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Effect of Acupressure on Recovery of Bowel Function in Patients Post Cesarean Section

Primary Purpose

Acupressure, Post-Op Complication, Cesarean Section

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Acupressure
Sponsored by
Rajavithi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acupressure

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Pregnancy woman age 18-45 years
  2. General anesthesia
  3. Co-operate in research
  4. Can speak in thai language

Exclusion Criteria:

  1. Twin pregnancy
  2. Placenta previa
  3. Placental abruption
  4. Chorioamnionitis
  5. Complication intraoperation (Bowel or bladder injury)
  6. Post partum hemorrhage
  7. Abdominal adhesion
  8. Opertative time more than 2 hour
  9. History gastrointestinal surgery
  10. Prior acupressure
  11. Neurological disease
  12. Neuromuscular disease
  13. Hepatic disease

Sites / Locations

  • Rajavithi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acupressure

No acupressure

Arm Description

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

Standard post-operative care

Outcomes

Primary Outcome Measures

To study the duration of the first time to flatus passage in post cesaren section patient
the duration ; hour after post cesaren section

Secondary Outcome Measures

To study the duration of the first time to have bowel sound in post cesaren section patient
the duration ; hour after post cesaren section
To study the duration of the first time to pass stool in post cesaren section patient
the duration ; hour after post cesaren section
To study the symptomatic about Nausea/vomiting in post cesaren section patient
Score; mild,moderate,severe

Full Information

First Posted
October 26, 2020
Last Updated
September 10, 2021
Sponsor
Rajavithi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04620850
Brief Title
Effect of Acupressure on Recovery of Bowel Function in Patients Post Cesarean Section
Official Title
Effect of Acupressure on Recovery of Bowel Function in Patients Post Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 15, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajavithi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acupressure, Post-Op Complication, Cesarean Section, Bowel Ileus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupressure
Arm Type
Experimental
Arm Description
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
Arm Title
No acupressure
Arm Type
No Intervention
Arm Description
Standard post-operative care
Intervention Type
Device
Intervention Name(s)
Acupressure
Intervention Description
Acupressure after cesarean section 3 hr and then next 3 hr (duration 10 min per time)
Primary Outcome Measure Information:
Title
To study the duration of the first time to flatus passage in post cesaren section patient
Description
the duration ; hour after post cesaren section
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
To study the duration of the first time to have bowel sound in post cesaren section patient
Description
the duration ; hour after post cesaren section
Time Frame
through study completion, an average of 1 year
Title
To study the duration of the first time to pass stool in post cesaren section patient
Description
the duration ; hour after post cesaren section
Time Frame
through study completion, an average of 1 year
Title
To study the symptomatic about Nausea/vomiting in post cesaren section patient
Description
Score; mild,moderate,severe
Time Frame
mild

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sasiwimol kunnitikorn, MD
Organizational Affiliation
Rajavithi Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Rajavithi Hospital
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

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Effect of Acupressure on Recovery of Bowel Function in Patients Post Cesarean Section

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