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

Laparoscopic Cholecystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06177873
• Other study ID #: 501100004951
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2, 2023
• Est. completion date: March 2024

Study information

• Verified date: December 2023
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Gallstones constitute one of the most common problems of the digestive system. In patients with gallstone-related symptoms, medical treatment usually fails and cholecystectomy is indicated. Open cholecystectomy has long been used as standard treatment in the treatment of symptomatic gallstones. Today, laparoscopic cholecystectomy is preferred in the surgical treatment of gallstones with a rate of 90% due to advantages such as small incision, less pain, shorter hospital stay and lower costs.

Laparoscopic cholecystectomy has some risks because it is an intervention performed under general anesthesia. Pain, which is experienced at different levels in all patients in the postoperative period, has an important place in the care process of patients. Because inadequate pain management in the early postoperative period causes patients to prolong their recovery process and increase the risk of complications. Anxiety plays an important role in the increase and decrease of pain after surgical intervention. Studies show that anxiety increases the severity of pain and that more opioids are needed after surgery. For this reason, it is recommended to evaluate acute pain and anxiety together.

Increased pain and anxiety levels after surgery may also negatively affect patients; sleep quality. Sleep is a basic human need essential for physical and psychological well-being. Insufficient and low quality sleep causes various physiological effects such as disorders in the immune system, increased sensitivity to pain, decrease in forced expiratory volume, increase in sympathetic activity and decrease in parasympathetic activity. Postoperative pain, anxiety, and insomnia may also negatively affect patients' comfort level. Increasing patients; pain management, sleep quality and comfort levels in the postoperative period is very important for the physical and psychological well-being of patients. In this context, early evaluation and diagnosis of pain and anxiety, which are common in laparoscopic cholecystectomy, and planning of individual-specific nursing interventions are among the basic responsibilities of the nurse.

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 is examined, it is seen that hot foot bath is effective in anxiety, pain, and anxiety after laparoscopic cholecystectomy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 108
• Est. completion date: March 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

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.

Locations

Country	Name	City	State
Turkey	Ataturk University	Erzurum	Yakutiye

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.