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CompletedNCT06177873Updated Dec 11, 2025

Effect of Foot Bath on Pain, Anxiety, Sleep and Comfort Level

An interventional study of foot bath in Laparoscopic Cholecystectomy, sponsored by Dilek GÜRÇAYIR. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-11.

Sponsored by Dilek GÜRÇAYIR · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Jan 2022, registered Nov 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Laparoscopic Cholecystectomy

Keywords

  • foot bath
  • pain
  • anxiety
  • comfort
  • sleep
03

In context

Pain

2,219 studies on the registry are indexed under Pain; 917 are open to participants now.

This study's enrollment of 108 is above the median of 70 across 1,904 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Dilek GÜRÇAYIR is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Patients who developed any complications before, during or after surgery
  • Patients who had drains were not included in the study.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
108 participants (actual)

Study arms

  • Experimental
    intervention group

    Hot water foot bath will applied to intervention group.

    Other: foot bath

  • No intervention
    control group

    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.

Interventions

  • Otherfoot bath

    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.

06

What researchers measure

Primary outcomes

  1. Visual Analog pain scale

    Zero is equivalent to no pain and 10 indicates the worst possible pain.

    Time frame: 4 hours after the surgery, after the application at the 5th, 30th, 60th and 120th minutes.

  2. Visual Analog Comfort scale

    Zero is equivalent to no comfort and 10 indicates the worst possible comfort.

    Time frame: 4 hours after the surgery, after the application at the 5th, 30th, 60th and 120th minutes.

  3. Visual Analog Sleep Scale

    Zero is equivalent to the best sleep and 1000 indicates the worst possible sleep.

    Time frame: On the surgery morning, first day after surgery.

  4. The State-Trait Anxiety Inventory Form (STAI)

    20 is equivalent to no anxiety and 80 indicates the worst possible anxiety.

    Time frame: 4 hours after the surgery, after the application at the 5th, 30th, 60th and 120th minutes.

07

Study locations

1 site
  • Atatürk University
    Erzurum, Yakutiye 25240, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06177873
Lead sponsor
Dilek GÜRÇAYIR
Responsible party
Dilek GÜRÇAYIR (Assistant professor, Ataturk University) — Sponsor-investigator
First posted
Dec 20, 2023
Start date
Jan 1, 2022
Primary completion
Nov 30, 2022
Completion
Nov 30, 2022
Last update
Dec 11, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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