Nursing CariesNCT05705908
Effect of Foot Bath on Postoperative Sleep Quality and Pain
A study testing Hot Foot Bath 1 and Hot Foot Bath 2 in people with Nursing Caries and Pain, Postoperative, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
One of the most common problems in patients in the postoperative period is pain and the associated deterioration in sleep quality. Deterioration in sleep quality can cause pain to be perceived more severely. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Nursing Caries, Pain, Postoperative, Sleep Deprivation
- What is being tested?
- Hot Foot Bath 1 and Hot Foot Bath 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2021to 19 Jul 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and over
- Electively planned robotic and laparoscopic abdominal (colorectal, hepatobiliary, gastric and esophageal surgery, bariatric surgery, peritoneal membrane cancer) surgical operations
- Surgeries performed under general anesthesia
- Patients who have been hospitalized for at least 3 days after surgery
- Patients without a detected sleep disorder (Patients with Insomnia Severity Index score between 0-7) will be included in the study.
Who cannot join
- Patients who constantly take a foot bath
- Emergency surgeries
- Those with literacy disabilities
- Those with physical and mental disabilities
- Patients with diabetes for more than 10 years
- Patients with diabetic foot, neuropathy, foot pressure sores or any skin disease on their feet
Show all 12Show fewer
- Those with vascular diseases
- Those who are allergic to lavender
- Those with neurological diseases (dementia, alzheimer, etc.)
- Those who regularly use sleep and psychoactive drugs
- Those who use drugs that affect sleep during hospitalization (sedatives, etc.)
- Patients who were transferred to the post-operative revision or general intensive care unit will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Foot Bath Using Warm Water and Lavender Essential Oil on Postoperative Sleep Quality and Pain: A Randomized Controlled Study
One of the most common problems in patients in the postoperative period is pain and the associated deterioration in sleep quality. Deterioration in sleep quality can cause pain to be perceived more severely. It is recommended to use non-pharmacological approaches as well as pharmacological interventions in the management of these problems. This study was planned to determine the effect of hot foot bath and lavender essential oil foot bath application on postoperative sleep quality and pain in patients undergoing abdominal surgery.
Read the detailed description
It was planned as a randomized controlled trial. The population of the study consisted of patients who underwent abdominal surgery in the General Surgery Service of a private health group hospital in Istanbul. Patients who met the inclusion criteria constituted the sample.
"Visual Comparison Scale-VAS" and "Richard-Campbell Sleep Scale" were used during data collection.
Visual Comparison Scale-VAS: It is a scale that starts with no pain and ends with unbearable. The VAS scale consists of a 10 cm long line. At one end of the line, "no pain" signals what may be at the other end of the "unbearable pain." The patient is asked to point to a point that indicates the current level of pain.
Richard-Campbell Sleep Scale: This scale consists of 6 items that evaluate the depth of night sleep, the time to fall asleep, the frequency of awakening, the time to stay awake when awakened, the quality of sleep and the noise level of the environment. Each item is evaluated on a chart between 0 and 100 using the visual analog scale technique. According to the scale, the score in the range of "0-25" indicates very bad sleep, and the score in the range of "76-100" indicates very good sleep.
Foot bath was started as of the 24th hour after the operation. During the 3 days they were hospitalized, they had a foot bath evening before going to sleep (experimental group). Routine service applications were performed in the control group. In order to ensure the comfort of the experimental and control group patients and to minimize their exposure to the external environment, the patient rooms were kept clean, at a suitable temperature (23-25 degrees) and quiet.
- Conditions
- Nursing Caries, Pain, Postoperative, Sleep Deprivation
- Being tested
- Hot Foot Bath 1, Hot Foot Bath 2
- Keywords
- Sleep quality, pain management, post-operative care, foot bath
- Medical subject headings
- Pain, Postoperative, Sleep Deprivation, Sleep Initiation and Maintenance Disorders, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot Foot Bath 1Other
- Hot foot bath device has a built-in heater (max. 44°C),
- Hot foot bath device has anti-slip base, vibration and 2 rotating massage rollers, digital display/control panel and timer (20-60 minutes).
- It is filled with water at 40 degrees so that it passes the ankle of the patient by 20 cm (4 liters of water).
Hot Foot Bath 2Other
- Hot foot bath device has a built-in heater (max. 44°C),
- Hot foot bath device has anti-slip base, vibration and 2 rotating massage rollers, digital display/control panel and timer (20-60 minutes).
