Application of Warm Water and Warm Salt Water to Patients With Rheumatoid Arthritis

May 24, 2023 updated by: OKŞAN AKTAŞ, Hacettepe University

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,

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

54

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
      • Ankara, Turkey, 06010
        • S.B.Ü Gülhane Training and Education Hospital

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

Yes

Description

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,
  • Patients who did not agree to participate in the study were not included in 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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: warm salt water group
The patients were told how to prepare and apply the temperature and salt ratio of the water to be used in the hand and foot bath (280 grams of rock salt to 8 liters of water) with a demonstration method with video training. video tutorial tablet It was done in a quiet environment in the hospital, in a room with the patient and the researcher. The temperature of the water and the duration of application were determined based on research that previously examined the effectiveness of warm water and warm salt water baths in various patient groups. Bath hours were determined to be between 21:00 and 22:00 in order to prevent the patients from doing any activity after this application and to provide relaxation and rest after the bath. Starting 1 day after the training, each patient is at home for six weeks from 21:00 to He applied a warm salt water bath at 41°C for 20 minutes to his hands and feet three times a week between 21:00-22:00.
Other: warm salt water bath
Warm water and warm salt water bath were applied to the hands and feet of the patients. It is a non-pharmacological intervention
Other Names:
  • warm water bath
Experimental: warm water group
The patients were told how to prepare and apply the temperature of the water to be used in the hand and foot bath with video training and demonstration method. The video training was carried out using a tablet in a quiet environment in the hospital in a room with the patient and the researcher. The temperature of the water and the duration of application were determined based on research that previously examined the effectiveness of warm water and warm salt water baths in various patient groups. Bath hours were determined to be between 21:00 and 22:00 in order to prevent the patients from doing any activity after this application and to provide relaxation and rest after the bath. Starting 1 day after the training, each patient applied a 20-minute warm water bath at 41°C every other day, three times a week between 21:00 and 22:00 at home for six weeks, on their hands and feet.
Other: warm salt water bath
Warm water and warm salt water bath were applied to the hands and feet of the patients. It is a non-pharmacological intervention
Other Names:
  • warm water bath
No Intervention: control group
No intervention was made for the patients. Visual Analog Scale, Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire, Pittsburgh Sleep Quality Index, Health Assessment Questionnaires were re-administered at the end of the sixth week in this group.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Index
Time Frame: It was applied just before the interventions and six weeks after interventions. Change from baseline sleep quality scores at the end of sixth week.
An average of 50-70% of patients with rheumatoid arthritis complain of sleep disorders such as difficulty falling asleep, decreased sleep quality, restless sleep, night waking and Excessive daytime sleepiness.
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
Time Frame: It was applied just before the interventions and six weeks after interventions. Change from baseline health assessment scores at the end of sixth week.
The quality of life of patients with rheumatoid arthritis is adversely affected by the symptoms they experience.
It was applied just before the interventions and six weeks after interventions. Change from baseline health assessment scores at the end of sixth week.

Collaborators and Investigators

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

Sponsor

Hacettepe University

Investigators

  • Study Chair: Sevgisun Kapucu, Prof., Hacettepe University Faculty of Nursing

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)

January 4, 2022

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

January 10, 2023

Study Registration Dates

First Submitted

April 28, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/56

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.

Clinical Trials on Rheumatoid Arthritis - Rheumatism

Clinical Trials on warm salt water bath

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe