The Effect of Cold Application in Patients With Rheumatoid Arthritis

NCT07359326 | Active Not Recruiting

• 1 other identifier: SBU-SBF-BE-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cold Application; Pain; Disease Activity; Rheumatoid Arthritis (RA

Outcome Measures

Primary Outcomes (1)

• Rheumatoi Arthritis Disease Activity Index-5

  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 Outcomes (1)

• The Short Form Health Survery- SF-36

  3 weeks

Study Arms (2)

Cold Application Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

This patient group will undergo follow-up assessment after a three-week period during which no intervention will be administered.

Interventions

Cold Application BEHAVIORAL

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.

Cold Application Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Faculty of health sciences Saglik Bilimleri University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 2 group with conventional therapy control group

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: December 10, 2024
• Primary Completion: January 30, 2026
• Study Completion (Estimated): May 29, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)