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

NCT ID: NCT05311449

Last Updated: 2022-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-26
• Study Completion Date: 2022-07-22

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.

Detailed Description

Methods: In the study, 64 cesareans will randomly assigned to acupressure and placebo acupressure groups. To the acupressure group (n = 32), an average of 15 minutes will be applied to the LI4 (liver), P6 (pericardium) and the Sanyinjia points on the splenic meridian (SP6) located on the inner side of the lower leg, four fingers above the ankle and behind the tibia. In the placebo acupressure group (n = 32), the points 1.5 cm away from the LI4, P6 and SP6 points (four points in total) will be applied for an average of 15 minutes. The primary outcome of the research is the effect of acupressure on the pain of cesareans. The secondary outcome of the study is to determine the effect of acupressure on the number of steps. The pain will be collected before and 1 minute, 2nd and 4th hour after acupressure and placebo acupressure administration. The number of steps will be collected 4th hour after acupressure and placebo acupressure administration.

Conditions

Pain; Mobilization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Acupressure Group (experimental)

The experimental group will be given acupressure.

Group Type: EXPERIMENTAL

Acupressure

Intervention Type: 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.

Placebo Acupressure Group (control)

The placebo group will be given placebo acupressure.

Group Type: PLACEBO_COMPARATOR

Plasebo acupressure

Intervention Type: 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.

Interventions

Acupressure

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.

Intervention Type: OTHER

Plasebo acupressure

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.

Intervention Type: OTHER

Other Intervention Names

Acupress; Placebo Acupress

Eligibility Criteria

Inclusion Criteria

• 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,
• Absence of any systemic or psychiatric diagnosis,
• Absence of active COVID-19 infection.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mersin University

OTHER

Sponsor Role: lead

Responsible Party

Tugba CAM YANIK

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Duygu VEFİKULUÇAY YILMAZ, Doctorate

Role: STUDY_DIRECTOR

Mersin University

Aslıhan AKSU, master

Role: PRINCIPAL_INVESTIGATOR

Mersin University

Filiz DEĞİRMENCİ, master

Role: PRINCIPAL_INVESTIGATOR

Mersin University

Gülay ALTUN UĞRAŞ, doctorate

Role: PRINCIPAL_INVESTIGATOR

Mersin University

Mürşide ÇEVİKOĞLU KILLI, doctorate

Role: PRINCIPAL_INVESTIGATOR

Mersin City Hospital

Locations

Mersin University

Mersin, Yenişehir, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 32811182 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32032444 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32877509 (View on PubMed)

Other Identifiers

Mersin Universit

Identifier Type: -

Identifier Source: org_study_id