Laparoscopic CholecystectomyNCT06177873
Effect of Foot Bath on Pain, Anxiety, Sleep and Comfort Level
A study testing foot bath in people with Laparoscopic Cholecystectomy, run by Dilek GÜRÇAYIR at 1 site in Turkey (Türkiye).
Trial summary
This study was planned and will conducted to determine the effect of hot foot bath on pain, anxiety, sleep and comfort levels in patients undergoing laparoscopic cholecystectomy. Research hypotheses H1: A hot foot bath reduces postoperative pain in patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- foot bath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 30 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Patients did not have any psychological disorders, cancer, hypertension or heart disease and did not use any medication related to these diseases
- Patients used the same type of analgesic for pain control in the postoperative period,
- Patients had a VAS pain level of 4 or above, had no foot pain
- Patients who did not have wounds, infections or infectious diseases
- Patients who did not develop any complications before, during and after surgery were
Who cannot join
- Patients who developed any complications before, during or after surgery
- Patients who had drains were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Foot Bath on Pain, Anxiety, Sleep and Comfort Level: Randomized Control
This study was planned and will conducted to determine the effect of hot foot bath on pain, anxiety, sleep and comfort levels in patients undergoing laparoscopic cholecystectomy.
Research hypotheses H1: A hot foot bath reduces postoperative pain in patients undergoing laparoscopic cholecystectomy.
H2: A hot foot bath reduces postoperative anxiety in patients undergoing laparoscopic cholecystectomy.
H3: A hot foot bath improves postoperative sleep in patients undergoing laparoscopic cholecystectomy.
H4: A hot foot bath improves postoperative comfort in patients undergoing laparoscopic cholecystectomy.
Read the detailed description
Nurses play an important role in patients; pain management during the peroperative period. In this process, non-steroidal anti-inflammatory drugs, opioids, patient-controlled analgesia and local anesthetics can be used pharmacologically in pain management. However, it has been reported in the literature that using pharmacological and non-pharmacological applications together in pain management has better positive effects on the patient. Hot application, cold application, transcutaneous electrical nerve stimulation, massage, reiki, music therapy, aromatherapy are some of the non-pharmacological applications used to relieve pain in the postoperative period.
Hot application is one of the effective, cheap and easy-to-use non-pharmacological methods in relieving pain. Hot applications can be made as dry hot, local wet and general wet applications. Foot bath with hot water is one of the non-pharmacological methods that nurses can apply to relieve post-operative patients; pain, reduce anxiety and stress levels, relax muscles and improve sleep quality. There are studies in the literature showing that heat application reduces pain levels and improves sleep quality in different patient groups. In the study of Aghamohammadi et al., it was found that a 20-minute hot foot bath applied to women in menopause improved sleep quality. In the study of Han et al., it was found that hot foot bath with aromatherapy applied to patients with edema in the lower extremities significantly reduced pain and edema. In the study of Soonyoung and Myoungjin, it was determined that hot water foot bath applied to patients who underwent hand replantation reduced the pain of the patients. In another study, hand and foot baths after cesarean section were effective in reducing the pain of patients. When the literature was examined, no study was found examining the effect of hot foot bath on anxiety, pain, sleep and comfort levels after laparoscopic cholecystectomy. In this context, this study was planned and conducted to determine the effect of hot foot bath on pain, anxiety, sleep and comfort levels in patients undergoing laparoscopic cholecystectomy.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- foot bath
- Keywords
- foot bath, pain, anxiety, comfort, sleep
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foot bathOther
On the morning of surgery, the purpose of the study will be explained to the patients and their written consent will be obtained. Then, Introductory Information Form, STAI and VASS were applied. The pain level of the patients will be evaluated with VAS-Pain 4 hours after the surgery. SAI and VAS-Comfort will be applied to patients with pain level 4 and above. Then, patients in the experimental group will receive a hot water foot bath for 20 minutes. Before the hot water foot bath, patients will be lifted from their beds and placed on the chair in the room. Hot water will be poured into the foot bath tub and the patient will be asked to put his feet in the water. The water level will be adjusted to include the patients ankles. The temperature of the water will be constantly checked with a water thermometer and kept at 41-42 °C. A hot water foot bath will be applied for 20 minutes and then the patients feet will be dried with a towel.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Hot water foot bath will applied to intervention group. Receives: Other: foot bath |
| control group | No intervention | Patients in the control group will not have a hot water foot bath and the scales will be applied at the same hours as the patients in the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog pain scale
Zero is equivalent to no pain and 10 indicates the worst possible pain.
Measured: 4 hours after the surgery, after the application at the 5th, 30th, 60th and 120th minutes.
Visual Analog Comfort scale
Zero is equivalent to no comfort and 10 indicates the worst possible comfort.
Measured: 4 hours after the surgery, after the application at the 5th, 30th, 60th and 120th minutes.
Visual Analog Sleep Scale
Zero is equivalent to the best sleep and 1000 indicates the worst possible sleep.
Measured: On the surgery morning, first day after surgery.
The State-Trait Anxiety Inventory Form (STAI)
20 is equivalent to no anxiety and 80 indicates the worst possible anxiety.
