ComfortNCT05759169
The Effect of Foot Bath on Comfort, Fatigue, and Dialysis Symptoms
A study testing Foot Bath Tub in people with Comfort and Fatigue, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effect of warm water foot baths on comfort, fatigue, and dialysis symptoms in patients undergoing hemodialysis. This study was conducted as a randomized controlled trial. Data were collected with a total of 58 patients,31 in the intervention group and 27 in the placebo group. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Comfort, Fatigue, Symptoms and Signs
- What is being tested?
- Foot Bath Tub
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 1 Oct 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old,
- For patients over 65 years of age, the standardized Mini-mental Test (SMMT) value is 24 points or higher,
- Without pregnancy,
- With at least 6 months in HD units and 3 sessions per week,
- Continuing dialysis treatment in the same institution,
- No change in the foot bath treatment process and during the research process,
- Individuals who understand and communicate in Turkish have been investigated
Who cannot join
- Any psychiatric illness,
- Patients with neurovascular complications, advanced diabetes Mellitus,
- Patients with disease and treatment that trigger fatigue (advanced COPD, cancer, chemotherapy, and radiotherapy patients),
- With open wounds, neuropathy, etc., lower leg problems, which will prevent hot water treatment,
- Patients with peripheral vascular diseases in feet and legs,
- Also, patients with sensory deficits and foot ulcers,
- Patients using any complementary and integral treatment method during research,
- Patients with a standardized Mini-mental Test (SMMT) value of 23 points and less than 65 years old have been excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Foot Bath Applied to Patients Receiving Hemodialysis Treatment on Comfort, Fatigue, and Dialysis Symptoms
This study aimed to evaluate the effect of warm water foot baths on comfort, fatigue, and dialysis symptoms in patients undergoing hemodialysis.
This study was conducted as a randomized controlled trial. Data were collected with a total of 58 patients,31 in the intervention group and 27 in the placebo group. The data in the study is collected using the intervention and control group informed volunteer Form, Patient Demonstration Form, foot Bath Application Monitoring Chart, fatigue VAS Scale Form, dialysis Symptom Index, and Hemodialysis Comfort Scale.
Read the detailed description
After obtaining the necessary permissions for the work to be performed, the researcher explained the purpose of working, and the researcher took the purpose of the work. The voluntary consent of the individuals was provided in verbal and written writing.
The researcher discussed the health team in dialysis centers to ensure that the study was carried out systematically and regularly, providing information on the purpose of the study. The forms to be applied to patients are filled by the researcher using the method of a face-to-face interview and the records obtained from the patient files.
Procedures administered to control groups:
Patients in the control group have been informed about the voluntary Form, Patient Demonstration Form, fatigue VAS Scale Form, dialysis Symptom Index, and Hemodialysis Comfort Scale performed by the researcher in person. At this stage, no attempt was made to the control group at the end of the fourth week; during the last hemodialysis session, the researcher, with the fatigue VAS Scale Form, the dialysis Symptom Index and the Hemodialysis Comfort Scale face-to-face, treated the patients.
Procedures administered to intervention groups:
In line with the literature and expert opinions, each dialysis application has been applied to individuals for 30 minutes for the first 30 minutes of 4 weeks, with a 40-43°C hot water-filled foot wash tub, placing both feet of the individual (Afrasiabifar et al., 2022; Kim et al., 2021 Shafeik et al., 2018). The researcher implemented the voluntary consent Form, Patient Demonstration Form, foot Bath Application Monitoring Chart, fatigue VAS Scale Form, dialysis Symptom Index and Hemodialysis Comfort Scale in person. At the end of the fourth week, the researcher refilled the foot Bath Application Monitoring Chart, the fatigue VAS Scale Form, the dialysis Symptom Index, and the Hemodialysis Comfort Scale. A total of 12 sessions have been performed in the foot bath, including during each dialysis treatment for 4 weeks.
