Nonpharmacological Method for Relief of Episiotomy

NCT05649124 | Completed

• 1 other identifier: sdilek2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a randomized controlled study to evaluate the effectiveness of acupressure applied to primiparous pregnant women who underwent episiotomy in the early postpartum period. The research was carried out between August 2022 and November 2022 at Düzce University Health Practice and Research Center with mothers who gave vaginal birth. The research was carried out with two groups as acupressure and control groups. The sample number was calculated using the G\*Power 3.1.9.2 program and the acupressure group: 30 and the control group: 30. It was collected the research data with the Introductory Information Form and Visual Analog Scale. The participants in the acupressure group were interviewed at the 3rd and 5th hours after birth. The application announcement was made and they were allowed to sign the voluntary consent form. The VAS was filled by the participant before the application. Acupressure was applied to SP6, ST36 and LI4 points for a total of 12 minutes. After the application, the VAS was filled again by the participant. No application was made to the control group. The data of the research was evaluated using the Statistical Package 22.0 program for Social Sciences. In the evaluation of the data; descriptive statistics was given as percentage, arithmetic mean±standard deviation, median and minimum-maximum values. Independent two-sample t-test was used for normally distributed variables and Mann-Whitney U test was used for non-normally distributed variables. Pearson Correlation test was applied to determine the relationship between the pain intensity of the acupressure group and the tests and to determine the relationship between the tests. Statistical significance level was accepted as p\<0.05.

Conditions

Pain

Keywords

Episiotomy, acupressure, pain

Outcome Measures

Primary Outcomes (2)

• VAS (Visual analog scale) Evaluation of Perineal Pain

  The patient marks his or her own pain on a 10 cm ruler, which says no pain on one end and the most severe pain on the other end. The patient is told that there are two endpoints and to mark anywhere between these points that matches the severity of the pain. The distance between the onset of no pain and this point marked by the patient is measured and recorded in centimeters. It is stated that VAS is more sensitive and reliable than other unidimensional scales in pain severity measurement. The VAS is more sensitive than the simple descriptive scale.

  It was applied to evaluate perineal pain just before the application of acupressure at the 3rd hours postpartum.

• VAS (Visual analog scale) Evaluation of Perineal Pain

  The patient marks his or her own pain on a 10 cm ruler, which says no pain on one end and the most severe pain on the other end. The patient is told that there are two endpoints and to mark anywhere between these points that matches the severity of the pain. The distance between the onset of no pain and this point marked by the patient is measured and recorded in centimeters. It is stated that VAS is more sensitive and reliable than other unidimensional scales in pain severity measurement. The VAS is more sensitive than the simple descriptive scale.

  It was applied to evaluate perineal pain just before the application of acupressure at the 5th hours postpartum.

Secondary Outcomes (2)

• VAS (Visual analog scale) Evaluation of Perineal Pain

  It was applied to evaluate perineal pain immediately after acupressure application at the postpartum 3rd hour.

• VAS (Visual analog scale) Evaluation of Perineal Pain

  It was applied to evaluate perineal pain immediately after acupressure application at the postpartum 5th hour.

Study Arms (2)

Acupressure group

EXPERIMENTAL

* Participants in this group will be interviewed at postpartum 3rd and 5th hours. The application will be explained and a voluntary consent form will be signed. * Participant Information Form will be filled in by the researcher by face-to-face interview. * The VAS and McGill Pain Questionnaire, which will be applied to evaluate perineal pain at the 3rd and 5th hours of the postpartum period, will be filled in by the participant. * In a total application where SP6, ST36 and LI4 points will be applied for 2 minutes, the total time will be 12 minutes. * After the application, the VAS and McGill Pain Questionnaire Evaluating Perineal Pain will be filled in by the participant. * The participant will be informed that the study has been completed.

Behavioral: Acupressure group

Control group

NO INTERVENTION

* Participants in this group will be interviewed at postpartum 3rd and 5th hours. The application will be explained and a voluntary consent form will be signed. * Participant Information Form will be filled in by the researcher by face-to-face interview. * 3\. VAS (Visual analog scale) and McGill Pain Questionnaire for Evaluating Perineal Pain will be required at 5th and 5th hours. * No application will be made other than routine applications.

Interventions

Acupressure group BEHAVIORAL

A suitable environment will be prepared for mothers in terms of warmth and light, where privacy can be protected. The application points will be determined with the acu-point device by choosing the most comfortable position of the mother, leaving the application points open. The most preferred points LI4, SP6 and ST36 were selected among the points that were reported to be effective in relieving luterus pain by scanning the literature on the points to be compressed. Acupressure will be applied to the points (bidirectional, right and left) for 2 minutes, for a total of 8 minutes. Light pressure will be applied with the thumb of the practitioner's hand. Immediately after applying pressure for 2 minutes for each point, it is passed to the other point in the symmetrical region and the application is made without interruption. While practicing, the researcher will check the time using a digital wristwatch with a stopwatch.

Acupressure group

Eligibility Criteria

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

You may qualify if:

• Elementary school or higher education
• years and over,
• Primiparous,
• Episiotomy was applied,
• Having a normal delivery in the hospital where the study was conducted,
• Able to speak and understand Turkish,
• No medical treatment to affect the pain,
• Perineal pain score is above 4 according to VAS (Visual analog scale),
• Participants who voluntarily agree to participate in the study will be included in the study.

You may not qualify if:

• Does not have sufficient mental health to fill out the questionnaire,
• Experiencing postpartum complications (bleeding, infection, etc.),
• With impaired tissue integrity in the area to be applied,
• Having genital infection
• Heir in perineum,
• Taking painkillers in the last 6 hours,
• Smoking or using alcohol
• Pharmacological and non-pharmacological intervention to reduce postpartum perineal pain,
• Excluding episiotomy in a different region of the perineum, In addition, those who want to leave the research at any stage of the research will be excluded from the research.

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, 41380, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Sena Dilek Aksoy, Ph.D.

  Kocaeli University

  PRINCIPAL INVESTIGATOR

• Burcu Ozturk, M.Sc.

  Duzce Ataturk State Hospital

  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: Principal Investigator

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: December 13, 2022
• Study Start: December 13, 2022
• Primary Completion: March 13, 2023
• Study Completion: May 18, 2023
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)