Measured: 4 hours after the surgery, after the application at the 5th, 30th, 60th and 120th minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start1 Jan 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies 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
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dilek GÜRÇAYIR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dilek GÜRÇAYIR, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177873
- Sponsor's protocol ID
- 501100004951
- Status last verified
- Dec 2025
- First submitted
- 28 Nov 2023
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Foot Bath on Pain, Anxiety, Sleep and Comfort Level: Randomized Control
- ClinicalTrials.gov ID
- NCT06177873
- Acronym / sponsor ID
- 501100004951
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- foot bath, pain, anxiety, comfort, sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Dilek GÜRÇAYIRUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 20 Dec 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 was planned and will conducted to determine the effect of hot foot bath on pain, anxiety, sleep and comfort levels in patients undergoing laparoscopic cholecystectomy.
Research hypotheses H1: A hot foot bath reduces postoperative pain in patients undergoing laparoscopic cholecystectomy.
H2: A hot foot bath reduces postoperative anxiety in patients undergoing laparoscopic cholecystectomy.
H3: A hot foot bath improves postoperative sleep in patients undergoing laparoscopic cholecystectomy.
H4: A hot foot bath improves postoperative comfort in patients undergoing laparoscopic cholecystectomy.
Detailed description
Nurses play an important role in patients; pain management during the peroperative period. In this process, non-steroidal anti-inflammatory drugs, opioids, patient-controlled analgesia and local anesthetics can be used pharmacologically in pain management. However, it has been reported in the literature that using pharmacological and non-pharmacological applications together in pain management has better positive effects on the patient. Hot application, cold application, transcutaneous electrical nerve stimulation, massage, reiki, music therapy, aromatherapy are some of the non-pharmacological applications used to relieve pain in the postoperative period.
Hot application is one of the effective, cheap and easy-to-use non-pharmacological methods in relieving pain. Hot applications can be made as dry hot, local wet and general wet applications. Foot bath with hot water is one of the non-pharmacological methods that nurses can apply to relieve post-operative patients; pain, reduce anxiety and stress levels, relax muscles and improve sleep quality. There are studies in the literature showing that heat application reduces pain levels and improves sleep quality in different patient groups. In the study of Aghamohammadi et al., it was found that a 20-minute hot foot bath applied to women in menopause improved sleep quality. In the study of Han et al., it was found that hot foot bath with aromatherapy applied to patients with edema in the lower extremities significantly reduced pain and edema. In the study of Soonyoung and Myoungjin, it was determined that hot water foot bath applied to patients who underwent hand replantation reduced the pain of the patients. In another study, hand and foot baths after cesarean section were effective in reducing the pain of patients. When the literature was examined, no study was found examining the effect of hot foot bath on anxiety, pain, sleep and comfort levels after laparoscopic cholecystectomy. In this context, this study was planned and conducted to determine the effect of hot foot bath on pain, anxiety, sleep and comfort levels in patients undergoing laparoscopic cholecystectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: foot bathHot water foot bath will applied to intervention group. |
| control group | No intervention | –Patients in the control group will not have a hot water foot bath and the scales will be applied at the same hours as the patients in the experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- Patients did not have any psychological disorders, cancer, hypertension or heart disease and did not use any medication related to these diseases
- Patients used the same type of analgesic for pain control in the postoperative period,
- Patients had a VAS pain level of 4 or above, had no foot pain
- Patients who did not have wounds, infections or infectious diseases
Key exclusion criteria (2 listed)
- Patients who developed any complications before, during or after surgery
- Patients who had drains were not included 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 |
|---|---|---|
| foot bathOn the morning of surgery, the purpose of the study will be explained to the patients and their written consent will be obtained. Then, Introductory Information Form, STAI and VASS were applied. The pain level of the patients will be evaluated with VAS-Pain 4 hours after the surgery. SAI and VAS-Comfort will be applied to patients with pain level 4 and above. Then, patients in the experimental group will receive a hot water foot bath for 20 minutes. Before the hot water foot bath, patients will be lifted from their beds and placed on the chair in the room. Hot water will be poured into the foot bath tub and the patient will be asked to put his feet in the water. The water level will be adjusted to include the patients ankles. The temperature of the water will be constantly checked with a water thermometer and kept at 41-42 °C. A hot water foot bath will be applied for 20 minutes and then the patients feet will be dried with a towel. | Other | intervention group |
Primary outcome
Visual Analog pain scale
Time frame: 4 hours after the surgery, after the application at the 5th, 30th, 60th and 120th minutes.
Zero is equivalent to no pain and 10 indicates the worst possible pain.
Visual Analog Comfort scale
Time frame: 4 hours after the surgery, after the application at the 5th, 30th, 60th and 120th minutes.
Zero is equivalent to no comfort and 10 indicates the worst possible comfort.
Visual Analog Sleep Scale
Time frame: On the surgery morning, first day after surgery.
Zero is equivalent to the best sleep and 1000 indicates the worst possible sleep.
The State-Trait Anxiety Inventory Form (STAI)
Time frame: 4 hours after the surgery, after the application at the 5th, 30th, 60th and 120th minutes.
20 is equivalent to no anxiety and 80 indicates the worst possible anxiety.
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 11 Dec 2025.
- Individual participant dataSharing planned: No
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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.
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 in people with Laparoscopic Cholecystectomy, run by Dilek GÜRÇAYIR 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 6 inclusion and 2 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 11 Dec 2025. 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?
Visual Analog pain scale (time frame: 4 hours after the surgery, after the application at the 5th, 30th, 60th and 120th minutes.). The study lists 4 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 Dec 2025.