- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05127577
Effect of Abdominal Massage on Excretory Activity and Pulmonary Function Tests in Patients After Surgery
March 14, 2023 updated by: Canan KANAT, Mersin University
Effect of Abdominal Massage on Excretory Activity and Pulmonary Function Tests in Patients With Partial Hip Replacement
This study is aimed to determine the effect of abdominal massage on excretory activity and pulmonary function tests (PFT) in patients undergoing PKP.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Methods: The research will be carried out with 78 patients who underwent partial hip replacement.
Patients were assigned to study (abdominal massage) and control groups by randomization.
Abdominal massage will be applied to the patients at least 30 minutes after the morning and evening meals (08:30 in the morning, 20:30 in the evening) for 15 minutes, similar to the literature.
Patients' data will be collected 15 minutes before and after the application of abdominal massage.
Within the scope of the patient's data, information on pulmonary function test values, intra-abdominal pressure value and excretory activities will be collected.
Abdominal massage will start in the evening of the day the patient is transferred to the clinic (20:30), and will be terminated when the patient defecates.
No treatment will be applied to the patients in the control group.
The data recorded before and after the abdominal massage in the study group will be recorded in the Excretory Activity Form and the Pulmonary Function Test Form as a result of the measurements made at the same time in the control group.
Study Type
Interventional
Enrollment (Actual)
78
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Mersin, Turkey
- Mersin Univercity
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Having a urinary catheter for at least one day after surgery,
- Discharged at least 48 hours after surgery,
- Do not have any condition for which abdominal massage is contraindicated (inflammatory bowel disease, presence of abdominal tumor, surgical intervention or radiotherapy to the abdominal region, presence or suspicion of ileus, and pregnancy),
- No diagnosis of chronic constipation made by a physician,
- Who has not developed any respiratory tract complications (atelectasis, pneumonia, etc.) due to surgical intervention,
- No chronic respiratory disease (chronic obstructive pulmonary disease, pulmonary hypertension, sleep apnea syndrome, asthma, chronic bronchitis, cystic fibrosis, occupational lung diseases, etc.),
- Patients who do not have problems in transition to oral feeding and who can be fed orally will be included in the study.
Exclusion Criteria:
- Urinary catheter removed within the first day after surgery,
- Discharged before 48 hours after surgery,
- Any condition in which abdominal massage is contraindicated (inflammatory bowel disease, presence of abdominal tumor, surgical intervention or radiotherapy to the abdominal region, presence or suspicion of ileus, and pregnancy),
- Having a diagnosis of constipation made by a physician,
- Having any respiratory complications (atelectasis, pneumonia, etc.) developed due to surgical intervention,
- Having chronic respiratory disease (chronic obstructive pulmonary disease, pulmonary hypertension, sleep apnea syndrome, asthma, chronic bronchitis, cystic fibrosis, occupational lung diseases, etc.),
- Patients who have problems in the transition to oral feeding and cannot be fed orally will not be included in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|
|
No Intervention: Control group
The control group will be received routine treatment and care in the unit.
|
|
|
Experimental: Abdominal massage group
Abdominal massage will be applied to the experimental group 2 times a day, morning and evening, until defecation, starting in the evening of the first day after the surgical intervention.
|
Abdominal massage will be applied to patients at least 30 minutes after morning and evening meals (8:30 in the morning, 20:30 in the evening) for 15 minutes each, similar to the literature [33,34,38].
Data of the patients will be collected again 15 minutes after the application of abdominal massage (09:00-09:15 in the morning, 21:00-21:15 in the evening).
Abdominal massage will start in the evening of the day the patient is transferred to the clinic (20:30), and will be terminated when the patient defecates.
In order to stimulate bowel movements, four basic movements will be used in the abdominal massage to be applied clockwise: superficial effusion, deep effusion, petrissage, and vibration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intra-abdominal Pressure Value
Time Frame: up to first defecation an average of 3 days
|
Intra-abdominal pressure measurement will be performed using the existing urinary catheter in the patient.
This measurement method, which is performed through the bladder, is accepted as the gold standard for intra-abdominal pressure measurement because it is an easy-to-apply and minimally invasive procedure [25,43].
The investigator (CK) will measure the intra-abdominal pressure via a sterile single-transducer pressure monitoring set, which will be attached to the patient's urinary catheter at one end and to a portable monitor capable of measuring pressure at the other end.
