The Effect of FootbathNCT05546684
The Effect of Foot Bath on Postoperative Sleep Quality in Patients Undergoing Transurethral Resection
A study testing footbath in people with The Effect of Footbath, run by Kırklareli University at 1 site in Turkey (Türkiye).
Trial summary
Of the patients who meet the inclusion criteria, 82 will be determined prospectively. Randomization will be determined by means of a computer program called Research randomiser, provided that the number of patients in the experimental and control groups is equal (41:41), regardless of the characteristics of the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- The Effect of Footbath
- What is being tested?
- footbath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Sep 2022to 25 Dec 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
- Those who voluntarily agreed to participate in the study, accepted random selection, were adults, did not have visual/verbal/auditory communication difficulties and mental disabilities that prevented them from answering the questions in the scale, were applied TURP or TURM.
Who cannot join
- Not willing to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kırklareli University
Kırklareli, 39100
About this study
Official title: The Effect of Foot Bath on Postoperative Sleep Quality in Patients Undergoing Transurethral Resection: A Randomized Controlled Study
Of the patients who meet the inclusion criteria, 82 will be determined prospectively. Randomization will be determined by means of a computer program called Research randomiser, provided that the number of patients in the experimental and control groups is equal (41:41), regardless of the characteristics of the patients such as age and gender. The group to which foot bath will be applied will be the experimental group. Other patients will be included in the control group.
Patients who do not meet the study criteria and do not agree to participate in the random selection will not be included in the study.
Read more
Experimental group: Individuals who applied to the urology service for TURP or TURM will be informed about the study 1 day before the operation, and the questions in the patient introduction form will be asked to the patients who declared that they agreed to participate in the study in writing and verbally. RCSQ to determine preoperative sleep quality for patients on the morning of surgery and Patient Methods to be applied / Research protocol to identify confounding factors that may affect sleep (Fill in the appropriate section below).
Eligibility assessment: Of the patients who meet the inclusion criteria, 82 will be determined prospectively.
Providing randomization and separation for intervention: Randomization will be determined by means of a computer program called Research randomiser, provided that the number of patients in the experimental and control groups is equal (41:41), regardless of the characteristics of the patients, such as age and gender. The group to which foot bath will be applied will be the experimental group. Other patients will be included in the control group.
Patients who do not meet the study criteria and do not agree to participate in the random selection will not be included in the study.
Experimental group: Individuals who applied to the urology service for TURP or TURM will be informed about the study 1 day before the operation, and the questions in the patient introduction form will be asked to the patients who declared that they agreed to participate in the study in writing and verbally. On the morning of the surgery, the RCSQ will be applied to the patients to determine the preoperative sleep quality and the Patient follow-up form will be applied to determine the confounding factors that may affect sleep, and after the patient comes from the surgery and the sedation effects have passed, at 21:00 (to prevent the patient from doing any activity after the application and to rest after the foot bath). It was determined as 21:00-22:00 hours for the purpose.) socks, etc., if any, on both feet of the patient. clothes will be removed. In case of using antiembolic stockings, the patient's stockings will be rolled up to the ankle for footbath application (with the approval of the physician). The foot will be examined visually and with the hands and it will be determined that it does not show any signs of disease (pressure injury, discoloration, wound, etc.). The patient will be informed that the footbath device is disinfected before each use and that water-proof bags will be placed on the device to prevent the foot and water from coming into contact with the device in order to allow repeated use. The temperature of the water will be adjusted to 400C with an infrared temperature meter (Non-contact digital thermometer) and both feet will be placed inside the footbath device. The patient's feet will be kept in the footbath device for ten minutes. After the foot bath, the patient's feet will be completely dried with a towel and the existing socks and anti-embolic socks will be put on again (Meltem Nurse). On the morning of the first postoperative day, the patient will be asked the questions in the RCSQ and follow-up form, and the data collection process of the study will be terminated.
Control group: After informing the individuals who applied to the urology service for TURP or TURM about the study, the researcher will receive their informed consent in written form. The information required for the study of the patients in the control group 1 day before the operation will be recorded in the Patient Information Form by the service nurse (Meltem Nurse / Gizem Nurse). On the morning of the surgery, the RCSQ will be applied to the patients to determine the preoperative sleep quality and the Patient follow-up form will be applied to determine the confounding factors that may affect sleep. In the morning of the first day after the surgery, the RCSQ will be applied to the patients to determine the sleep quality on the postoperative day 0 and the Patient follow-up form will be applied to determine other possible factors that may affect sleep, and the data collection process of the study will be terminated. No foot bath application will be in question for the patients in the control group.
