Skip to main content
Clinical Trials/NCT06177873
NCT06177873
Completed
Not Applicable

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

Dilek GÜRÇAYIR1 site in 1 country108 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Laparoscopic Cholecystectomy
Sponsor
Dilek GÜRÇAYIR
Enrollment
108
Locations
1
Primary Endpoint
Visual Analog Comfort scale
Status
Completed
Last Updated
4 months ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
November 30, 2022
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Dilek GÜRÇAYIR

Assistant professor

Ataturk University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

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.

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.

Study Sites (1)

Loading locations...

Similar Trials