- Conditions
- Comfort, Fatigue, Symptoms and Signs
- Being tested
- Foot Bath Tub
- Keywords
- comfort, fatigue,, foot bath, hemodialysis, nursing
- Medical subject headings
- Fatigue, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot Bath TubOther
A foot bath is generally a form of rest and care where feet are put in water. Feet are body areas where fatigue is most felt as organs that carry the body's total weight. This study uses a specially designed foot bath bath bath bath to give the patients in the experimental group foot bath. The cuvette has four-stage water heating (35-45°C). It has a magnetic field and operates at 390 Watts. It has a splash guard. The sole features non-slip rubber feet. It has a heat shield feature because it has a double wall construction for heat isolation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | In line with the literature and expert opinions, each dialysis application has been applied to individuals for 30 minutes for the first 30 minutes of 4 weeks, with a 40-43°C hot water-filled foot wash tub, placing both feet of the individual (Afrasiabifar et al., 2022; Kim et al., 2021 Shafeik et al., 2018). The researcher implemented the voluntary consent Form, Patient Demonstration Form, foot Bath Application Monitoring Chart, fatigue VAS Scale Form, dialysis Symptom Index and Hemodialysis Comfort Scale in person. At the end of the fourth week, the researcher refilled the foot Bath Application Monitoring Chart, the fatigue VAS Scale Form, the dialysis Symptom Index, and the Hemodialysis Comfort Scale. A total of 12 sessions have been performed in the foot bath, including during each dialysis treatment for 4 weeks. Receives: Other: Foot Bath Tub |
| Control | No intervention | Patients in the control group have been informed about the voluntary Form, Patient Demonstration Form, fatigue VAS Scale Form, dialysis Symptom Index, and Hemodialysis Comfort Scale performed by the researcher in person. At this stage, no attempt was made to the control group at the end of the fourth week; during the last hemodialysis session, the researcher, with the fatigue VAS Scale Form, the dialysis Symptom Index and the Hemodialysis Comfort Scale face-to-face, treated the patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue VAS Scale Form
The rating of fatigue levels has been expressed to patients that there is no fatigue for 0 points. In comparison, 10 points indicate fatigue is very severe and are questioned how many points they have given to patients for fatigue levels.
Measured: One mounth. Fatigue levels are at the end of the process and 4 before the application begins. During the last hemodialysis session of the week, fatigue was evaluated by the VAS Scale Form.
Dialysis Symptom Index
DSI contains 30 symptoms that define a specific physical or emotional symptom. Symptoms in the last seven days have been answered as yes-no, and no indicates no symptoms, and yes, that symptom has occurred. If the patient's response is yes, how much the symptom affects is evaluated by a five-type Likert scale. 1 = none, 5 = too many ratings are made. Total scale points are collected. This value varies between 0 and 150. The total scores received show an increase in the effect of the symptom mentioned as approaching 150.
Measured: One mounth. In the first week of the trial and 4 weeks later
Hemodialysis Comfort Scale
Falcon Orak and Ark. Hemodialysis Comfort Scale (HCS), developed in 2017, with validity reliability, is a reliable scale used to assess the comfort of patients who have had hemodialysis treatment for at least six months. The hemodialysis Comfort Scale is a five-type liquid scale and consists of 9 substances and 2 sub-dimensions. T HCS can score at least 9.00 points and up to 45.00 points; 3.00 points can be achieved at least 15.00 points maximum, relax Alt-size; at least 7.00 points and up to 30.00 points can be obtained from the bottom dimension that is defeated. The increase in the value obtained indicates the level of comfort.
Measured: One mounth. In the first week of the trial and 4 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start1 May 2022
- Primary completion1 Jul 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComfortStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Single group
- Model description
- This study was done in a randomized controlled experimental research pattern to determine the effect of the foot bath applied in the last 30 minutes of dialysis treatment on comfort, fatigue and dialysis symptoms for hemodialysis patients.
