Effect of Foot Bath on Postoperative Sleep Quality and Pain

NCT05705908 | Completed

• 1 other identifier: ATADEK 2021-19/19
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

One of the most common problems in patients in the postoperative period is pain and the associated deterioration in sleep quality. Deterioration in sleep quality can cause pain to be perceived more severely. It is recommended to use non-pharmacological approaches as well as pharmacological interventions in the management of these problems. This study was planned to determine the effect of hot foot bath and lavender essential oil foot bath application on postoperative sleep quality and pain in patients undergoing abdominal surgery.

Conditions

Nursing Caries; Pain, Postoperative; Sleep Deprivation

Keywords

Sleep quality; pain management; post-operative care; foot bath

Outcome Measures

Primary Outcomes (1)

• Change between Post-operative Pain Score

  The Pain scale - VAS scale consists of a 10 cm long line. At one end of the line, "no pain" signals what may be at the other end of the "unbearable pain." The patient is asked to point to a point that indicates the current level of pain. The difference between pain scores over 3 days will be evaluated in hospital Patient's pain was evaluated with VAS - 14 times after surgery. Immediately after surgery means 0th hour. These times; post-operative 24th hour, 28th hour, 32nd hour, 36th hour, 40th hour, 44th hour, 48th hour, 52nd hour, 56th hour, 58th hour, 62nd Hour, 64th Hour., 68th Hour, 72nd Hour. It will be measured for the last time at 72 hours and data collection will be finished here

  Post-operative Change between Pain Score; 24th hour, 28th hour, 32nd hour, 36th hour, 40th hour, 44th hour, 48th hour, 52nd hour, 56th hour, 58th hour, 62nd Hour, 64th Hour, 68th Hour, 72nd Hour (data collection will be finished here)

Secondary Outcomes (1)

• Change between Sleep Scale Score

  Post-operative change between sleep scale score; 24th Hour, 48th Hour, 72th Hour (data collection will be finished here)

Study Arms (3)

Control Group - No foot bath

NO INTERVENTION

* 24 hours after surgery - did not give foot bath to patients * Pain was evaluated with VAS scale. Post-operative 24th hour, 28th hour, 32nd hour, 36th hour, 40th hour, 44th hour, 48th hour, 52nd hour, 56th hour, 58th hour, 62nd Hour, 64th Hour., 68th Hour, 72nd Hour * Sleep Questionnaire was administered at 08:00-09:00 in the morning when the patient woke up; 24th hour, 48 th hour, 72 th hour.

Experimental Group- Hot Foot Bath 1

EXPERIMENTAL

* Post operative 24th hour - 48 th hour - 72 nd hour - gave patients hot foot bath * Patient was seated in an upright position. * FM 4020 Grundig brand footbath device was used for the Hot Foot Bath. * It was filled with 40 degrees water, 20 cm (4 lt. of water) * Soaked in hot water up to the ankles * The foot bath was continued for 20 minutes with the feet in the device. * After 20 minutes, the patient's feet were dried with a towel. * After the foot bath pain was evaluated with VAS scale. Post-operative 24th hour, 28th hour, 32nd hour, 36th hour, 40th hour, 44th hour, 48th hour, 52nd hour, 56th hour, 58th hour, 62nd Hour, 64th Hour., 68th Hour, 72nd Hour * Sleep Questionnaire was administered at 08:00-09:00 in the morning when the patient woke up; 24th hour, 48 th hour, 72 th hour.

Other: Hot Foot Bath 1

Experimental Group- Hot Foot Bath 2

EXPERIMENTAL

* Post operative 24th hour - 48 th hour - 72 nd hour - gave patients hot foot bath with Lavender Essential Oil * Patient was seated in an upright position. * FM 4020 Grundig brand footbath device was used for the Hot Foot Bath. * It was filled with 40 degrees water, 20 cm (4 lt. of water) * Soaked in hot water up to the ankles * The foot bath with Lavender Essential Oil was continued for 20 minutes with the feet in the device. * After 20 minutes, the patient's feet were dried with a towel. * After the foot bath with Lavender Essential Oil pain was evaluated with VAS scale. Post-operative 24th hour, 28th hour, 32nd hour, 36th hour, 40th hour, 44th hour, 48th hour, 52nd hour, 56th hour, 58th hour, 62nd Hour, 64th Hour., 68th Hour, 72nd Hour * Sleep Questionnaire was administered at 08:00-09:00 in the morning when the patient woke up; 24th hour, 48 th hour, 72 th hour.

Other: Hot Foot Bath 2

Interventions

Hot Foot Bath 1 OTHER

* Hot foot bath device has a built-in heater (max. 44°C), * Hot foot bath device has anti-slip base, vibration and 2 rotating massage rollers, digital display/control panel and timer (20-60 minutes). * It is filled with water at 40 degrees so that it passes the ankle of the patient by 20 cm (4 liters of water).

Experimental Group- Hot Foot Bath 1

Hot Foot Bath 2 OTHER

* Hot foot bath device has a built-in heater (max. 44°C), * Hot foot bath device has anti-slip base, vibration and 2 rotating massage rollers, digital display/control panel and timer (20-60 minutes). * It is filled with water at 40 degrees so that it passes the ankle of the patient by 20 cm (4 liters of water). * 3 drops of lavender essential oil were dripped in the water

Experimental Group- Hot Foot Bath 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and over
• Electively planned robotic and laparoscopic abdominal (colorectal, hepatobiliary, gastric and esophageal surgery, bariatric surgery, peritoneal membrane cancer) surgical operations
• Surgeries performed under general anesthesia
• Patients who have been hospitalized for at least 3 days after surgery
• Patients without a detected sleep disorder (Patients with Insomnia Severity Index score between 0-7) will be included in the study.

You may not qualify if:

• Patients who constantly take a foot bath
• Emergency surgeries
• Those with literacy disabilities
• Those with physical and mental disabilities
• Patients with diabetes for more than 10 years
• Patients with diabetic foot, neuropathy, foot pressure sores or any skin disease on their feet
• Those with vascular diseases
• Those who are allergic to lavender
• Those with neurological diseases (dementia, alzheimer, etc.)
• Those who regularly use sleep and psychoactive drugs
• Those who use drugs that affect sleep during hospitalization (sedatives, etc.)
• Patients who were transferred to the post-operative revision or general intensive care unit will not be included in the study.

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Yasemin Uslu

Istanbul, Ataşehir, 34752, Turkey (Türkiye)

Location

Related Publications (5)

• Armat MR, Mortazavi H, Akbari H, Ebrahimzadeh Z. The effect of footbath on the quality of sleep in older adults: A pilot study. Geriatr Nurs. 2021 Sep-Oct;42(5):1178-1183. doi: 10.1016/j.gerinurse.2021.07.008. Epub 2021 Aug 20.

  PMID: 34419870 RESULT

• Talebi Ghadicolaei H, Heydary Gorji MA, Bagheri B, Yazdani Charati J, Hadinejad Z. The Effect of Warm Footbath on the Quality of Sleep on Patients with Acute Coronary Syndrome in Cardiac Care Unit. J Caring Sci. 2019 Sep 1;8(3):137-142. doi: 10.15171/jcs.2019.020. eCollection 2019 Sep.

  PMID: 31598506 RESULT

• Seyyedrasooli A, Valizadeh L, Zamanzadeh V, Nasiri K, Kalantri H. The effect of footbath on sleep quality of the elderly: a blinded randomized clinical trial. J Caring Sci. 2013 Nov 30;2(4):305-11. doi: 10.5681/jcs.2013.036. eCollection 2013 Dec.

  PMID: 25276739 RESULT

• Effati-Daryani F, Mohammad-Alizadeh-Charandabi S, Mirghafourvand M, Taghizadeh M, Bekhradi R, Zarei S. Effect of Lavender cream with or without footbath on sleep quality and fatigue in pregnancy and postpartum: a randomized controlled trial. Women Health. 2018 Nov-Dec;58(10):1179-1191. doi: 10.1080/03630242.2017.1414101. Epub 2018 May 22.

  PMID: 29787355 RESULT

• Kim HJ, Lee Y, Sohng KY. The effects of footbath on sleep among the older adults in nursing home: A quasi-experimental study. Complement Ther Med. 2016 Jun;26:40-6. doi: 10.1016/j.ctim.2016.02.005. Epub 2016 Feb 15.

  PMID: 27261980 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Sleep Deprivation; Sleep Initiation and Maintenance Disorders; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Perceptual Disorders; Neurobehavioral Manifestations

Study Officials

• Yasemin Uslu, Asisst Prof

  Acıbadem Mehmet Ali Aydınlar Üniversitesi

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asisst. Prof.

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: January 31, 2023
• Study Start: May 15, 2021
• Primary Completion: July 19, 2023
• Study Completion: July 19, 2023
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)