- It is filled with water at 40 degrees so that it passes the ankle of the patient by 20 cm (4 liters of water).
- 3 drops of lavender essential oil were dripped in the water
| Study group | Role | What they receive |
|---|---|---|
| Control Group - No foot bath | No intervention | * 24 hours after surgery - did not give foot bath to patients * Pain was evaluated with VAS scale. Post-operative 24th hour, 28th hour, 32nd hour, 36th hour, 40th hour, 44th hour, 48th hour, 52nd hour, 56th hour, 58th hour, 62nd Hour, 64th Hour., 68th Hour, 72nd Hour * Sleep Questionnaire was administered at 08:00-09:00 in the morning when the patient woke up; 24th hour, 48 th hour, 72 th hour. |
| Experimental Group- Hot Foot Bath 1 | Experimental | * Post operative 24th hour - 48 th hour - 72 nd hour - gave patients hot foot bath
* Patient was seated in an upright position.
* FM 4020 Grundig brand footbath device was used for the Hot Foot Bath.
* It was filled with 40 degrees water, 20 cm (4 lt. of water)
* Soaked in hot water up to the ankles
* The foot bath was continued for 20 minutes with the feet in the device.
* After 20 minutes, the patient's feet were dried with a towel.
* After the foot bath pain was evaluated with VAS scale. Post-operative 24th hour, 28th hour, 32nd hour, 36th hour, 40th hour, 44th hour, 48th hour, 52nd hour, 56th hour, 58th hour, 62nd Hour, 64th Hour., 68th Hour, 72nd Hour
* Sleep Questionnaire was administered at 08:00-09:00 in the morning when the patient woke up; 24th hour, 48 th hour, 72 th hour. Receives: Other: Hot Foot Bath 1 |
| Experimental Group- Hot Foot Bath 2 | Experimental | * Post operative 24th hour - 48 th hour - 72 nd hour - gave patients hot foot bath with Lavender Essential Oil
* Patient was seated in an upright position.
* FM 4020 Grundig brand footbath device was used for the Hot Foot Bath.
* It was filled with 40 degrees water, 20 cm (4 lt. of water)
* Soaked in hot water up to the ankles
* The foot bath with Lavender Essential Oil was continued for 20 minutes with the feet in the device.
* After 20 minutes, the patient's feet were dried with a towel.
* After the foot bath with Lavender Essential Oil pain was evaluated with VAS scale. Post-operative 24th hour, 28th hour, 32nd hour, 36th hour, 40th hour, 44th hour, 48th hour, 52nd hour, 56th hour, 58th hour, 62nd Hour, 64th Hour., 68th Hour, 72nd Hour
* Sleep Questionnaire was administered at 08:00-09:00 in the morning when the patient woke up; 24th hour, 48 th hour, 72 th hour. Receives: Other: Hot Foot Bath 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change between Post-operative Pain Score
The Pain scale - VAS scale consists of a 10 cm long line. At one end of the line, "no pain" signals what may be at the other end of the "unbearable pain." The patient is asked to point to a point that indicates the current level of pain.
The difference between pain scores over 3 days will be evaluated in hospital Patient's pain was evaluated with VAS - 14 times after surgery. Immediately after surgery means 0th hour.
These times; post-operative 24th hour, 28th hour, 32nd hour, 36th hour, 40th hour, 44th hour, 48th hour, 52nd hour, 56th hour, 58th hour, 62nd Hour, 64th Hour., 68th Hour, 72nd Hour.
It will be measured for the last time at 72 hours and data collection will be finished here
Measured: Post-operative Change between Pain Score; 24th hour, 28th hour, 32nd hour, 36th hour, 40th hour, 44th hour, 48th hour, 52nd hour, 56th hour, 58th hour, 62nd Hour, 64th Hour, 68th Hour, 72nd Hour (data collection will be finished here)
Secondary outcomes (1)
Change between Sleep Scale Score
Richard-Campbell Sleep Scale: This scale consists of 6 items that evaluate the depth of night sleep, the time to fall asleep, the frequency of awakening, the time to stay awake when awakened, the quality of sleep and the noise level of the environment. Each item is evaluated on a chart between 0 and 100 using the visual analog scale technique. According to the scale, the score in the range of "0-25" indicates very bad sleep, and the score in the range of "76-100" indicates very good sleep.
Sleep Scale was administered at 08:00-09:00 in the morning (when the patient woke up) in hospital - 3 times. Immediately after surgery means 0th hour.
