Clinical trial NCT05705908: 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
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Caries
Pain, Postoperative
Sleep Deprivation
Keywords: Sleep quality
pain management
post-operative care
foot bath
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Change between Post-operative Pain Score
timeFrame: 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:
measure: Change between Sleep Scale Score
timeFrame: Post-operative change between sleep scale score; 24th Hour, 48th Hour, 72th Hour (data collection will be finished here)
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Yasemin Uslu
state: Ataşehir
Study officials:
affiliation: Acıbadem Mehmet Ali Aydınlar Üniversitesi
name: Yasemin Uslu, Asisst Prof
role: STUDY_CHAIR
References:
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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.