

Pranayama breathing exercises OTHER

Step 1: Normal breathing, focusing on the breath Step 2: Sun Breath (Surya Prana) Step 3: Alternate Nose Breathing (Nadi Shodhana) Step 4: Ocean Breath (Ujiayi) Step 5: Normal breathing, focusing on the breath

Pranayama

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 18 and over,
• having experienced pain for at least three months,
• diagnosed with fibromyalgia by a physician according to the ACR 2016
• romyalgia diagnostic criteria,
• having a PUKI score of five or higher,
• having a VAS pain score of one or higher,
• having no communication problems,
• and not being pregnant.

You may not qualify if:

• Individuals with a history of respiratory diseases such as malignancy or tuberculosis,
• those with a psychiatric diagnosis,
• those with nasal obstruction due to septal deviation,
• and those who have previously participated in a similar breathing exercise program will be excluded from the study.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Samsun Physical Medicine and Rehabilitation Hospital

Samsun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Officials

• Aybike KÖSE

  Samsun Provincial Health Directorate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Nurse (RN)

Model Details: The study used block randomization. Block randomization was performed by an independent researcher. In the randomization, two different groups were coded with different letters (A, B) and blocks were formed. Then, random numbers were assigned to the blocks using a computer. The letters assigned in the randomization were written in sealed envelopes and kept. After identifying patients who met the inclusion criteria, informed consent was obtained, pre-tests were administered, and then the independent researcher was contacted to determine which group the patient belonged to. Patients diagnosed with fibromyalgia who present to the polyclinic will be referred to the researcher. Before starting the study, informed consent will be obtained from the participating patients. Patients in the control group will be given an appointment schedule including their scheduled dates. Patients in the experimental group will have an exercise plan developed and will be given an appointment schedule including

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 9, 2026
• Study Start: June 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: January 30, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)