Hepatitis BNCT06864923
The Effect of Hot Foot Bath on Sleep Quality and Fatigue
A study testing Hot foot bath application group in people with Hepatitis B, run by Uludag University.
Trial summary
This study will be conducted to investigate the effects of hot foot baths on patients' sleep quality and fatigue severity levels.The study will be conducted in the Gastroenterology clinic of a university hospital in Türkiye. The research sample will consist of 60 adult patients. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Hot foot bath application group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 5 Mar 2025to 5 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being over the age of 18,
- having no disorder which could affect pain perception,
- having no communication problem, and voluntarily agreeing to participate in the research,
- Having been admitted to the clinic at least 24 hours ago,
- Not having a diagnosed sleep disorder,
- Not having a psychiatric disorder requiring treatment,
Show all 9Show fewer
- Not having a problem with vital signs before the application,
- Not using narcotic drugs in the last 4 hours,
- Not eating two hours before going to bed at night
Who cannot join
- being under the age of 18
- not being conscious, refusing to participate in the research or opting to leave the study at any point,
- Having a problem with vital signs before the application,
- Having a diagnosed sleep disorder.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigation of the Effect of Hot Foot Bath on Sleep Quality and Fatigue
This study will be conducted to investigate the effects of hot foot baths on patients' sleep quality and fatigue severity levels.The study will be conducted in the Gastroenterology clinic of a university hospital in Türkiye. The research sample will consist of 60 adult patients. Patients will be randomly divided into two groups: the intervention and control groups. The intervention group will receive hot foot baths for three consecutive nights starting from the second day of hospitalization. The foot bath will be applied one hour before the patient goes to bed at night. The foot tub will be filled with hot water to approximately 20 cm above the patient's ankle and the temperature of the water will be measured with a water thermometer. The temperature of the water will be kept stable at 41-42°C. This application will be done for 20 minutes. The sleep and fatigue levels of the patients will be measured with measurement tools in the morning (3 times) following each application. No application will be applied to the control group, and sleep and fatigue levels will be measured in a similar manner to the measurement tools applied to the intervention group and the application days.
- Conditions
- Hepatitis B
- Being tested
- Hot foot bath application group
- Keywords
- fatigue, sleep quality, foot bath
- Medical subject headings
- Hepatitis B, Fatigue, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot foot bath application groupOther
The intervention group will receive hot foot baths for three consecutive nights starting from the second day of hospitalization. The foot bath will be applied one hour before the patient goes to bed at night. The foot tub will be filled with hot water to approximately 20 cm above the patient's ankle and the temperature of the water will be measured with a water thermometer. The temperature of the water will be kept stable at 41-42°C. This application will be done for 20 minutes. The sleep and fatigue levels of the patients will be measured with measurement tools in the morning (3 times) following each application.
| Study group | Role | What they receive |
|---|---|---|
| Hot foot bath application group | Experimental | Not described Receives: Other: Hot foot bath application group |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
fatigue severity in score (0-10)
Brief Fatigue Inventory: Scoring ranges from "0" to "10", with "0" indicating no effect and "10" indicating the highest level of effect. The general fatigue score is calculated by dividing the total score of items 1, 2 and 3 by 3, and the effect score of fatigue on daily living activities is calculated by dividing the total score of items 4a, 4b, 4c, 4d, 4e and 4f by 6. A score of "0" obtained from the KYE indicates no fatigue, "1-3" indicates low fatigue, "4-6" indicates moderate fatigue, "7-9" indicates high fatigue and "10" indicates the highest level of effe
Measured: 4 months
Sleep Quality in score
Sleep Quality Scale: It consists of a total of 18 items. It includes items related to the sleep process and sleep satisfaction.
Measured: 4 months
Secondary outcomes (1)
weight
weight in kilograms
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start5 Mar 2025 (estimated)
- Primary completion5 Jun 2025 (estimated)
- Study completion5 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- 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
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Yilmaz, PhD, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864923
- Sponsor's protocol ID
- 2023-28/12
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Hot Foot Bath on Sleep Quality and Fatigue
- ClinicalTrials.gov ID
- NCT06864923
- Acronym / sponsor ID
- 2023-28/12
- Conditions
- Hepatitis B
- Keywords
- fatigue, sleep quality, foot bath
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 5 Mar 2025 (estimated)
- Primary completion
- 5 Jun 2025 (estimated)
- Study completion
- 5 Jun 2025 (estimated)
- First posted
- 7 Mar 2025 (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 study will be conducted to investigate the effects of hot foot baths on patients' sleep quality and fatigue severity levels.The study will be conducted in the Gastroenterology clinic of a university hospital in Türkiye. The research sample will consist of 60 adult patients. Patients will be randomly divided into two groups: the intervention and control groups. The intervention group will receive hot foot baths for three consecutive nights starting from the second day of hospitalization. The foot bath will be applied one hour before the patient goes to bed at night. The foot tub will be filled with hot water to approximately 20 cm above the patient's ankle and the temperature of the water will be measured with a water thermometer. The temperature of the water will be kept stable at 41-42°C. This application will be done for 20 minutes. The sleep and fatigue levels of the patients will be measured with measurement tools in the morning (3 times) following each application. No application will be applied to the control group, and sleep and fatigue levels will be measured in a similar manner to the measurement tools applied to the intervention group and the application days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hot foot bath application group | Experimental | Other: Hot foot bath application group |
| Control group | No intervention | – |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- being over the age of 18,
- having no disorder which could affect pain perception,
- having no communication problem, and voluntarily agreeing to participate in the research,
- Having been admitted to the clinic at least 24 hours ago,
- Not having a diagnosed sleep disorder,
Key exclusion criteria (4 listed)
- being under the age of 18
- not being conscious, refusing to participate in the research or opting to leave the study at any point,
- Having a problem with vital signs before the application,
- Having a diagnosed sleep disorder.
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 |
|---|---|---|
| Hot foot bath application groupThe intervention group will receive hot foot baths for three consecutive nights starting from the second day of hospitalization. The foot bath will be applied one hour before the patient goes to bed at night. The foot tub will be filled with hot water to approximately 20 cm above the patient's ankle and the temperature of the water will be measured with a water thermometer. The temperature of the water will be kept stable at 41-42°C. This application will be done for 20 minutes. The sleep and fatigue levels of the patients will be measured with measurement tools in the morning (3 times) following each application. | Other | Hot foot bath application group |
Primary outcome
fatigue severity in score (0-10)
Time frame: 4 months
Brief Fatigue Inventory: Scoring ranges from "0" to "10", with "0" indicating no effect and "10" indicating the highest level of effect. The general fatigue score is calculated by dividing the total score of items 1, 2 and 3 by 3, and the effect score of fatigue on daily living activities is calculated by dividing the total score of items 4a, 4b, 4c, 4d, 4e and 4f by 6. A score of "0" obtained from the KYE indicates no fatigue, "1-3" indicates low fatigue, "4-6" indicates moderate fatigue, "7-9" indicates high fatigue and "10" indicates the highest level of effe
Sleep Quality in score
Time frame: 4 months
Sleep Quality Scale: It consists of a total of 18 items. It includes items related to the sleep process and sleep satisfaction.
1 secondary outcome
weight
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Hepatitis B
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
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.
Questions about this trial
What is this clinical trial studying?
A study testing Hot foot bath application group in people with Hepatitis B, run by Uludag University.
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 9 inclusion and 4 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: opening soon, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dilek Yılmaz, PhD (+902242942454, dilekk@uludag.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fatigue severity in score (0-10) (time frame: 4 months). 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?
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 11 Mar 2025.