Clinical trial NCT06578936: The Effect of Abdominal Massage and Warm Application on Excretory Activity in Patients Undergoing Total Knee Replacement With Spinal Anesthesia
Official title: The Effect of Abdominal Massage and Warm Application on Excretory Activity in Patients Undergoing Total Knee Replacement With Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Total Knee Replacement
Keywords: heat application
constipation
intestinal motility
spinal anesthesia
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, parallel, two-arm, randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to determine the effect of abdominal massage and warm application on the excretory activity (time of first bowel sounds, defecation time and the amount of laxative used until discharge) after total knee replacement surgery performed with spinal anesthesia.

Detailed description: Abdominal massage and hot application will be applied to the patients at least 30 minutes after the morning and evening meals (08:30 am, 20:30 pm) for 15 minutes each, similar to the literature. The hot application will be applied to the abdominal area with a hot water thermophore for 15 minutes before the abdominal massage. After the hot application, abdominal massage will be started. In the abdominal massage, which will be applied clockwise to stimulate bowel movements, four basic movements will be used: superficial exertion, deep exertion, petrisage and vibration. Abdominal massage will be applied to the patients in accordance with the Abdominal Massage Application Checklist created by the researcher in line with the literature.

Warm application and abdominal massage will be applied to the study group from the first evening of the total knee replacement procedure, and the application will continue in the morning and evening hours until the first defecation. After the application, bowel sounds will be listened to in accordance with the application steps. In the control group, bowel sounds will be listened to at times corresponding to the hours of hot application and abdominal massage, daily laxative use will be determined and recorded in the Excretory Activity Form.

Eligibility criteria: Inclusion Criteria:

* Written and verbal permission was obtained to participate in the study,
* 18 years of age or older,
* Conscious, oriented and cooperative,
* Speaks and understands Turkish,
* Total knee replacement with spinal anesthesia planned,
* No condition in which abdominal massage is contraindicated (inflammatory bowel disease, presence of abdominal tumors, surgical intervention or radiotherapy to the abdominal area, presence or suspicion of ileus, and pregnancy),
* No physician-diagnosed chronic constipation,
* Mobilized,
* Patients who do not have problems with transition to oral feeding and can be fed orally will be included.

Exclusion Criteria:

* Written and verbal permission to participate in the research could not be obtained,
* Under 18 years of age,
* Unconscious, disoriented and uncooperative,
* Can speak Turkish but cannot understand it,
* Total knee replacement with general anesthesia planned,
* Any condition in which abdominal massage is contraindicated (inflammatory bowel disease, presence of abdominal tumors, surgical intervention or radiotherapy to the abdominal area, presence or suspicion of ileus, and pregnancy),
* Physician-diagnosed chronic constipation,
* Non-mobilized,
* Patients who have problems with transition to oral feeding and who cannot be fed orally will not be included.

Primary outcomes:
measure: time for bowel sounds to return
timeFrame: 1-3.days
measure: time to defecate
timeFrame: 1-3.day
Secondary outcomes:
measure: risk of constipation
timeFrame: 1-3.days
measure: laxative use
timeFrame: 1-3.days
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Adana city hospital
city: Mersin
country: Turkey
facility: Mersin Univercity
Study officials:
affiliation: mersin univercity
name: gülay altun uğraş, PhD
role: STUDY_DIRECTOR
References:
citation: Axelby E, Kurmis AP. Gabapentoids in knee replacement surgery: contemporary, multi-modal, peri-operative analgesia. J Orthop. 2019 Jul 2;17:150-154. doi: 10.1016/j.jor.2019.06.031. eCollection 2020 Jan-Feb.
citation: Jaber A, Hemmer S, Klotz R, Ferbert T, Hensel C, Eisner C, Ryang YM, Obid P, Friedrich K, Pepke W, Akbar M. Bowel dysfunction after elective spinal surgery: etiology, diagnostics and management based on the medical literature and experience in a university hospital. Orthopade. 2021 Jun;50(6):425-434. doi: 10.1007/s00132-020-04034-z.
citation: Aydinli A, Karadag S. "Effects of abdominal massage applied with ginger and lavender oil for elderly with constipation: A randomized controlled trial". Explore (NY). 2023 Jan-Feb;19(1):115-120. doi: 10.1016/j.explore.2022.08.010. Epub 2022 Aug 20.
citation: Nagashima Y, Oda H, Igaki M, Suzuki M, Suzuki A, Yada Y, Tsuchiya S, Suzuki T, Ohishi S. Application of heat- and steam-generating sheets to the lumbar or abdominal region affects autonomic nerve activity. Auton Neurosci. 2006 Jun 30;126-127:68-71. doi: 10.1016/j.autneu.2006.02.002. Epub 2006 Mar 6.