NCT05251818

Brief Summary

Enema application to pregnant women and prohibition of oral feeding before cesarean section, general anesthesia applied during cesarean section, pain in the post-cesarean period, limitation of movement, insufficient fluid intake, low-fiber diet, hospital environment and drugs such as narcotics cause constipation. In addition, one of the most common complications after abdominal surgeries is postoperative ileus. Many noninvasive applications help to overcome this problem. This study was planned as a randomized controlled trial to examine the effect of acupressure on bowel functions after cesarean section. The research will be carried out between July 2021 and July 2022 at the Samsun Training and Research Hospital Gynecology and Pediatrics Hospital affiliated to the Samsun Provincial Health Directorate. The research will be carried out with two groups as acupressure and control group. The sample number was calculated using the G\*Power 3.1.9.2 program and the acupressure group: 26 and the control group: 26. In order to increase the analysis power, the number of people for each group was taken as 30 (n=60). It is planned to collect the data with the Postpartum Information Form. After the women in the acupressure group come to the service, 2 applications will be made in the first postpartum hour and 3 hours after the first application, and no application will be made to the control group. Intestinal sounds will be monitored every hour until the first bowel sounds are heard, and the "Postpartum Registration Form" given to the woman will be received and recorded at the post-op 24th hour. The data of the research will be evaluated using the Statistical Package for the Social Sciences 22.0 program. In the evaluation of the data; descriptive statistics percentage, arithmetic mean±standard deviation, median and minimum-maximum values will be given. Student t test, ANOVA test will be used for those with normal distribution, Mann-Whitney U and Kruskal Wallis tests for those who are not. Type 1 error level will be taken as 0.05. Pearson Correlation test will be applied to determine the relationship between the intestinal functions of the experimental group and the tests. Statistical significance level will be accepted as p\<0.05

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2022

Completed
Last Updated

April 26, 2022

Status Verified

April 1, 2022

Enrollment Period

7 months

First QC Date

February 3, 2022

Last Update Submit

April 19, 2022

Conditions

Keywords

AcupressureBowel movemetCaaesarean sectioDefecationFlatulence.

Outcome Measures

Primary Outcomes (3)

  • First bowel sound

    Bowel sounds will be heard from the abdominal region of the woman with a stethoscope every hour.

    until the first bowel sound to 24 hours

  • Gas removal time

    Hourly follow-up until the first gas removal time is heard

    until the first gassing up to 24 hours

  • Time to defecate

    Questioning every 12 hours until the first stool output

    First defecation up to one week after cesarean section

Study Arms (2)

Acupressure grubu

ACTIVE COMPARATOR

The first thing after the operation is to apply the thumb tool for approximately seven minutes, with 15 seconds of preparation and 1.5 minutes of application at each point of the LI4 and TH6 acupuncture points (the equivalent of working each point).The second application will be repeated three hours after the first application, with the same procedure. By the researcher, hourly monitoring will be done until the bowel sounds of the puerperant are heard, and the puerperant will be followed up until the gas and defecation output. The gas and defecation time of the puerperants will be questioned every 12 hours, and the information will be obtained by making a phone call with those who are discharged without defecation.

Other: acupressure

Control Group

ACTIVE COMPARATOR

No application will be made to the control group.. From the first postoperative hour, the researcher will follow the bowel sounds every hour until the first bowel sounds of the patient are heard. Postpartum women will be followed until gas and defecation are released. The gas and defecation time of the puerperants will be questioned every 12 hours, and the information will be obtained by making a phone call with those who are discharged without defecation.

Other: Control

Interventions

A suitable environment will be prepared for postpartum women where privacy can be protected. Application points will be determined by choosing the most comfortable position of the mother. LI4 and TH were selected as the most preferred points among the points reported to be effective on intestinal functions by scanning the literature on the determined points. Acupressure will be applied to the LI4 and TH6 points for a total of 12 minutes in the first hour after the surgery. Light pressure will be applied with the thumb of the practitioner's hand. After applying pressure for 2 minutes for each point, it is passed to the other point in the symmetrical region and the application is done without interruption

Acupressure grubu
ControlOTHER

No application will be made to puerperant women in this group. Only hourly follow-up will be done until the first bowel sound is heard. In addition, defecation and gas extraction will be questioned every 12 hours.

Control Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 18-35,
  • Having a cesarean section with general anesthesia,
  • After the operation, non-narcotic and the same type of analgesic substance is applied to provide pain control,
  • Able to speak and understand Turkish,
  • Postpartum women with at least primary school graduates will be included in the study.

You may not qualify if:

  • Being obese (BMI≥30),
  • Opioid medication given in the post-op period,
  • Any disease related to the digestive system,
  • Having a history of abdominal surgery,
  • Chronic constipation or irregularity in defecation habits,
  • Having any chronic disease (such as diabetes, hypertension, heart failure),
  • Pregnancy complications (such as preeclampsia, gestational diabetes),
  • The baby is in the intensive care unit,
  • Having any physical problem that will prevent the application of acupressure to LI4 and TH 6 points,
  • Women who develop disorders or insufficiency related to fluid-electrolyte balance, acid-base balance and tissue perfusion during and after the operation will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun Training and Research Hospital Gynecology and Pediatrics Hospital

Samsun, 09010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Flatulence

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Yasemin Sökmen, Lectur

    Ondokuz Mayıs University

    PRINCIPAL INVESTIGATOR
  • Resmiye Kaya Odabaş, Ress. Ass.

    Kocaeli University University

    STUDY CHAIR
  • Ayten Taşpınar, Prof. Dr.

    Aydin Adnan Menderes University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

February 3, 2022

First Posted

February 23, 2022

Study Start

July 10, 2021

Primary Completion

January 29, 2022

Study Completion

March 9, 2022

Last Updated

April 26, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations