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NCT Number: NCT07359326

The Effect of Cold Application 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.

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Key information

Conditions

Cold Application Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Disease Activity Immune System Diseases Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatoid Arthritis (RA Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of health sciences Saglik Bilimleri University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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