The Effect of Cold Application in Patients With Rheumatoid Arthritis

April 23, 2026 updated by: Betül ERTEN, Saglik Bilimleri Universitesi

The Effect of Cold Application on Pain, Disease Activity and Quality of Life in Patients With Rheumatoid Arthritis

The aim of this thesis is to examine the effects of cold application on pain, disease activity, and quality of life in patients with Rheumatoid Arthritis.

Currently, non-pharmacological interventions, such as cold therapy, are utilized less frequently than pharmacological treatments for the management of pain in inflamed joints. Cold application is anticipated to alleviate pain and consequently enhance patients' quality of life. This study seeks to improve quality of life by reducing pain in patients with Rheumatoid Arthritis. Given its simplicity, ease of application, and low cost, this intervention may be recommended as a pain management strategy both for patients and for nurses working in clinical settings. Furthermore, the study aims to contribute to the existing literature on the subject.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

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 (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Faculty of health sciences Saglik Bilimleri 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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Having been diagnosed with rheumatoid arthritis at least 6 months ago,
  • No problems with speaking, communicating, hearing, or understanding,
  • Able to understand and speak Turkish,
  • Experiencing pain.

Exclusion Criteria

  • Patients who are in remission
  • Individuals of foreign nationality
  • People with psychiatric or mental illnesses
  • Patients who do not consent to participate in the study or who withdraw at any stage of the study

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cold Application Group
Patients will be instructed to apply cold therapy three times daily for 15 minutes each session over a period of three weeks. Patients will report their daily cold application to the researcher via text message. For those unable to provide updates via text, the researcher will follow up daily by phone to monitor adherence to the intervention.
Behavioral: Cold Application
Patients will be instructed to apply cold therapy three times daily for 15 minutes each session over a period of three weeks. Patients will report their daily cold application to the researcher via text message. For those unable to provide updates via text, the researcher will follow up daily by phone to monitor adherence to the intervention.
No Intervention: Control Group
This patient group will undergo follow-up assessment after a three-week period during which no intervention will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rheumatoi Arthritis Disease Activity Index-5
Time Frame: 3 weeks
The Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5) is a patient-reported outcome measure designed to assess disease activity in individuals with rheumatoid arthritis
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Short Form Health Survery- SF-36
Time Frame: 3 weeks
The Short Form-36 (SF-36) is a widely used generic health-related quality of life (HRQoL) questionnaire designed to assess overall physical and mental well-being. It is a self-administered instrument that evaluates health status across multiple dimensions, making it suitable for clinical practice, research, and population health surveys.
3 weeks

Collaborators and Investigators

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

Sponsor

Saglik Bilimleri Universitesi

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)

October 14, 2024

Primary Completion (Actual)

January 30, 2026

Study Completion (Actual)

March 29, 2026

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBU-SBF-BE-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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