Total Knee ReplacementAbdominalNCT06578936
The Effect of Abdominal Massage and Warm Application on Excretory Activity in Patients Undergoing Total Knee Replacement With Spinal Anesthesia
A study testing abdominal massage andwarm application in people with Total Knee Replacement, run by Ayşe Demirtaş at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- abdominal massage andwarm application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 5 Aug 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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),
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- 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.
Who cannot join
- 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),
Show all 9Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Adana city hospital
Adana
Ayse DEMIRTAS, 3224559000 ext. 2502, aysedemirtas0612@gmail.com
Doç.Dr. G ALTUN UĞRAS
- Recruiting
Mersin Univercity
Mersin
Ayse DEMIRTAS, 3224559000 ext. 2502, aysedemirtas0612@gmail.com
About this study
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.
Read the 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.
- Conditions
- Total Knee Replacement
- Being tested
- abdominal massage andwarm application
- Keywords
- heat application, constipation, intestinal motility, spinal anesthesia
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal massage andwarm applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-3.days
time to defecate
the effect of abdominal massage and warm application on defecation time after total knee replacement
Measured: 1-3.day
Secondary outcomes (2)
risk of constipation
postoperative defecation status will be recorded on the excretory activity form and the risk of constipation will be assessed
Measured: 1-3.days
laxative use
The amount of medication used to facilitate defecation is assessed in the morning and evening and recorded on the Excretory Activities Form.
Measured: 1-3.days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start5 Aug 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, parallel, two-arm, randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ayşe Demirtaş
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayşe Demirtaş, Mersin University
- Investigators
- gülay altun uğraş, PhD, Study director, mersin univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578936
- Sponsor's protocol ID
- MU-DEMIRTAS-01
- Acronym
- Abdominal
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31879495Jaber 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.
PubMed 33185695Aydinli 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.
PubMed 36058824Nagashima 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.
PubMed 16624632
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Abdominal Massage and Warm Application on Excretory Activity in Patients Undergoing Total Knee Replacement With Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT06578936
- Acronym / sponsor ID
- Abdominal / MU-DEMIRTAS-01
- Conditions
- Total Knee Replacement
- Keywords
- heat application, constipation, intestinal motility, spinal anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Ayşe DemirtaşUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A prospective, parallel, two-arm, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| abdominal massage and warm application group | Experimental | Other: abdominal massage andwarm applicationThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abdominal massage andwarm applicationAbdominal 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. | Other | abdominal massage and warm application group |
Primary outcome
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.
time to defecate
Time frame: 1-3.day
the effect of abdominal massage and warm application on defecation time after total knee replacement
2 secondary outcomes
risk of constipation
Time frame: 1-3.days
laxative use
Time frame: 1-3.days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Results publication: PubMed 31879495Axelby 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.
- Results publication: PubMed 33185695Jaber 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.
- Results publication: PubMed 36058824Aydinli 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.
- Results publication: PubMed 16624632Nagashima 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
gülay altun uğraş, PhD study director
mersin univercity
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing abdominal massage andwarm application in people with Total Knee Replacement, run by Ayşe Demirtaş at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ayse demirtas (3224559000 ext. 2502, aysedemirtas0612@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time for bowel sounds to return (time frame: 1-3.days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06578936, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.