- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06578936
The Effect of Abdominal Massage and Warm Application on Excretory Activity in Patients Undergoing Total Knee Replacement With Spinal Anesthesia (Abdominal)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ayse DEMIRTAS
- Phone Number: 2502 3224559000
- Email: aysedemirtas0612@gmail.com
Study Locations
-
-
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Adana, Turkey
- Recruiting
- Adana City Hospital
-
Contact:
- Ayse DEMIRTAS
- Phone Number: 2502 3224559000
- Email: aysedemirtas0612@gmail.com
-
Principal Investigator:
- Doç.Dr. G ALTUN UĞRAS
-
Sub-Investigator:
- Ayse A DEMİRTAS
-
Mersin, Turkey
- Recruiting
- Mersin Univercity
-
Contact:
- Ayse DEMIRTAS
- Phone Number: 2502 3224559000
- Email: aysedemirtas0612@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
time for bowel sounds to return
Time Frame: 1-3.days
|
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
Time Frame: 1-3.day
|
the effect of abdominal massage and warm application on defecation time after total knee replacement
|
1-3.day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
risk of constipation
Time Frame: 1-3.days
|
postoperative defecation status will be recorded on the excretory activity form and the risk of constipation will be assessed
|
1-3.days
|
|
laxative use
Time Frame: 1-3.days
|
The amount of medication used to facilitate defecation is assessed in the morning and evening and recorded on the Excretory Activities Form.
|
1-3.days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: gülay altun uğraş, PhD, Mersin Univercity
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MU-DEMIRTAS-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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