The measured value will be recorded in Excretory Activities Form.
|
up to first defecation an average of 3 days
|
|
Return time of bowel sounds
Time Frame: up to first defecation an average of 3 days
|
The return time of bowel sounds will be evaluated morning and evening and recorded in the Excretory Activities Form.
|
up to first defecation an average of 3 days
|
|
Number of bowel sounds
Time Frame: up to first defecation an average of 3 days
|
The number of bowel sounds will be evaluated morning and evening and recorded in the Excretory Activities Form.
|
up to first defecation an average of 3 days
|
|
First defecation time
Time Frame: up to first defecation an average of 3 days
|
The time to first defecation will be asked morning and evening after surgery and recorded in the Excretory Activities Form.
|
up to first defecation an average of 3 days
|
|
Amount of laxative use
Time Frame: up to first defecation an average of 3 days
|
The amount of drug use to assist with defecation will be evaluated morning and evening and recorded in the Excretory Activities Form.
|
up to first defecation an average of 3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pulmonary Function Tests- FVC
Time Frame: up to first defecation an average of 3 days
|
The FVC value obtained using the Respiratory Function Test device will be recorded in the Pulmonary Function Tests Form.
|
up to first defecation an average of 3 days
|
|
Pulmonary Function Tests- FEV-1
Time Frame: up to first defecation an average of 3 days
|
The FEV-1 value obtained using the Respiratory Function Test device will be recorded in the Pulmonary Function Tests Form.
|
up to first defecation an average of 3 days
|
|
Pulmonary Function Tests- FEV1/FVC
Time Frame: up to first defecation an average of 3 days
|
The FEV1/FVC value obtained using the Respiratory Function Test device will be recorded in the Pulmonary Function Tests Form.
|
up to first defecation an average of 3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Gülay Altun Uğraş, doctorate, Mersin University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 30, 2021
Primary Completion (Actual)
September 30, 2022
Study Completion (Actual)
September 30, 2022
Study Registration Dates
First Submitted
October 27, 2021
First Submitted That Met QC Criteria
November 16, 2021
First Posted (Actual)
November 19, 2021
Study Record Updates
Last Update Posted (Actual)
March 15, 2023
Last Update Submitted That Met QC Criteria
March 14, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MersinUCKANAT-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intraabdominal Pressure
-
China Medical University HospitalCompletedIntraabdominal PressureTaiwan
-
Marmara UniversityCompletedIntraabdominal Pressure | Bariatrik SurgeryTurkey
-
Azienda Ospedaliero, Universitaria PisanaRecruitingBiomarker | Infection, Intraabdominal | Sepsis AbdominalItaly
-
Carol Davila University of Medicine and PharmacyRecruiting
-
Marmara UniversityTerminatedIntraocular Pressure | Intracranial Pressure | Positive End-expiratory PressureTurkey
-
University of LeedsThe Leeds Teaching Hospitals NHS TrustCompletedComplicated Intraabdominal InfectionsUnited Kingdom
-
McMaster UniversityQueen's University; Kindera Living; Room 217 FoundationNot yet recruitingPressure Injury | Pressure Injuries | Pressure Ulcer (PU)Canada
-
King Abdullah Medical CityRecruitingPressure Injury | Pressure Ulcer, Buttock | Pressure Injury Stage 2 | Pressure Ulcers Stage II | BedsoreSaudi Arabia
-
Compremium AGRecruitingIntracranial Pressure | Intracranial Pressure ChangesUnited States
-
GE HealthcareRecruitingBlood Pressure Measurement | Blood PressureFinland
Clinical Trials on Abdominal massage
-
TC Erciyes UniversityCompletedAbdominal Pain | Satisfaction, Patient | DistentionTurkey
-
University of PotsdamNot yet recruitingDysmenorrhea | Dysmenorrhea Primary | Dysmenorrhea Secondary | Dysmenorrhea Symptom
-
Marmara UniversityIstanbul University - CerrahpasaRecruiting
-
University Hospital, Clermont-FerrandRecruitingDigestive System Disease | Preterm Birth ComplicationFrance
-
Air Force Military Medical University, ChinaRecruitingCommon Bile Duct Stone | Abdominal MassageChina
-
Firat TukenmezCompleted
-
Saglik Bilimleri UniversitesiCompletedGastrointestinal SymptomsTurkey (Türkiye)
-
Amasya UniversityCompleted
-
Bahçeşehir UniversityCompleted
-
University of Health Sciences LahoreCompleted