- Conditions
- The Effect of Footbath
- Being tested
- footbath
- Keywords
- foot bath, sleep quality,
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
footbathOther
footbath for patients before sleeping
| Study group | Role | What they receive |
|---|---|---|
| foot bath | Experimental | Individuals who apply to the urology service for TURP or TURM will be informed about the study 1 day before the surgery, and the questions in the patient introduction form will be asked to the patients who declared that they agreed to participate in the study in written and verbal form. On the morning of the surgery, the RCSQ will be applied to the patients to determine the preoperative sleep quality, and the Patient follow-up form will be applied to determine the confounding factors that may affect the sleep. The patient's feet will be kept in the footbath device for ten minutes. After the foot bath, the patient's feet will be completely dried with a towel and the existing socks and anti-embolic socks will be put on again. On the morning of the 1st postoperative day, the patient will be asked the questions in the RCSQ and the follow-up form, and the data collection process of the study will be terminated. Receives: Other: footbath |
| Control Group | No intervention | After informing the individuals who applied to the urology service for TURP or TURM about the study, the researcher will receive their informed consent in written form. The information required for the study of the patients in the control group 1 day before the operation will be recorded in the Patient Information Form by the service nurse. On the morning of the surgery, the RCSQ will be applied to the patients to determine the preoperative sleep quality and the Patient follow-up form will be applied to determine the confounding factors that may affect sleep. In the morning of the first day after the surgery, the RCSQ will be applied to the patients to determine the sleep quality on the postoperative day 0, and the Patient follow-up form will be applied to determine other possible factors that may affect sleep, and the data collection process of the study will be terminated. No foot bath application will be in question for the patients in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep quality
The Richards-Campbell Sleep Questionnaire will be used.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start26 Sep 2022
- Primary completion26 Dec 2022
- Study completion25 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Effect of FootbathStudies 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
- Participant
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Figen Dıgın, Kırklareli University
- Investigators
- Figen Dığın, Dr, Study chair, Kırklareli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546684
- Sponsor's protocol ID
- TUTF-GOBAEK 2022/152
- Status last verified
- Oct 2023
- First submitted
- 13 Sep 2022
- Last updated
- 4 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Foot Bath on Postoperative Sleep Quality in Patients Undergoing Transurethral Resection: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05546684
- Acronym / sponsor ID
- TUTF-GOBAEK 2022/152
- Conditions
- The Effect of Footbath
- Keywords
- foot bath, sleep quality,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 26 Dec 2022 (actual)
- Study completion
- 25 Dec 2023 (estimated)
- First posted
- 21 Sep 2022 (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.
Of the patients who meet the inclusion criteria, 82 will be determined prospectively. Randomization will be determined by means of a computer program called Research randomiser, provided that the number of patients in the experimental and control groups is equal (41:41), regardless of the characteristics of the patients such as age and gender. The group to which foot bath will be applied will be the experimental group. Other patients will be included in the control group.
Patients who do not meet the study criteria and do not agree to participate in the random selection will not be included in the study.
Experimental group: Individuals who applied to the urology service for TURP or TURM will be informed about the study 1 day before the operation, and the questions in the patient introduction form will be asked to the patients who declared that they agreed to participate in the study in writing and verbally. RCSQ to determine preoperative sleep quality for patients on the morning of surgery and Patient Methods to be applied / Research protocol to identify confounding factors that may affect sleep (Fill in the appropriate section below).
Eligibility assessment: Of the patients who meet the inclusion criteria, 82 will be determined prospectively.
Providing randomization and separation for intervention: Randomization will be determined by means of a computer program called Research randomiser, provided that the number of patients in the experimental and control groups is equal (41:41), regardless of the characteristics of the patients, such as age and gender. The group to which foot bath will be applied will be the experimental group. Other patients will be included in the control group.
Patients who do not meet the study criteria and do not agree to participate in the random selection will not be included in the study.
