The Effect of Cherry Seed Pillow on Fibromyalgia

February 11, 2024 updated by: Hasan Gerçek, HASAN GERÇEK

The Effect of Cherry Seed Pillow on Pain and Quality of Life in Patients With Fibromyalgia

In this study, the effects of 4-week Cherry seed pillow application on pain and quality of life in individuals diagnosed with fibromyalgia will be examined.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Karatay
      • Konya, Karatay, Turkey
        • KTO Karatay University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Over 18 years of age
  • Diagnosis of Fibromyalgia according to ACR classification criteria
  • Neuromuscular system examination is normal
  • Pain (vas-visual anologous scale) level of at least 5 points
  • No communication problems
  • Willingness to participate in the practice of using cherry seed cushion
  • To be capable of answering the data collection tools to be used in the research
  • Not having made hot, cold etc. applications at home

Exclusion Criteria:

  • -No diagnosis of Fibromyalgia according to ACR classification criteria
  • Normal examination of the neuromuscular system
  • Pain (vas-visual anologous scale) level between 0-5
  • Communication problems
  • Failure to accept the practice of using cherry seed cushion and failure to finish the implementation process
  • Having a musculoskeletal disorder other than fibromyalgia
  • Pregnant or lactating
  • To be capable of answering the data collection tools to be used in the research
  • Having made hot, cold etc. applications at home

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cherry seed pillow
4 Weeks, 5 days a week, 20 minutes, in addition to the physiotherapy application of the routine, a heated cherry seed pillow will be applied.
Other: Cherry seed pillow
4 Weeks, 5 days a week, in addition to the routine physiotherapy application, 20 minutes of heated cherry seed pillow will be applied to the participant's back area.
Active Comparator: Control
4 Weeks, 5 days a week, 20 minutes, in addition to the physiotherapy application of the routine, a hot-pack will be applied.
Other: Control
4 Weeks, 5 days a week, in addition to the routine physiotherapy application, 20 minutes of hotpack will be applied to the participant's back area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in pain at 4 weeks
Time Frame: Baseline and 4 weeks
he rest, activity and night pains of the participants will be evaluated with a 10 cm Visual Analog Scale before the treatment and at the end of the 4-week application. "0" means no pain, "10" means excruciating pain. Results will be recorded in cm.
Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in function at 4 weeks
Time Frame: Baseline and 4 weeks
The Fibromyalgia Impact Questionnaire will be used to assess the functioning of the participants. The questionnaire consists of 20 questions. As the score increases, the function decreases.
Baseline and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HASAN GERÇEK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2023

Primary Completion (Actual)

February 6, 2024

Study Completion (Actual)

February 10, 2024

Study Registration Dates

First Submitted

December 6, 2023

First Submitted That Met QC Criteria

December 6, 2023

First Posted (Actual)

December 14, 2023

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 11, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KaratatUH10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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