NCT05695274

Brief Summary

Relaxation techniques are a non-pharmacological therapy option applied to alleviate the symptoms of many different chronic diseases. It has been reported in the literature that PMR is effective on pain, fatigue and stress symptoms in fibromyalgia patients. No study has been found examining the effect of PMR on kinesiophobia and functional status in FM. This study was planned to examine the effect of progressive muscle relaxation exercises on pain, kinesiophobia and functional status in fibromyalgia patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

January 5, 2023

Last Update Submit

April 16, 2024

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (3)

  • Progressive muscle relaxation exercise changes pain

    Visual Pain Scale

    The pain scores of the patients will be measured before the PMR application and at the end of the PMR application (at the end of the 8th week) two days a week for the 8th week using the visual pain scale. The pain score is min 1 - max 10.

  • Progressive muscle relaxation exercise changes kinesiophobia

    Tampa Scale for Kinesiophobia

    The Kinesiophobia scores of patients will be measured before the PMR application and at the end of the PMR application (at the end of the 8th week) two days a week for the 8th week. A total of 17-68 points are obtained from the scale.

  • Progressive muscle relaxation exercise changes functional status

    Revised Fibromyalgia Impact Questionnaire

    The functional status scores of patients will be measured before the PMR application and at the end of the PMR application (at the end of the 8th week) two days a week for the 8th week. A high score indicates increased disability due to FM.

Study Arms (2)

Experimental group

EXPERIMENTAL

To examine the effects of progressive muscle relaxation exercises on pain, kinesiophobia and functional status in fibromyalgia patients.

Behavioral: Progressive muscle relaxation exercise

Control group

NO INTERVENTION

Control group; routine care and treatment will be applied.

Interventions

Progressive muscle relaxation exerciseBEHAVIORAL

Experimental group Fibromyalgia patients will be provided with progressive relaxation exercises twice a week. Progressive relaxation technique includes stretching and relaxing the bigmuscle groups (hands, arms, neck, shoulders, face, chest, abdomen,hip, feet andfingers) in the human body on purpose. When steps ofProgressive Relaxation Exercises are analyzed, it is observed thatlearning how to take correct and deep breaths is the most impor-tant step towards learning relaxation.

Experimental group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being older than 18 years of age
  • Having been diagnosed with fibromiyalgia for at least 6 months ago.
  • Having no mental disability

You may not qualify if:

  • Individuals receiving another complementary and integrative treatment
  • Individuals who have done progressive muscle relaxation exercise before.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cemile KÜTMEÇ YILMAZ

Merkez, Aksaray, 68100, Turkey (Türkiye)

Location

Aksaray University Health Science Faculty

Aksaray, 68100, Turkey (Türkiye)

Location

Related Publications (1)

  • Karakoyun A, Kutmec Yilmaz C, Sayin Kasar K. Are Progressive Muscle Relaxation Exercises Effective on Pain, Kinesiophobia, and Functional Status in Fibromyalgia Patients? A Randomized Controlled Trial. Res Nurs Health. 2026 Feb;49(1):9-18. doi: 10.1002/nur.70029. Epub 2025 Nov 14.

    PMID: 41235733DERIVED

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • CEMİLE KÜTMEÇ YILMAZ

    Aksaray University, Faculty of Health Science, Nursing Department, Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 5, 2023

First Posted

January 25, 2023

Study Start

November 10, 2022

Primary Completion

June 30, 2023

Study Completion

November 30, 2023

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)