Experimental group: Individuals who applied to the urology service for TURP or TURM will be informed about the study 1 day before the operation, and the questions in the patient introduction form will be asked to the patients who declared that they agreed to participate in the study in writing and verbally. On the morning of the surgery, the RCSQ will be applied to the patients to determine the preoperative sleep quality and the Patient follow-up form will be applied to determine the confounding factors that may affect sleep, and after the patient comes from the surgery and the sedation effects have passed, at 21:00 (to prevent the patient from doing any activity after the application and to rest after the foot bath). It was determined as 21:00-22:00 hours for the purpose.) socks, etc., if any, on both feet of the patient. clothes will be removed. In case of using antiembolic stockings, the patient's stockings will be rolled up to the ankle for footbath application (with the approval of the physician). The foot will be examined visually and with the hands and it will be determined that it does not show any signs of disease (pressure injury, discoloration, wound, etc.). The patient will be informed that the footbath device is disinfected before each use and that water-proof bags will be placed on the device to prevent the foot and water from coming into contact with the device in order to allow repeated use. The temperature of the water will be adjusted to 400C with an infrared temperature meter (Non-contact digital thermometer) and both feet will be placed inside the footbath device. The patient's feet will be kept in the footbath device for ten minutes. After the foot bath, the patient's feet will be completely dried with a towel and the existing socks and anti-embolic socks will be put on again (Meltem Nurse). On the morning of the first postoperative day, the patient will be asked the questions in the RCSQ and follow-up form, and the data collection process of the study will be terminated.
Control group: After informing the individuals who applied to the urology service for TURP or TURM about the study, the researcher will receive their informed consent in written form. The information required for the study of the patients in the control group 1 day before the operation will be recorded in the Patient Information Form by the service nurse (Meltem Nurse / Gizem Nurse). On the morning of the surgery, the RCSQ will be applied to the patients to determine the preoperative sleep quality and the Patient follow-up form will be applied to determine the confounding factors that may affect sleep. In the morning of the first day after the surgery, the RCSQ will be applied to the patients to determine the sleep quality on the postoperative day 0 and the Patient follow-up form will be applied to determine other possible factors that may affect sleep, and the data collection process of the study will be terminated. No foot bath application will be in question for the patients in the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| foot bath | Experimental | Other: footbathIndividuals who apply to the urology service for TURP or TURM will be informed about the study 1 day before the surgery, and the questions in the patient introduction form will be asked to the patients who declared that they agreed to participate in the study in written and verbal form. On the morning of the surgery, the RCSQ will be applied to the patients to determine the preoperative sleep quality, and the Patient follow-up form will be applied to determine the confounding factors that may affect the sleep. The patient's feet will be kept in the footbath device for ten minutes. After the foot bath, the patient's feet will be completely dried with a towel and the existing socks and anti-embolic socks will be put on again. On the morning of the 1st postoperative day, the patient will be asked the questions in the RCSQ and the follow-up form, and the data collection process of the study will be terminated. |
| Control Group | No intervention | –After informing the individuals who applied to the urology service for TURP or TURM about the study, the researcher will receive their informed consent in written form. The information required for the study of the patients in the control group 1 day before the operation will be recorded in the Patient Information Form by the service nurse. On the morning of the surgery, the RCSQ will be applied to the patients to determine the preoperative sleep quality and the Patient follow-up form will be applied to determine the confounding factors that may affect sleep. In the morning of the first day after the surgery, the RCSQ will be applied to the patients to determine the sleep quality on the postoperative day 0, and the Patient follow-up form will be applied to determine other possible factors that may affect sleep, and the data collection process of the study will be terminated. No foot bath application will be in question for the patients in the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Those who voluntarily agreed to participate in the study, accepted random selection, were adults, did not have visual/verbal/auditory communication difficulties and mental disabilities that prevented them from answering the questions in the scale, were applied TURP or TURM.
Key exclusion criteria (1 listed)
- Not willing to participate in the study
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 |
|---|---|---|
| footbathfootbath for patients before sleeping | Other | foot bath |
Primary outcome
sleep quality
Time frame: 1 year
The Richards-Campbell Sleep Questionnaire will be used.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
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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.
Figen Dığın, Dr study chair
Kırklareli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing footbath in people with The Effect of Footbath, run by Kırklareli 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeynep Kızılcık Özkan, Dr (+905056010101, zeynepkizilcik26@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep quality (time frame: 1 year). 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 4 Oct 2023.