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

NCT05888220 | Completed

• 1 other identifier: 2021/56
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis - Rheumatism

Keywords

pain,fatigue,sleep,functional status,rheumatoid arthritis

Outcome Measures

Primary Outcomes (2)

• Pain Visual Analog Scale

  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

  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 Outcomes (2)

• 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 Arms (3)

warm salt water group

EXPERIMENTAL

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 group

EXPERIMENTAL

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

control group

NO INTERVENTION

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.

Interventions

warm salt water bath OTHER

Warm water and warm salt water bath were applied to the hands and feet of the patients. It is a non-pharmacological intervention

Also known as: warm water bath

warm salt water group; warm water group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

S.B.Ü Gülhane Training and Education Hospital

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (1)

• Aktas O, Donmez AA, Kapucu S, Cinar M. The effect of warm saltwater and warm water baths on pain, fatigue, sleep quality, and functional capacity in patients with rheumatoid arthritis: a randomized controlled study✰. BMC Complement Med Ther. 2025 Aug 12;25(1):302. doi: 10.1186/s12906-025-05050-2.

  PMID: 40790488 DERIVED

Study Officials

• Sevgisun Kapucu, Prof.

  Hacettepe University Faculty of Nursing

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: June 5, 2023
• Study Start: January 4, 2022
• Primary Completion: October 31, 2022
• Study Completion: January 10, 2023
• Last Updated: June 5, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)