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

NCT ID: NCT06578936

Last Updated: 2024-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-05

Study Completion Date

2025-06-30

Brief Summary

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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

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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.

Conditions

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Total Knee Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective, parallel, two-arm, randomized controlled clinical trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
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

Study Groups

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abdominal massage and warm application group

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.

Group Type EXPERIMENTAL

abdominal massage andwarm application

Intervention Type 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.

control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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abdominal massage andwarm application

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ayşe Demirtaş

OTHER

Sponsor Role lead

Responsible Party

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Ayşe Demirtaş

student researcher

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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gülay altun uğraş, PhD

Role: STUDY_DIRECTOR

mersin univercity

Locations

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Adana city hospital

Adana, , Turkey (Türkiye)

Site Status RECRUITING

Mersin Univercity

Mersin, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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ayse demirtas

Role: CONTACT

3224559000 ext. 2502

Facility Contacts

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Ayse DEMIRTAS

Role: primary

3224559000 ext. 2502

Ayse DEMIRTAS

Role: primary

3224559000 ext. 2502

References

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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.

Reference Type RESULT
PMID: 31879495 (View on PubMed)

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.

Reference Type RESULT
PMID: 33185695 (View on PubMed)

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.

Reference Type RESULT
PMID: 36058824 (View on PubMed)

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.

Reference Type RESULT
PMID: 16624632 (View on PubMed)

Other Identifiers

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MU-DEMIRTAS-01

Identifier Type: -

Identifier Source: org_study_id

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