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevil Şahin, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759169
- Sponsor's protocol ID
- 2021/4587
- Status last verified
- Mar 2023
- First submitted
- 24 Jan 2023
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Foot Bath Applied to Patients Receiving Hemodialysis Treatment on Comfort, Fatigue, and Dialysis Symptoms
- ClinicalTrials.gov ID
- NCT05759169
- Acronym / sponsor ID
- 2021/4587
- Conditions
- Comfort, Fatigue, Symptoms and Signs
- Keywords
- comfort, fatigue,, foot bath, hemodialysis, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 8 Mar 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 study aimed to evaluate the effect of warm water foot baths on comfort, fatigue, and dialysis symptoms in patients undergoing hemodialysis.
This study was conducted as a randomized controlled trial. Data were collected with a total of 58 patients,31 in the intervention group and 27 in the placebo group. The data in the study is collected using the intervention and control group informed volunteer Form, Patient Demonstration Form, foot Bath Application Monitoring Chart, fatigue VAS Scale Form, dialysis Symptom Index, and Hemodialysis Comfort Scale.
Detailed description
After obtaining the necessary permissions for the work to be performed, the researcher explained the purpose of working, and the researcher took the purpose of the work. The voluntary consent of the individuals was provided in verbal and written writing.
The researcher discussed the health team in dialysis centers to ensure that the study was carried out systematically and regularly, providing information on the purpose of the study. The forms to be applied to patients are filled by the researcher using the method of a face-to-face interview and the records obtained from the patient files.
Procedures administered to control groups:
Patients in the control group have been informed about the voluntary Form, Patient Demonstration Form, fatigue VAS Scale Form, dialysis Symptom Index, and Hemodialysis Comfort Scale performed by the researcher in person. At this stage, no attempt was made to the control group at the end of the fourth week; during the last hemodialysis session, the researcher, with the fatigue VAS Scale Form, the dialysis Symptom Index and the Hemodialysis Comfort Scale face-to-face, treated the patients.
Procedures administered to intervention groups:
In line with the literature and expert opinions, each dialysis application has been applied to individuals for 30 minutes for the first 30 minutes of 4 weeks, with a 40-43°C hot water-filled foot wash tub, placing both feet of the individual (Afrasiabifar et al., 2022; Kim et al., 2021 Shafeik et al., 2018). The researcher implemented the voluntary consent Form, Patient Demonstration Form, foot Bath Application Monitoring Chart, fatigue VAS Scale Form, dialysis Symptom Index and Hemodialysis Comfort Scale in person. At the end of the fourth week, the researcher refilled the foot Bath Application Monitoring Chart, the fatigue VAS Scale Form, the dialysis Symptom Index, and the Hemodialysis Comfort Scale. A total of 12 sessions have been performed in the foot bath, including during each dialysis treatment for 4 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was done in a randomized controlled experimental research pattern to determine the effect of the foot bath applied in the last 30 minutes of dialysis treatment on comfort, fatigue and dialysis symptoms for hemodialysis patients.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Foot Bath TubIn line with the literature and expert opinions, each dialysis application has been applied to individuals for 30 minutes for the first 30 minutes of 4 weeks, with a 40-43°C hot water-filled foot wash tub, placing both feet of the individual (Afrasiabifar et al., 2022; Kim et al., 2021 Shafeik et al., 2018). The researcher implemented the voluntary consent Form, Patient Demonstration Form, foot Bath Application Monitoring Chart, fatigue VAS Scale Form, dialysis Symptom Index and Hemodialysis Comfort Scale in person. At the end of the fourth week, the researcher refilled the foot Bath Application Monitoring Chart, the fatigue VAS Scale Form, the dialysis Symptom Index, and the Hemodialysis Comfort Scale. A total of 12 sessions have been performed in the foot bath, including during each dialysis treatment for 4 weeks. |
| Control | No intervention | –Patients in the control group have been informed about the voluntary Form, Patient Demonstration Form, fatigue VAS Scale Form, dialysis Symptom Index, and Hemodialysis Comfort Scale performed by the researcher in person. At this stage, no attempt was made to the control group at the end of the fourth week; during the last hemodialysis session, the researcher, with the fatigue VAS Scale Form, the dialysis Symptom Index and the Hemodialysis Comfort Scale face-to-face, treated the patients. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Over 18 years old,
