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

Primary Purpose

Rheumatoid Arthritis - Rheumatism

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
warm salt water bath
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rheumatoid Arthritis - Rheumatism focused on measuring pain,fatigue,sleep,functional status,rheumatoid arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • S.B.Ü Gülhane Training and Education Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

warm salt water group

warm water group

control group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pittsburgh Sleep Quality Index
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.
Health Assessment Questionnaire
The quality of life of patients with rheumatoid arthritis is adversely affected by the symptoms they experience.

Full Information

First Posted
April 28, 2023
Last Updated
May 24, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05888220
Brief Title
Application of Warm Water and Warm Salt Water to Patients With Rheumatoid Arthritis
Official Title
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,
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 4, 2022 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
January 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis - Rheumatism
Keywords
pain,fatigue,sleep,functional status,rheumatoid arthritis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
warm salt water group
Arm Type
Experimental
Arm Description
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.
Arm Title
warm water group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
warm salt water bath
Other Intervention Name(s)
warm water bath
Intervention Description
Warm water and warm salt water bath were applied to the hands and feet of the patients. It is a non-pharmacological intervention
Primary Outcome Measure Information:
Title
Pain Visual Analog Scale
Description
Pain is among the main reasons for rheumatoid arthritis patients to apply to the hospital and seek medical care.
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.
Title
Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire
Description
Fatigue is one of the most common symptoms experienced by rheumatoid arthritis patients and this symptom affects most patients.
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.
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index
Description
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.
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.
Title
Health Assessment Questionnaire
Description
The quality of life of patients with rheumatoid arthritis is adversely affected by the symptoms they experience.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sevgisun Kapucu, Prof.
Organizational Affiliation
Hacettepe University Faculty of Nursing
Official's Role
Study Chair
Facility Information:
Facility Name
S.B.Ü Gülhane Training and Education Hospital
City
Ankara
ZIP/Postal Code
06010
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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