These times; post-operative 24th Hour, 48th Hour, 72th Hour. It will be measured for the last time at 72 hours and data collection will be finished here
Measured: Post-operative change between sleep scale score; 24th Hour, 48th Hour, 72th Hour (data collection will be finished here)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start15 May 2021
- Primary completion19 Jul 2023
- Study completion19 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nursing CariesStudies of the same condition, open and under way.
- More trials run by Acibadem 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Acibadem University, Acibadem University
- Investigators
- Yasemin Uslu, Asisst Prof, Study chair, Acıbadem Mehmet Ali Aydınlar Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705908
- Sponsor's protocol ID
- ATADEK 2021-19/19
- Status last verified
- Jul 2023
- First submitted
- 25 May 2022
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Armat MR, Mortazavi H, Akbari H, Ebrahimzadeh Z. The effect of footbath on the quality of sleep in older adults: A pilot study. Geriatr Nurs. 2021 Sep-Oct;42(5):1178-1183. doi: 10.1016/j.gerinurse.2021.07.008. Epub 2021 Aug 20.
PubMed 34419870Talebi Ghadicolaei H, Heydary Gorji MA, Bagheri B, Yazdani Charati J, Hadinejad Z. The Effect of Warm Footbath on the Quality of Sleep on Patients with Acute Coronary Syndrome in Cardiac Care Unit. J Caring Sci. 2019 Sep 1;8(3):137-142. doi: 10.15171/jcs.2019.020. eCollection 2019 Sep.
PubMed 31598506Seyyedrasooli A, Valizadeh L, Zamanzadeh V, Nasiri K, Kalantri H. The effect of footbath on sleep quality of the elderly: a blinded randomized clinical trial. J Caring Sci. 2013 Nov 30;2(4):305-11. doi: 10.5681/jcs.2013.036. eCollection 2013 Dec.
PubMed 25276739Effati-Daryani F, Mohammad-Alizadeh-Charandabi S, Mirghafourvand M, Taghizadeh M, Bekhradi R, Zarei S. Effect of Lavender cream with or without footbath on sleep quality and fatigue in pregnancy and postpartum: a randomized controlled trial. Women Health. 2018 Nov-Dec;58(10):1179-1191. doi: 10.1080/03630242.2017.1414101. Epub 2018 May 22.
PubMed 29787355Kim HJ, Lee Y, Sohng KY. The effects of footbath on sleep among the older adults in nursing home: A quasi-experimental study. Complement Ther Med. 2016 Jun;26:40-6. doi: 10.1016/j.ctim.2016.02.005. Epub 2016 Feb 15.
PubMed 27261980
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Foot Bath Using Warm Water and Lavender Essential Oil on Postoperative Sleep Quality and Pain: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05705908
- Acronym / sponsor ID
- ATADEK 2021-19/19
- Conditions
- Nursing Caries, Pain, Postoperative, Sleep Deprivation
- Keywords
- Sleep quality, pain management, post-operative care, foot bath
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 19 Jul 2023 (actual)
- First posted
- 31 Jan 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.
One of the most common problems in patients in the postoperative period is pain and the associated deterioration in sleep quality. Deterioration in sleep quality can cause pain to be perceived more severely. It is recommended to use non-pharmacological approaches as well as pharmacological interventions in the management of these problems. This study was planned to determine the effect of hot foot bath and lavender essential oil foot bath application on postoperative sleep quality and pain in patients undergoing abdominal surgery.
Detailed description
It was planned as a randomized controlled trial. The population of the study consisted of patients who underwent abdominal surgery in the General Surgery Service of a private health group hospital in Istanbul. Patients who met the inclusion criteria constituted the sample.
"Visual Comparison Scale-VAS" and "Richard-Campbell Sleep Scale" were used during data collection.
Visual Comparison Scale-VAS: It is a scale that starts with no pain and ends with unbearable. The VAS scale consists of a 10 cm long line. At one end of the line, "no pain" signals what may be at the other end of the "unbearable pain." The patient is asked to point to a point that indicates the current level of pain.
Richard-Campbell Sleep Scale: This scale consists of 6 items that evaluate the depth of night sleep, the time to fall asleep, the frequency of awakening, the time to stay awake when awakened, the quality of sleep and the noise level of the environment. Each item is evaluated on a chart between 0 and 100 using the visual analog scale technique. According to the scale, the score in the range of "0-25" indicates very bad sleep, and the score in the range of "76-100" indicates very good sleep.
