The Effect of Post-Cesarean Section Acupressure on the Severity of Pain and First Mobilization Distance

NCT05311449 | Completed DMC

• 1 other identifier: Mersin Universit
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial evaluates the effect of acupressure application on cesareans' pain and the number of steps in the first mobilization. This study hypothesizes that acupressure reduces pain and improves number of steps.

Conditions

Pain; Mobilization

Keywords

Post-cesarean; Acupressure; Pain; Step; Mobilization

Outcome Measures

Primary Outcomes (1)

• Pain evaluated using the visual analog scale

  The total scale score is in the range of 0 cm (minimum) -10 cm (maximum). A score of 0 indicates no pain and a score of 10 indicates very severe pain.

  Change from before implementation and after 1 minute, 2nd and 4th hour after implementation

Secondary Outcomes (1)

• The number of steps using step counter (TNV 3D Pedometer (Model: PM2000, Made in China)

  Change 4th hour after acupressure

Study Arms (2)

Acupressure Group (experimental)

EXPERIMENTAL

The experimental group will be given acupressure.

Other: Acupressure

Placebo Acupressure Group (control)

PLACEBO COMPARATOR

The placebo group will be given placebo acupressure.

Other: Plasebo acupressure

Interventions

Acupressure OTHER

The experimental group will start with LI4 points, and continue with P6 and SP6 points. The application will be carried out by determining the priority order of the points with the draw. Attention will be paid to the intensity and duration of the pressure deemed appropriate. Since the individuals' responses will differ, the stiffness and pressure will be adjusted according to the individual's sensitivity not to cause tissue damage. Before starting the application, around the area to be pressed for 20-30 seconds will be gently rubbed with palm. With the gentle rubbing of the surrounding tissue, the tension and tissue sensitivity in warming, relaxing and preparatory will be reduced, and the tissue will be relieved. After, the point determined will be pressed manually for 2 minutes.

Also known as: Acupress

Acupressure Group (experimental)

Plasebo acupressure OTHER

In the control group, the application will start with the points 1.5 cm around the LI4, P6 and SP6 points. The application process will continue in the same way with acupressure group and the pressure intensity will be less.

Also known as: Placebo Acupress

Placebo Acupressure Group (control)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being conscious,
• The mother tongue is Turkish,
• To be oriented and cooperative,
• be between 18-45 years old,
• To voluntarily agree to participate in the study (signing the Informed Consent Form),
• Repeated cesarean section,
• Cesarean section under spinal anesthesia,
• Not having a risky pregnancy (preeclampsia, gestational diabetes etc.),
• No health problems of the fetus,
• To have given birth by cesarean section between 37-40 weeks,
• To be in the second hour of the postpartum period,
• Not receiving post-op patient-controlled analgesia,
• Not to have smoked or used alcohol during pregnancy,
• No complications in the mother and/or newborn after cesarean section,
• No sensitivity in the area where acupressure will be applied,

You may not qualify if:

• Lack of consciousness,
• The mother tongue is not Turkish,
• Not oriented and cooperative,
• Not to be between the ages of 18-45,
• Refusal to voluntarily participate in the study (those who did not sign the Informed Consent Form),
• Normal birth or cesarean delivery under general anesthesia,
• Cesarean delivery due to the risk of deterioration of maternal or fetal health,
• Not having had a risky pregnancy (preeclampsia, gestational diabetes, etc.),
• Not giving birth outside 37-40 weeks and by cesarean section,
• Not in the second hour of the postpartum period,
• Receiving post-op patient-controlled analgesia,
• To have used cigarettes and alcohol during pregnancy,
• Sensitivity in the area where acupressure will be applied,
• Presence of any systemic or psychiatric diagnosis,
• Active COVID-19 infection.

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University

Mersin, Yenişehir, 33343, Turkey (Türkiye)

Location

Related Publications (3)

• Chen Y, Xiang XY, Chin KHR, Gao J, Wu J, Lao L, Chen H. Acupressure for labor pain management: a systematic review and meta-analysis of randomized controlled trials. Acupunct Med. 2021 Aug;39(4):243-252. doi: 10.1177/0964528420946044. Epub 2020 Aug 18.

  PMID: 32811182 BACKGROUND

• Smith CA, Collins CT, Levett KM, Armour M, Dahlen HG, Tan AL, Mesgarpour B. Acupuncture or acupressure for pain management during labour. Cochrane Database Syst Rev. 2020 Feb 7;2(2):CD009232. doi: 10.1002/14651858.CD009232.pub2.

  PMID: 32032444 RESULT

• Akgun M, Boz I. The effects of acupressure on post-cesarean pain and analgesic consumption: a randomized single-blinded placebo-controlled study. Int J Qual Health Care. 2020 Nov 16;32(9):609-617. doi: 10.1093/intqhc/mzaa107.

  PMID: 32877509 RESULT

MeSH Terms

Conditions

Pain

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Duygu VEFİKULUÇAY YILMAZ, Doctorate

  Mersin University

  STUDY DIRECTOR

• Aslıhan AKSU, master

  Mersin University

  PRINCIPAL INVESTIGATOR

• Filiz DEĞİRMENCİ, master

  Mersin University

  PRINCIPAL INVESTIGATOR

• Gülay ALTUN UĞRAŞ, doctorate

  Mersin University

  PRINCIPAL INVESTIGATOR

• Mürşide ÇEVİKOĞLU KILLI, doctorate

  Mersin City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: In the study, a researcher (T.Ç.Y.) will determine the acupressure and placebo points to be applied to women. However, the researcher (A.A.) who will apply acupressure and placebo acupressure be blinded without knowing whether these points are acupressure or placebo points. Participants will not know that they are in the acupressure or placebo group. Thus, the research will be carried out as a double-blind randomized controlled trial. When the research is completed, the data of the control and study groups (A or B) will be transferred to the computer environment by a researcher independent of the research, and the data will be analyzed by a statistician and the findings will be reported.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Prospective, parallel, two-arm, randomized controlled clinical trial, double blind

Study Record Dates

• First Submitted: March 27, 2022
• First Posted: April 5, 2022
• Study Start: June 26, 2022
• Primary Completion: June 26, 2022
• Study Completion: July 22, 2022
• Last Updated: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)