FootNCT05658783
Effect of Footbath on Pain Severity and Sleep Quality
A study testing Hot water foot bath in people with Foot and Sleep, run by Trakya University at 2 sites in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to examine the effect of hot water foot bath on the patients' pain severity and sleep quality levels on the night of the lumbar degenerative disc surgery. The main hypotheses are: H1=Pain severity of the patients who applied footbath is lower than the patients who did not. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Hot water foot bath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 5 Oct 2021to 11 Nov 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
- 18 years old and over
- Undergoing elective surgery
- Surgery planned for lumbar degenerative disc disease
- No known sleep problems and no sleeping pills
- Patients admitted to the ward at least 1 day before the operation
- Those who will spend the night of the day after the operation in the service
- Verbal communicative
- Those who want to take a foot bath in 42oC water
Who cannot join
- Younger than 18 years old
- Unplanned surgery
- Have a diagnosed sleep problem and using sleeping pills
- Having communication problems
- Not volunteering to participate
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Seher Ünver
Edirne, 22030
Başakşehir Çam and Sakura City Hospital
Istanbul
About this study
Official title: The Effect of Footbath on Pain Severity and Sleep Quality Levels of Patients With Lumbar Degenerative Disc Disease
The goal of this clinical trial is to examine the effect of hot water foot bath on the patients' pain severity and sleep quality levels on the night of the lumbar degenerative disc surgery. The main hypotheses are:
- H1=Pain severity of the patients who applied footbath is lower than the patients who did not.
- H2=The sleep quality of the patients who applied footbath is higher than the patients who did not.
Participants will be asked to keep their feet in 42oC hot water for 20 minutes on the night of the day of surgery.
If there is a comparison group: Researchers will compare control group to see if there is any difference on the pain severity and sleep quality of the patients.
Read the detailed description
Group allocation of the patients was done through using Random Allocation Software program and patients were allocated into two groups: the intervention group and the control group.
Patients in the intervention group were asked to take a footbath in 42oC water for 20-minutes in the evening of the surgery day.
The nurse researcher visited the patients in the morning of the surgery day in their service room, asked to rate their current pain severity score between 0 - 10 points, and asked to rate the sleep quality scale items between 0 - 100 points according to their previous night sleep. The patients in the intervention group were informed that they were going to be visited to perform the footbath in the evening before they go asleep, and the patients in the control group were informed that they were going to be visited in the next morning.
In the evening of the surgery day, the nurse researcher visited the patients in their service room and explained footbath procedure to the patients, following, filled the foot tub with hot water to approximately 20 cm above the patients' ankle and measured the temperature of the water with using a water thermometer. When the temperature was stable at 42oC, the patients were asked to sit in semi-fowler position in the bed and to immerse their feet in the foot tub without washing or any massage for 20-minutes. During the footbath, the upper side of the foot tub was covered with a towel to prevent temperature loss by vaporizing and the researcher stayed in the room to observe the patient according to any unwanted events such as sweating, having pain, feeling hot or bad etc. At the end of the footbath procedure, feet of the patients were dried with a towel and checked for any redness. Then, the researcher helped patients to wear their socks to keep the feet warm and measured the final temperature of the water. Finally, the patients were informed that they were going to be visited in the morning.
The standard procedure is pharmacological pain management following the surgery as explained under the study setting title to decrease the pain severity, consequently, to improve the sleep quality, and this standard procedure was used for each group. Footbath was not applied to the patients in the control group.
Patients in both study groups were visited by the nurse researcher in the morning of the postoperative day in their service room, asked to rate their current pain severity score between 0 - 10 points, and asked to rate the sleep quality scale items between 0 - 100 points according to their previous night sleep.
- Being tested
- Hot water foot bath
- Keywords
- Footbath, Perioperative nursing, Post-operative pain, Sleep quality
- Medical subject headings
- Pain, Pain, Postoperative, 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 water foot bathOther
Keeping keep in 42oC (42 Degrees Celsius) hot water for 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in this study group will be asked to keep their feet in 42oC (42 Degrees Celsius) hot water for 20 minutes on the night of the day of surgery. Receives: Other: Hot water foot bath |
| Control Group | No intervention | Participants in this study group will take the standard service clinical procedure and hot water foot bath will not be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity
will be evaluated with using the Visual Analog Scale (VAS), between "0-no pain" score and "10-unbearable pain" score, is used to evaluate perceived back and/or leg pain severity.
Measured: In the morning of the surgery day and in the morning of the post-operative day
Sleep quality
will be evaluated with using the Visual Analog Sleep Scale (VAS-Scale), numbers ranging from 0 (left side) to 100 (right side), is used to evaluate the previous night's sleep quality of patients. This scale was developed by Verran and Snyder-Halpern and the Turkish validity and reliability of the scale was completed by Çetinkaya and Karabulut. It has one dimension and 10 items.
