Effect of Foot Bath on Postoperative Sleep Quality and Pain

Sponsor

Acibadem University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05705908

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Nursing Caries Pain, Postoperative Sleep Deprivation	Other: Hot Foot Bath 1 Other: Hot Foot Bath 2	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized controlled trialrandomized controlled trial

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Effect of Foot Bath Using Warm Water and Lavender Essential Oil on Postoperative Sleep Quality and Pain: A Randomized Controlled Study

Actual Study Start Date :

Oct 15, 2021

Anticipated Primary Completion Date :

Apr 15, 2023

Anticipated Study Completion Date :

Apr 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Group - No foot bath 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: Experimental Group- Hot Foot Bath 1 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 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: Experimental Group- Hot Foot Bath 2 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 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

Arm

Intervention/Treatment

No Intervention: Control Group - No foot bath

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: Experimental Group- Hot Foot Bath 1

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

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: Experimental Group- Hot Foot Bath 2

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.