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Clinical Trials/NCT05888220
NCT05888220
Completed
Not Applicable

The Effect Of Warm Salt Water and Warm Water Bath Applied to Hands and Feet of Patients With Rheumatoid Arthritis on Pain, Fatigue, Sleep Quality and Functional Capacity,

Hacettepe University1 site in 1 country54 target enrollmentJanuary 4, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rheumatoid Arthritis - Rheumatism
Sponsor
Hacettepe University
Enrollment
54
Locations
1
Primary Endpoint
Pain Visual Analog Scale
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This pretest-posttest randomized controlled study aimed to determine the effect of warm salt water and warm water bath applied to the hands and feet on pain, fatigue, sleep quality, and functional capacity in patients with rheumatoid arthritis.

The study consisted of three groups. These groups consisted of two intervention groups and one control group. As a result of the power analysis, it was determined that 54 people should be reached. Visual Analog Scale, Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire, Pittsburgh Sleep Quality Index, and Health Assessment Questionnaire were used in the study. Patients in intervention groups applied a 41°C warm salt and warm water bath three times a week for six weeks in line with the training given. The patients in the control group did not undergo any intervention other than routine treatment and care.

Detailed Description

The study was conducted at Gulhane Training and Research Hospital Rheumatology Polyclinic, in Turkey. The sample of the study consisted of 54 patients. Eighteen patients in the warm saltwater group were trained using the video demonstration method to make the intervention. Eighteen patients in the lukewarm water group were trained using the video demonstration method to make the intervention. Eighteen patients in the control group were not given any training other than their routine treatment and care. Each patient's pain, fatigue, sleep quality, and functional capacities were measured 24 hours before the intervention. The study lasted six weeks for each patient. The patients in the intervention group performed their interventions three times a week, every other day. The patients were checked by calling every week by phone. Pain, fatigue, sleep quality, and functional capacity of each patient were measured within one week at the latest, after the end of the practices.

Registry
clinicaltrials.gov
Start Date
January 4, 2022
End Date
January 10, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

OKŞAN AKTAŞ

Principal Investigator

Hacettepe University

Eligibility Criteria

Inclusion Criteria

  • 18 years or older,
  • Followed up with a diagnosis of RA for at least 1 year,
  • VAS pain score of 5 and above,
  • Volunteer to participate in the research,
  • Disease activity score is low-moderate (DAS28 \< 5.1),
  • Patients receiving active treatment (corticosteroid, non-steroidal anti-inflammatory, disease-modifying antirheumatic drugs) for the last 3 months were included in the study.

Exclusion Criteria

  • - Comorbidity (active malignancy, heart failure or symptomatic ischemic heart disease, severe lung disease, neurologic disease that impairs mobility, uncontrolled thyroid disease, diabetes mellitus)
  • Recent injury or major surgery (within 6 months prior to enrollment)
  • E-joint replacement surgery is planned,
  • Acute infection, fever or vascular disease in the lower and upper extremities,
  • The integrity of the skin on the hands and feet is impaired,
  • Participating in a regular physical therapy or exercise program,
  • pregnant,
  • Diagnosed with sleep apnea
  • VAS pain score below 5,
  • Disease activity score ≥ 5.1,

Outcomes

Primary Outcomes

Pain Visual Analog Scale

Time Frame: It was applied just before the interventions and six weeks after interventions. Change from baseline pain scores at the end of sixth week.

Pain is among the main reasons for rheumatoid arthritis patients to apply to the hospital and seek medical care.

Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire

Time Frame: It was applied just before the interventions and six weeks after the interventions. Change from baseline fatigue scores at the end of sixth week.

Fatigue is one of the most common symptoms experienced by rheumatoid arthritis patients and this symptom affects most patients.

Secondary Outcomes

  • Pittsburgh Sleep Quality Index(It was applied just before the interventions and six weeks after interventions. Change from baseline sleep quality scores at the end of sixth week.)
  • Health Assessment Questionnaire(It was applied just before the interventions and six weeks after interventions. Change from baseline health assessment scores at the end of sixth week.)

Study Sites (1)

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