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

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Cholecystectomy
• Intervention / Treatment: Other: foot bath

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 Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Yakutiye
    • Erzurum, Yakutiye, Turkey (Türkiye), 25240
      • Ataturk University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; Hot water foot bath will applied to intervention group.	Other: foot 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog pain scale	Zero is equivalent to no pain and 10 indicates the worst possible pain.	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.	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.	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.	4 hours after the surgery, after the application at the 5th, 30th, 60th and 120th minutes.

Collaborators and Investigators

• Sponsor: Dilek GÜRÇAYIR

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: December 10, 2023
• First Posted (Actual): December 20, 2023

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: pain; sleep; comfort; anxiety; foot bath
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anxiety Disorders
• Other Study ID Numbers: 501100004951

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No