The Effect of Abdominal Massage and Warm Application on Excretory Activity in Patients Undergoing Total Knee Replacement With Spinal Anesthesia

NCT06578936 | Recruiting DMC

• 1 other identifier: MU-DEMIRTAS-01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

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.

Conditions

Total Knee Replacement

Keywords

heat application; constipation; intestinal motility; spinal anesthesia

Outcome Measures

Primary Outcomes (2)

• time for bowel sounds to return

  The time of return of bowel sounds in the morning and evening will be assessed and recorded on the Excretory Activities Form.

  1-3.days

• time to defecate

  the effect of abdominal massage and warm application on defecation time after total knee replacement

  1-3.day

Secondary Outcomes (2)

• risk of constipation

  1-3.days

• laxative use

  1-3.days

Study Arms (2)

abdominal massage and warm application group

EXPERIMENTAL

The experimental group will receive abdominal massage and warm application 2 times a day, morning and evening, until defecation, starting from the evening of the first day after the surgical intervention.

Other: abdominal massage andwarm application

control group

NO INTERVENTION

In the control group, bowel sounds will be listened during hot application and abdominal massage hours, daily laxative use will be determined and recorded in the Excretory Activity Form.

Interventions

abdominal massage andwarm application OTHER

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 and warm application group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written and verbal permission was obtained to participate in the study,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ayşe Demirtaş: lead

Study Sites (2)

Adana city hospital

Adana, Turkey (Türkiye)

RECRUITING

Mersin Univercity

Mersin, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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.

  PMID: 31879495 RESULT

• 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.

  PMID: 33185695 RESULT

• 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.

  PMID: 36058824 RESULT

• 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.

  PMID: 16624632 RESULT

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• gülay altun uğraş, PhD

  mersin univercity

  STUDY DIRECTOR

Central Study Contacts

ayse demirtas

CONTACT

3224559000; aysedemirtas0612@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: A biostatistician who is not involved in the study will be randomly assigned to groups A and B, which are formed by a biostatistician in the computer environment. As a result of the draw of lots, whether group A and B will be the study or control group will be determined by a coin toss at the beginning of the study. The information showing that the patients included in the research sample are assigned to groups A and B according to the randomization table will be placed in an opaque envelope. This envelope will be kept by the coordinator researcher (GAU), and when the researcher (AD) goes to the patient for the application, he/she will open the envelope after filling out the "Informed Consent Form" and learn which group the patient is in
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: student researcher

Model Details: A prospective, parallel, two-arm, randomized controlled clinical trial

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 30, 2024
• Study Start: August 5, 2024
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)