Foot bath was started as of the 24th hour after the operation. During the 3 days they were hospitalized, they had a foot bath evening before going to sleep (experimental group). Routine service applications were performed in the control group. In order to ensure the comfort of the experimental and control group patients and to minimize their exposure to the external environment, the patient rooms were kept clean, at a suitable temperature (23-25 degrees) and quiet.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control Group - No foot bath | No intervention | –* 24 hours after surgery - did not give foot bath to patients * Pain was evaluated with VAS scale. Post-operative 24th hour, 28th hour, 32nd hour, 36th hour, 40th hour, 44th hour, 48th hour, 52nd hour, 56th hour, 58th hour, 62nd Hour, 64th Hour., 68th Hour, 72nd Hour * Sleep Questionnaire was administered at 08:00-09:00 in the morning when the patient woke up; 24th hour, 48 th hour, 72 th hour. |
| Experimental Group- Hot Foot Bath 1 | Experimental | Other: Hot Foot Bath 1* Post operative 24th hour - 48 th hour - 72 nd hour - gave patients hot foot bath * Patient was seated in an upright position. * FM 4020 Grundig brand footbath device was used for the Hot Foot Bath. * It was filled with 40 degrees water, 20 cm (4 lt. of water) * Soaked in hot water up to the ankles * The foot bath was continued for 20 minutes with the feet in the device. * After 20 minutes, the patient's feet were dried with a towel. * After the foot bath pain was evaluated with VAS scale. Post-operative 24th hour, 28th hour, 32nd hour, 36th hour, 40th hour, 44th hour, 48th hour, 52nd hour, 56th hour, 58th hour, 62nd Hour, 64th Hour., 68th Hour, 72nd Hour * Sleep Questionnaire was administered at 08:00-09:00 in the morning when the patient woke up; 24th hour, 48 th hour, 72 th hour. |
| Experimental Group- Hot Foot Bath 2 | Experimental | Other: Hot Foot Bath 2* Post operative 24th hour - 48 th hour - 72 nd hour - gave patients hot foot bath with Lavender Essential Oil * Patient was seated in an upright position. * FM 4020 Grundig brand footbath device was used for the Hot Foot Bath. * It was filled with 40 degrees water, 20 cm (4 lt. of water) * Soaked in hot water up to the ankles * The foot bath with Lavender Essential Oil was continued for 20 minutes with the feet in the device. * After 20 minutes, the patient's feet were dried with a towel. * After the foot bath with Lavender Essential Oil pain was evaluated with VAS scale. Post-operative 24th hour, 28th hour, 32nd hour, 36th hour, 40th hour, 44th hour, 48th hour, 52nd hour, 56th hour, 58th hour, 62nd Hour, 64th Hour., 68th Hour, 72nd Hour * Sleep Questionnaire was administered at 08:00-09:00 in the morning when the patient woke up; 24th hour, 48 th hour, 72 th hour. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years and over
- Electively planned robotic and laparoscopic abdominal (colorectal, hepatobiliary, gastric and esophageal surgery, bariatric surgery, peritoneal membrane cancer) surgical operations
- Surgeries performed under general anesthesia
- Patients who have been hospitalized for at least 3 days after surgery
- Patients without a detected sleep disorder (Patients with Insomnia Severity Index score between 0-7) will be included in the study.
Key exclusion criteria (12 listed)
- Patients who constantly take a foot bath
- Emergency surgeries
- Those with literacy disabilities
- Those with physical and mental disabilities
- Patients with diabetes for more than 10 years
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 1* Hot foot bath device has a built-in heater (max. 44°C), * Hot foot bath device has anti-slip base, vibration and 2 rotating massage rollers, digital display/control panel and timer (20-60 minutes). * It is filled with water at 40 degrees so that it passes the ankle of the patient by 20 cm (4 liters of water). | Other | Experimental Group- Hot Foot Bath 1 |
| Hot Foot Bath 2* Hot foot bath device has a built-in heater (max. 44°C), * Hot foot bath device has anti-slip base, vibration and 2 rotating massage rollers, digital display/control panel and timer (20-60 minutes). * It is filled with water at 40 degrees so that it passes the ankle of the patient by 20 cm (4 liters of water). * 3 drops of lavender essential oil were dripped in the water | Other | Experimental Group- Hot Foot Bath 2 |
Primary outcome
Change between Post-operative Pain Score
Time frame: Post-operative Change between Pain Score; 24th hour, 28th hour, 32nd hour, 36th hour, 40th hour, 44th hour, 48th hour, 52nd hour, 56th hour, 58th hour, 62nd Hour, 64th Hour, 68th Hour, 72nd Hour (data collection will be finished here)
The Pain scale - VAS scale consists of a 10 cm long line. At one end of the line, "no pain" signals what may be at the other end of the "unbearable pain." The patient is asked to point to a point that indicates the current level of pain. The difference between pain scores over 3 days will be evaluated in hospital Patient's pain was evaluated with VAS - 14 times after surgery. Immediately after surgery means 0th hour. These times; post-operative 24th hour, 28th hour, 32nd hour, 36th hour, 40th hour, 44th hour, 48th hour, 52nd hour, 56th hour, 58th hour, 62nd Hour, 64th Hour., 68th Hour, 72nd Hour. It will be measured for the last time at 72 hours and data collection will be finished here
1 secondary outcome
Change between Sleep Scale Score
Time frame: Post-operative change between sleep scale score; 24th Hour, 48th Hour, 72th Hour (data collection will be finished here)
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 24 Jul 2023.
