- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04620850
Effect of Acupressure on Recovery of Bowel Function in Patients Post Cesarean Section
September 10, 2021 updated by: Rajavithi Hospital
Research objectives To compare the efficacy of acupressure with no acupressure to examine time to first flatus in patient post cesarean section
; Acupressure at ST-36 Zusanli (lateral to anterior crest of tibia, in the tibialis anterior muscle)
Research hypothesis Patients who received acupressure will have earlier flatus passage
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Research design Randomized controlled trial.
Compare between The investigators is who assess the acupressure with control group is the participants do not assess the acupressure
Study Type
Interventional
Enrollment (Actual)
48
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
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-
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Bangkok, Thailand
- Rajavithi Hospital
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-
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
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Pregnancy woman age 18-45 years
- General anesthesia
- Co-operate in research
- Can speak in thai language
Exclusion Criteria:
- Twin pregnancy
- Placenta previa
- Placental abruption
- Chorioamnionitis
- Complication intraoperation (Bowel or bladder injury)
- Post partum hemorrhage
- Abdominal adhesion
- Opertative time more than 2 hour
- History gastrointestinal surgery
- Prior acupressure
- Neurological disease
- Neuromuscular disease
- Hepatic disease
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: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Acupressure
Acupressure after cesarean section 3 hr and then next 3 hr (duration 10 min per time) Acupressure at below knee the point ai locate about4 finger spcae below patella on the lateral side of tibia bone
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Acupressure after cesarean section 3 hr and then next 3 hr (duration 10 min per time)
|
|
NO_INTERVENTION: No acupressure
Standard post-operative care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To study the duration of the first time to flatus passage in post cesaren section patient
Time Frame: through study completion, an average of 1 year
|
the duration ; hour after post cesaren section
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through study completion, an average of 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To study the duration of the first time to have bowel sound in post cesaren section patient
Time Frame: through study completion, an average of 1 year
|
the duration ; hour after post cesaren section
|
through study completion, an average of 1 year
|
|
To study the duration of the first time to pass stool in post cesaren section patient
Time Frame: through study completion, an average of 1 year
|
the duration ; hour after post cesaren section
|
through study completion, an average of 1 year
|
|
To study the symptomatic about Nausea/vomiting in post cesaren section patient
Time Frame: mild
|
Score; mild,moderate,severe
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mild
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Sasiwimol kunnitikorn, MD, Rajavithi Hospital
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)
November 15, 2020
Primary Completion (ACTUAL)
June 30, 2021
Study Completion (ACTUAL)
July 30, 2021
Study Registration Dates
First Submitted
October 26, 2020
First Submitted That Met QC Criteria
November 6, 2020
First Posted (ACTUAL)
November 9, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 13, 2021
Last Update Submitted That Met QC Criteria
September 10, 2021
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 165/2563
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.
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