Intraabdominal PressureNCT05127577
Effect of Abdominal Massage on Excretory Activity and Pulmonary Function Tests in Patients After Surgery
A study testing Abdominal massage in people with Intraabdominal Pressure, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
This study is aimed to determine the effect of abdominal massage on excretory activity and pulmonary function tests (PFT) in patients undergoing PKP. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Intraabdominal Pressure
- What is being tested?
- Abdominal massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2021to 30 Sep 2022
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Intraabdominal Pressure
- Being tested
- Abdominal massage
- Keywords
- Abdominal massage, Pulmonary function tests, Partial hip replacement, Nursing care, Excretory activity, Defecation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal massageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal massage group | Experimental | 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. Receives: Other: Abdominal massage |
| Control group | No intervention | The control group will be received routine treatment and care in the unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-abdominal Pressure Value
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.
Measured: up to first defecation an average of 3 days
Return time of bowel sounds
The return time of bowel sounds will be evaluated morning and evening and recorded in the Excretory Activities Form.
Measured: up to first defecation an average of 3 days
Number of bowel sounds
The number of bowel sounds will be evaluated morning and evening and recorded in the Excretory Activities Form.
Measured: up to first defecation an average of 3 days
First defecation time
The time to first defecation will be asked morning and evening after surgery and recorded in the Excretory Activities Form.
Measured: up to first defecation an average of 3 days
Amount of laxative use
The amount of drug use to assist with defecation will be evaluated morning and evening and recorded in the Excretory Activities Form.
Measured: up to first defecation an average of 3 days
Secondary outcomes (3)
Pulmonary Function Tests- FVC
The FVC value obtained using the Respiratory Function Test device will be recorded in the Pulmonary Function Tests Form.
Measured: up to first defecation an average of 3 days
Pulmonary Function Tests- FEV-1
The FEV-1 value obtained using the Respiratory Function Test device will be recorded in the Pulmonary Function Tests Form.
Measured: up to first defecation an average of 3 days
Pulmonary Function Tests- FEV1/FVC
The FEV1/FVC value obtained using the Respiratory Function Test device will be recorded in the Pulmonary Function Tests Form.
Measured: up to first defecation an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start30 Dec 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraabdominal PressureStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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
- Prospective, parallel, two-arm, randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Canan KANAT, Mersin University
- Investigators
- Gülay Altun Uğraş, doctorate, Study director, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127577
- Sponsor's protocol ID
- MersinUCKANAT-01
- Status last verified
- Mar 2023
- First submitted
- 27 Oct 2021
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Abdominal Massage on Excretory Activity and Pulmonary Function Tests in Patients With Partial Hip Replacement
- ClinicalTrials.gov ID
- NCT05127577
- Acronym / sponsor ID
- MersinUCKANAT-01
- Conditions
- Intraabdominal Pressure
- Keywords
- Abdominal massage, Pulmonary function tests, Partial hip replacement, Nursing care, Excretory activity, Defecation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 19 Nov 2021 (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.
This study is aimed to determine the effect of abdominal massage on excretory activity and pulmonary function tests (PFT) in patients undergoing PKP.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, parallel, two-arm, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Abdominal massage group | Experimental | Other: Abdominal massageAbdominal 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. |
| Control group | No intervention | –The control group will be received routine treatment and care in the unit. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
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 massageAbdominal 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. | Other | Abdominal massage group |
Primary outcome
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.
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.
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.
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.
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.
3 secondary outcomes
Pulmonary Function Tests- FVC
Time frame: 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
Pulmonary Function Tests- FEV1/FVC
Time frame: up to first defecation an average of 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
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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, doctorate study director
Mersin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal massage in people with Intraabdominal Pressure, run by Mersin University at 1 site 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-abdominal Pressure Value (time frame: up to first defecation an average of 3 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2023.