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

NCT ID: NCT05888220

Last Updated: 2023-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-04
• Study Completion Date: 2023-01-10

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.

Conditions

Rheumatoid Arthritis - Rheumatism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

warm salt water bath

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

warm salt water bath

Intervention Type: OTHER

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Other Intervention Names

warm water bath

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,
• Patients who did not agree to participate in the study were not included in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

OKŞAN AKTAŞ

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sevgisun Kapucu, Prof.

Role: STUDY_CHAIR

Hacettepe University Faculty of Nursing

Locations

S.B.Ü Gülhane Training and Education Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 40790488 (View on PubMed)

Other Identifiers

2021/56

Identifier Type: -

Identifier Source: org_study_id