- For patients over 65 years of age, the standardized Mini-mental Test (SMMT) value is 24 points or higher,
- Without pregnancy,
- With at least 6 months in HD units and 3 sessions per week,
- Continuing dialysis treatment in the same institution,
Key exclusion criteria (8 listed)
- Any psychiatric illness,
- Patients with neurovascular complications, advanced diabetes Mellitus,
- Patients with disease and treatment that trigger fatigue (advanced COPD, cancer, chemotherapy, and radiotherapy patients),
- With open wounds, neuropathy, etc., lower leg problems, which will prevent hot water treatment,
- Patients with peripheral vascular diseases in feet and legs,
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 |
|---|---|---|
| Foot Bath TubA foot bath is generally a form of rest and care where feet are put in water. Feet are body areas where fatigue is most felt as organs that carry the body's total weight. This study uses a specially designed foot bath bath bath bath to give the patients in the experimental group foot bath. The cuvette has four-stage water heating (35-45°C). It has a magnetic field and operates at 390 Watts. It has a splash guard. The sole features non-slip rubber feet. It has a heat shield feature because it has a double wall construction for heat isolation. | Other | Intervention |
Primary outcome
Fatigue VAS Scale Form
Time frame: One mounth. Fatigue levels are at the end of the process and 4 before the application begins. During the last hemodialysis session of the week, fatigue was evaluated by the VAS Scale Form.
The rating of fatigue levels has been expressed to patients that there is no fatigue for 0 points. In comparison, 10 points indicate fatigue is very severe and are questioned how many points they have given to patients for fatigue levels.
Dialysis Symptom Index
Time frame: One mounth. In the first week of the trial and 4 weeks later
DSI contains 30 symptoms that define a specific physical or emotional symptom. Symptoms in the last seven days have been answered as yes-no, and no indicates no symptoms, and yes, that symptom has occurred. If the patient's response is yes, how much the symptom affects is evaluated by a five-type Likert scale. 1 = none, 5 = too many ratings are made. Total scale points are collected. This value varies between 0 and 150. The total scores received show an increase in the effect of the symptom mentioned as approaching 150.
Hemodialysis Comfort Scale
Time frame: One mounth. In the first week of the trial and 4 weeks later
Falcon Orak and Ark. Hemodialysis Comfort Scale (HCS), developed in 2017, with validity reliability, is a reliable scale used to assess the comfort of patients who have had hemodialysis treatment for at least six months. The hemodialysis Comfort Scale is a five-type liquid scale and consists of 9 substances and 2 sub-dimensions. T HCS can score at least 9.00 points and up to 45.00 points; 3.00 points can be achieved at least 15.00 points maximum, relax Alt-size; at least 7.00 points and up to 30.00 points can be obtained from the bottom dimension that is defeated. The increase in the value obtained indicates the level of comfort.
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 8 Mar 2023.
- Individual participant dataSharing planned: No. There is no plan
Related trials for Comfort
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Not yet recruitingObservational study
This Multicentre Study Compares aCUP-E With Standard Electrodes During aEEG Monitoring in NICU Newborns at Risk of Encephalopathy, Assessing Recording Quality, Reliability, Ease of Use and Safety.
Encephalopathy
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruiting
Effects of Environmental Comfort and Oral Motor Stimulation on Comfort and Oral Feeding Readiness in Preterm Infants
Prematurity, Feeding Behaviors
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot Bath Tub in people with Comfort and Fatigue, run by TC Erciyes 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 7 inclusion and 8 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 8 Mar 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?
Fatigue VAS Scale Form (time frame: One mounth. Fatigue levels are at the end of the process and 4 before the application begins. During the last hemodialysis session of the week, fatigue was evaluated by the VAS Scale Form.). The study lists 3 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 8 Mar 2023.