- Results publication: PubMed 34419870Armat MR, Mortazavi H, Akbari H, Ebrahimzadeh Z. The effect of footbath on the quality of sleep in older adults: A pilot study. Geriatr Nurs. 2021 Sep-Oct;42(5):1178-1183. doi: 10.1016/j.gerinurse.2021.07.008. Epub 2021 Aug 20.
- Results publication: PubMed 31598506Talebi Ghadicolaei H, Heydary Gorji MA, Bagheri B, Yazdani Charati J, Hadinejad Z. The Effect of Warm Footbath on the Quality of Sleep on Patients with Acute Coronary Syndrome in Cardiac Care Unit. J Caring Sci. 2019 Sep 1;8(3):137-142. doi: 10.15171/jcs.2019.020. eCollection 2019 Sep.
- Results publication: PubMed 25276739Seyyedrasooli A, Valizadeh L, Zamanzadeh V, Nasiri K, Kalantri H. The effect of footbath on sleep quality of the elderly: a blinded randomized clinical trial. J Caring Sci. 2013 Nov 30;2(4):305-11. doi: 10.5681/jcs.2013.036. eCollection 2013 Dec.
- Results publication: PubMed 29787355Effati-Daryani F, Mohammad-Alizadeh-Charandabi S, Mirghafourvand M, Taghizadeh M, Bekhradi R, Zarei S. Effect of Lavender cream with or without footbath on sleep quality and fatigue in pregnancy and postpartum: a randomized controlled trial. Women Health. 2018 Nov-Dec;58(10):1179-1191. doi: 10.1080/03630242.2017.1414101. Epub 2018 May 22.
- Results publication: PubMed 27261980Kim HJ, Lee Y, Sohng KY. The effects of footbath on sleep among the older adults in nursing home: A quasi-experimental study. Complement Ther Med. 2016 Jun;26:40-6. doi: 10.1016/j.ctim.2016.02.005. Epub 2016 Feb 15.
- Individual participant dataSharing planned: No
Related trials for Nursing Caries
Not yet recruitingPhase 4
Oral Hygiene Assistance Training Program
Elderly, Periodontal Disease
Not yet recruiting
Virtual Escape Room Game About Medical Device in Nurses
Nursing Caries, Pressure Injuries
Recruiting
Extending Dental Care to Nursing Home Residents to Reduce Mouth Infections and Incidence of Pneumonia and Improve Diabetic Glucose Control
Periodontitis, Gingivitis
Not yet recruiting
Flipped Learning Model on the Stoma Care
Stoma Colostomy, Nursing Caries
Not yet recruiting
Flipped Learning Model on Nursing Students' Thorax and Heart Examination
Nursing Students, Nursing Caries
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.
Yasemin Uslu, Asisst Prof study chair
Acıbadem Mehmet Ali Aydınlar Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hot Foot Bath 1 and Hot Foot Bath 2 in people with Nursing Caries and Pain, Postoperative, run by Acibadem 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 5 inclusion and 12 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 24 Jul 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?
Change between Post-operative Pain Score (time frame: Post-operative Change between Pain Score; 24th hour, 28th hour, 32nd hour, 36th hour, 40th hour, 44th hour, 48th hour, 52nd hour, 56th hour, 58th hour, 62nd Hour, 64th Hour, 68th Hour, 72nd Hour (data collection will be finished here)). 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 NCT05705908, which also lists 5 linked publications.
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 24 Jul 2023.