Measured: In the morning of the surgery day and in the morning of the post-operative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start5 Oct 2021
- Primary completion10 Oct 2022
- Study completion11 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FootStudies 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
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seher Ünver, Trakya University
- Investigators
- Seher Ünver, Principal investigator, Trakya UniversityÜlkü Çolakoğlu, Principal investigator, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658783
- Sponsor's protocol ID
- 2020-PO119
- Status last verified
- Mar 2023
- First submitted
- 17 Nov 2022
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Footbath on Pain Severity and Sleep Quality Levels of Patients With Lumbar Degenerative Disc Disease
- ClinicalTrials.gov ID
- NCT05658783
- Acronym / sponsor ID
- 2020-PO119
- Keywords
- Footbath, Perioperative nursing, Post-operative pain, Sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 21 Dec 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.
The goal of this clinical trial is to examine the effect of hot water foot bath on the patients' pain severity and sleep quality levels on the night of the lumbar degenerative disc surgery. The main hypotheses are:
- H1=Pain severity of the patients who applied footbath is lower than the patients who did not.
- H2=The sleep quality of the patients who applied footbath is higher than the patients who did not.
Participants will be asked to keep their feet in 42oC hot water for 20 minutes on the night of the day of surgery.
If there is a comparison group: Researchers will compare control group to see if there is any difference on the pain severity and sleep quality of the patients.
Detailed description
Group allocation of the patients was done through using Random Allocation Software program and patients were allocated into two groups: the intervention group and the control group.
Patients in the intervention group were asked to take a footbath in 42oC water for 20-minutes in the evening of the surgery day.
The nurse researcher visited the patients in the morning of the surgery day in their service room, asked to rate their current pain severity score between 0 - 10 points, and asked to rate the sleep quality scale items between 0 - 100 points according to their previous night sleep. The patients in the intervention group were informed that they were going to be visited to perform the footbath in the evening before they go asleep, and the patients in the control group were informed that they were going to be visited in the next morning.
In the evening of the surgery day, the nurse researcher visited the patients in their service room and explained footbath procedure to the patients, following, filled the foot tub with hot water to approximately 20 cm above the patients' ankle and measured the temperature of the water with using a water thermometer. When the temperature was stable at 42oC, the patients were asked to sit in semi-fowler position in the bed and to immerse their feet in the foot tub without washing or any massage for 20-minutes. During the footbath, the upper side of the foot tub was covered with a towel to prevent temperature loss by vaporizing and the researcher stayed in the room to observe the patient according to any unwanted events such as sweating, having pain, feeling hot or bad etc. At the end of the footbath procedure, feet of the patients were dried with a towel and checked for any redness. Then, the researcher helped patients to wear their socks to keep the feet warm and measured the final temperature of the water. Finally, the patients were informed that they were going to be visited in the morning.
The standard procedure is pharmacological pain management following the surgery as explained under the study setting title to decrease the pain severity, consequently, to improve the sleep quality, and this standard procedure was used for each group. Footbath was not applied to the patients in the control group.
Patients in both study groups were visited by the nurse researcher in the morning of the postoperative day in their service room, asked to rate their current pain severity score between 0 - 10 points, and asked to rate the sleep quality scale items between 0 - 100 points according to their previous night sleep.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Hot water foot bathParticipants in this study group will be asked to keep their feet in 42oC (42 Degrees Celsius) hot water for 20 minutes on the night of the day of surgery. |
| Control Group | No intervention | –Participants in this study group will take the standard service clinical procedure and hot water foot bath will not be applied. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years old and over
- Undergoing elective surgery
- Surgery planned for lumbar degenerative disc disease
- No known sleep problems and no sleeping pills
- Patients admitted to the ward at least 1 day before the operation
Key exclusion criteria (5 listed)
- Younger than 18 years old
- Unplanned surgery
- Have a diagnosed sleep problem and using sleeping pills
- Having communication problems
- Not volunteering to participate
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 water foot bathKeeping keep in 42oC (42 Degrees Celsius) hot water for 20 minutes | Other | Intervention Group |
Primary outcome
Pain severity
Time frame: In the morning of the surgery day and in the morning of the post-operative day
will be evaluated with using the Visual Analog Scale (VAS), between "0-no pain" score and "10-unbearable pain" score, is used to evaluate perceived back and/or leg pain severity.
Sleep quality
Time frame: In the morning of the surgery day and in the morning of the post-operative day
will be evaluated with using the Visual Analog Sleep Scale (VAS-Scale), numbers ranging from 0 (left side) to 100 (right side), is used to evaluate the previous night's sleep quality of patients. This scale was developed by Verran and Snyder-Halpern and the Turkish validity and reliability of the scale was completed by Çetinkaya and Karabulut. It has one dimension and 10 items.
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 9 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
Seher Ünver principal investigator
Trakya University
Ülkü Çolakoğlu principal investigator
Başakşehir Çam & Sakura City Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hot water foot bath in people with Foot and Sleep, run by Trakya University at 2 sites 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 8 inclusion and 5 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 9 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 2 sites 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 severity (time frame: In the morning of the surgery day and in the morning of the post-operative day). 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 9 Mar 2023.