AcupressureNCT04620850
Effect of Acupressure on Recovery of Bowel Function in Patients Post Cesarean Section
A study testing Acupressure in people with Acupressure and Post-Op Complication, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acupressure, Post-Op Complication, Cesarean Section
- What is being tested?
- Acupressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteThailand
- Study dates
- 15 Nov 2020to 30 Jul 2021
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnancy woman age 18-45 years
- General anesthesia
- Co-operate in research
- Can speak in thai language
Who cannot join
- Twin pregnancy
- Placenta previa
- Placental abruption
- Chorioamnionitis
- Complication intraoperation (Bowel or bladder injury)
- Post partum hemorrhage
Show all 13Show fewer
- Abdominal adhesion
- Opertative time more than 2 hour
- History gastrointestinal surgery
- Prior acupressure
- Neurological disease
- Neuromuscular disease
- Hepatic disease
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Conditions
- Acupressure, Post-Op Complication, Cesarean Section, Bowel Ileus
- Being tested
- Acupressure
- Medical subject headings
- Postoperative Complications, Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureDevice
Acupressure after cesarean section 3 hr and then next 3 hr (duration 10 min per time)
| Study group | Role | What they receive |
|---|---|---|
| Acupressure | Experimental | 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 Receives: Device: Acupressure |
| No acupressure | No intervention | Standard post-operative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the duration of the first time to flatus passage in post cesaren section patient
the duration ; hour after post cesaren section
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
To study the duration of the first time to have bowel sound in post cesaren section patient
the duration ; hour after post cesaren section
Measured: through study completion, an average of 1 year
To study the duration of the first time to pass stool in post cesaren section patient
the duration ; hour after post cesaren section
Measured: through study completion, an average of 1 year
To study the symptomatic about Nausea/vomiting in post cesaren section patient
Score; mild,moderate,severe
Measured: mild
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start15 Nov 2020
- Primary completion30 Jun 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcupressureStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sasiwimol kunnitikorn, MD, Study chair, Department of Medical Services Ministry of Public Health of Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620850
- Sponsor's protocol ID
- 165/2563
- Status last verified
- Sep 2020
- First submitted
- 26 Oct 2020
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupressure on Recovery of Bowel Function in Patients Post Cesarean Section
- ClinicalTrials.gov ID
- NCT04620850
- Acronym / sponsor ID
- 165/2563
- Conditions
- Acupressure, Post-Op Complication, Cesarean Section, Bowel Ileus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 9 Nov 2020 (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.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupressure | Experimental | Device: AcupressureAcupressure 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 |
| No acupressure | No intervention | –Standard post-operative care |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnancy woman age 18-45 years
- General anesthesia
- Co-operate in research
- Can speak in thai language
Key exclusion criteria (13 listed)
- Twin pregnancy
- Placenta previa
- Placental abruption
- Chorioamnionitis
- Complication intraoperation (Bowel or bladder injury)
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 |
|---|---|---|
| AcupressureAcupressure after cesarean section 3 hr and then next 3 hr (duration 10 min per time) | Device | Acupressure |
Primary outcome
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
3 secondary outcomes
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
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
To study the symptomatic about Nausea/vomiting in post cesaren section patient
Time frame: mild
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 13 Sep 2021.
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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.
Sasiwimol kunnitikorn, MD study chair
Department of Medical Services Ministry of Public Health of Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure in people with Acupressure and Post-Op Complication, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
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 4 inclusion and 13 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 13 Sep 2021. 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 Thailand. 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?
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). 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 13 Sep 2021.