Rheumatoid Arthritis - RheumatismNCT05888220
Application of Warm Water and Warm Salt Water to Patients With Rheumatoid Arthritis
A study testing warm salt water bath in people with Rheumatoid Arthritis - Rheumatism, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis - Rheumatism
- What is being tested?
- warm salt water bath
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jan 2022to 10 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- - 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,
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
S.B.Ü Gülhane Training and Education Hospital
Ankara, 06010
About this study
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,
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.
Read the 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
- Being tested
- warm salt water bath
- Keywords
- pain,fatigue,sleep,functional status,rheumatoid arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
warm salt water bathOther
Also called warm 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Visual Analog Scale
Pain is among the main reasons for rheumatoid arthritis patients to apply to the hospital and seek medical care.
Measured: 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.
Measured: 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
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.
Measured: 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
The quality of life of patients with rheumatoid arthritis is adversely affected by the symptoms they experience.
Measured: It was applied just before the interventions and six weeks after interventions. Change from baseline health assessment scores at the end of sixth week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start4 Jan 2022
- Primary completion31 Oct 2022
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid Arthritis - RheumatismStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, OKŞAN AKTAŞ, Hacettepe University
- Investigators
- Sevgisun Kapucu, Prof., Study chair, Hacettepe University Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888220
- Sponsor's protocol ID
- 2021/56
- Status last verified
- May 2023
- First submitted
- 28 Apr 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40790488
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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,
- ClinicalTrials.gov ID
- NCT05888220
- Acronym / sponsor ID
- 2021/56
- Conditions
- Rheumatoid Arthritis - Rheumatism
- Keywords
- pain,fatigue,sleep,functional status,rheumatoid arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| warm salt water group | Experimental | Other: warm salt water bathThe 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. |
| warm water group | Experimental | Other: warm salt water bathThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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),
Key exclusion criteria (11 listed)
- - 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| warm salt water bathAlso: warm water bathWarm water and warm salt water bath were applied to the hands and feet of the patients. It is a non-pharmacological intervention | Other | warm salt water group, warm water group |
Primary outcome
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.
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.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Derived from this study: PubMed 40790488Aktas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevgisun Kapucu, Prof. study chair
Hacettepe University Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing warm salt water bath in people with Rheumatoid Arthritis - Rheumatism, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05888220, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.