Clinical trial NCT05888220: 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
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis - Rheumatism
Keywords: pain,fatigue,sleep,functional status,rheumatoid arthritis
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Pain Visual Analog Scale
timeFrame: It was applied just before the interventions and six weeks after interventions. Change from baseline pain scores at the end of sixth week.
measure: Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire
timeFrame: 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:
measure: Pittsburgh Sleep Quality Index
timeFrame: It was applied just before the interventions and six weeks after interventions. Change from baseline sleep quality scores at the end of sixth week.
measure: Health Assessment Questionnaire
timeFrame: It was applied just before the interventions and six weeks after interventions. Change from baseline health assessment scores at the end of sixth week.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: S.B.Ü Gülhane Training and Education Hospital
Study officials:
affiliation: Hacettepe University Faculty of Nursing
name: Sevgisun Kapucu, Prof.
role: STUDY_CHAIR
References: