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Effect of Foot Bath on Postoperative Sleep Quality and Pain

Primary Purpose

Nursing Caries, Pain, Postoperative, Sleep Deprivation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hot Foot Bath 1
Hot Foot Bath 2
Sponsored by
Acibadem University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Nursing Caries focused on measuring Sleep quality, pain management, post-operative care, foot bath

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 18 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. Exclusion Criteria: 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.

Sites / Locations

  • Yasemin Uslu

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control Group - No foot bath

Experimental Group- Hot Foot Bath 1

Experimental Group- Hot Foot Bath 2

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change between Sleep Scale Score
Richard-Campbell Sleep Scale: This scale consists of 6 items that evaluate the depth of night sleep, the time to fall asleep, the frequency of awakening, the time to stay awake when awakened, the quality of sleep and the noise level of the environment. Each item is evaluated on a chart between 0 and 100 using the visual analog scale technique. According to the scale, the score in the range of "0-25" indicates very bad sleep, and the score in the range of "76-100" indicates very good sleep. Sleep Scale was administered at 08:00-09:00 in the morning (when the patient woke up) in hospital - 3 times. Immediately after surgery means 0th hour. These times; post-operative 24th Hour, 48th Hour, 72th Hour. It will be measured for the last time at 72 hours and data collection will be finished here

Full Information

First Posted
May 25, 2022
Last Updated
July 21, 2023
Sponsor
Acibadem University
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1. Study Identification

Unique Protocol Identification Number
NCT05705908
Brief Title
Effect of Foot Bath on Postoperative Sleep Quality and Pain
Official Title
Effect of Foot Bath Using Warm Water and Lavender Essential Oil on Postoperative Sleep Quality and Pain: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
July 19, 2023 (Actual)
Study Completion Date
July 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Acibadem University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
It was planned as a randomized controlled trial. The population of the study consisted of patients who underwent abdominal surgery in the General Surgery Service of a private health group hospital in Istanbul. Patients who met the inclusion criteria constituted the sample. "Visual Comparison Scale-VAS" and "Richard-Campbell Sleep Scale" were used during data collection. Visual Comparison Scale-VAS: It is a scale that starts with no pain and ends with unbearable. The 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. Richard-Campbell Sleep Scale: This scale consists of 6 items that evaluate the depth of night sleep, the time to fall asleep, the frequency of awakening, the time to stay awake when awakened, the quality of sleep and the noise level of the environment. Each item is evaluated on a chart between 0 and 100 using the visual analog scale technique. According to the scale, the score in the range of "0-25" indicates very bad sleep, and the score in the range of "76-100" indicates very good sleep. Foot bath was started as of the 24th hour after the operation. During the 3 days they were hospitalized, they had a foot bath evening before going to sleep (experimental group). Routine service applications were performed in the control group. In order to ensure the comfort of the experimental and control group patients and to minimize their exposure to the external environment, the patient rooms were kept clean, at a suitable temperature (23-25 degrees) and quiet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nursing Caries, Pain, Postoperative, Sleep Deprivation
Keywords
Sleep quality, pain management, post-operative care, foot bath

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group - No foot bath
Arm Type
No Intervention
Arm Description
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.
Arm Title
Experimental Group- Hot Foot Bath 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Experimental Group- Hot Foot Bath 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Hot Foot Bath 1
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Hot Foot Bath 2
Intervention Description
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
Primary Outcome Measure Information:
Title
Change between Post-operative Pain Score
Description
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
Time Frame
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 Outcome Measure Information:
Title
Change between Sleep Scale Score
Description
Richard-Campbell Sleep Scale: This scale consists of 6 items that evaluate the depth of night sleep, the time to fall asleep, the frequency of awakening, the time to stay awake when awakened, the quality of sleep and the noise level of the environment. Each item is evaluated on a chart between 0 and 100 using the visual analog scale technique. According to the scale, the score in the range of "0-25" indicates very bad sleep, and the score in the range of "76-100" indicates very good sleep. Sleep Scale was administered at 08:00-09:00 in the morning (when the patient woke up) in hospital - 3 times. Immediately after surgery means 0th hour. These times; post-operative 24th Hour, 48th Hour, 72th Hour. It will be measured for the last time at 72 hours and data collection will be finished here
Time Frame
Post-operative change between sleep scale score; 24th Hour, 48th Hour, 72th Hour (data collection will be finished here)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasemin Uslu, Asisst Prof
Organizational Affiliation
Acıbadem Mehmet Ali Aydınlar Üniversitesi
Official's Role
Study Chair
Facility Information:
Facility Name
Yasemin Uslu
City
İstanbul
State/Province
Ataşehir
ZIP/Postal Code
34752
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34419870
Citation
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.
Results Reference
result
PubMed Identifier
31598506
Citation
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.
Results Reference
result
PubMed Identifier
25276739
Citation
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.
Results Reference
result
PubMed Identifier
29787355
Citation
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.
Results Reference
result
PubMed Identifier
27261980
Citation
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.
Results Reference
result

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Effect of Foot Bath on Postoperative Sleep Quality and Pain

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