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NCT Number: NCT05888220

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

S.B.Ü Gülhane Training and Education Hospital

Ankara, 06010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: warm water bath

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study 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,

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jun 5, 2023
Registry last updated
Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.