Nonpharmacological Method for Relief During Episiotomy Repair

NCT06484309 | Completed

• 1 other identifier: sdilek9
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

The study was planned as a randomized controlled trial to evaluate the effect of reflexology on perceived perineal pain during episiotomy repair. The research will be carried out with participants who gave birth vaginally at Darıca Farabi Training and Research Hospital between July and December 2024. The research will be carried out with two groups: reflexology and control groups. Considering the sample size in the R pwrss (Statistical Power and Sample Size Calculation Tools) program, a type 1 (alpha) error of 0.05 and a power of 0.80, it was calculated that the study group should be at least 32 in the reflexology group and 32 in the control group. Considering the confounding variables, it was planned to recruit 25% more participants for each group, and therefore it was decided to recruit 40 participants per group. The participants included in the study will be divided into two groups by determining which group they will be included in from the website called "Random List", a random number generation program. Thus, each participant's number and group number will be determined and recorded. Research data will be collected using the Participant Information Form, VAS (Visual Analog Scale) and McGill Ağrı survey, which were created by the researcher within the framework of the literature on the subject. The data of the research will be evaluated using SPSS (IBM) 29.0 program. In evaluating the data; Descriptive statistics and comparative statistical analyzes will be used. Statistical significance level will be accepted as p\<0.05.

Conditions

Pain

Keywords

Episiotomy; Reflexology; vaginal birth

Outcome Measures

Primary Outcomes (4)

• Visual analog scale to assess episiotomy pain

  The participant marks his or her pain on a 10 cm ruler; On one end it says no pain, on the other end it says worst pain. The participant is told that there are two extreme points and to mark any place between these points that corresponds to the severity of the pain. The distance between the pain stop and the 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 measuring pain intensity. VAS is more sensitive than the simple descriptive scale.

  5 minutes before episiotomy repair

• Visual analog scale to assess episiotomy pain

  The participant marks his or her pain on a 10 cm ruler; On one end it says no pain, on the other end it says worst pain. The participant is told that there are two extreme points and to mark any place between these points that corresponds to the severity of the pain. The distance between the pain stop and the 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 measuring pain intensity. VAS is more sensitive than the simple descriptive scale.

  10 minutes after episiotomy repair begins

• Visual analog scale to assess episiotomy pain

  The participant marks his or her pain on a 10 cm ruler; On one end it says no pain, on the other end it says worst pain. The participant is told that there are two extreme points and to mark any place between these points that corresponds to the severity of the pain. The distance between the pain stop and the 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 measuring pain intensity. VAS is more sensitive than the simple descriptive scale.

  20 minutes after episiotomy repair begins

• Visual analog scale to assess episiotomy pain

  The participant marks his or her pain on a 10 cm ruler; On one end it says no pain, on the other end it says worst pain. The participant is told that there are two extreme points and to mark any place between these points that corresponds to the severity of the pain. The distance between the pain stop and the 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 measuring pain intensity. VAS is more sensitive than the simple descriptive scale.

  5 minutes after episiotomy repair is completed

Secondary Outcomes (1)

• McGill Pain Questionnaire to assess episiotomy pain

  20 minutes after episiotomy repair is completed

Study Arms (2)

Reflexology Group

EXPERIMENTAL

* Participants will sign an informed voluntary consent form during the active phase of labor, * Group assignment will be made, * Participant Information Form will be filled in, * The study will continue if episiotomy is performed at birth; If episiotomy is not performed at birth, it will not be included in the study. * Episiotomy repair will be performed by CG after anesthesia (5 ml lidocaine 2%) is applied in the 3rd stage of labor, * Reflexology application will be performed during episiotomy repair, * Evaluation with VAS will be performed before repair, during perineal repair (internal), during skin repair and immediately after the repair is completed, * The McGill Pain Questionnaire will be completed 20 minutes after episiotomy repair.

Behavioral: Reflexology Group

Control group

NO INTERVENTION

* Participants will sign an informed voluntary consent form during the active phase of labor, * Group assignment will be made, * Participant Information Form will be filled in, * The study will continue if episiotomy is performed at birth; If episiotomy is not performed at birth, it will not be included in the study. * Episiotomy repair will be performed by CG after anesthesia (5 ml lidocaine 2%) is applied in the 3rd stage of labor, * Evaluation with VAS will be performed before repair, during perineal repair (internal), during skin repair and immediately after the repair is completed, * The McGill Pain Questionnaire will be completed 20 minutes after episiotomy repair.

Interventions

Reflexology Group BEHAVIORAL

* In the 3rd stage of labor, local anesthesia (5 ml lidocaine 2%) will be applied and episiotomy repair will begin. * Reflexology application will be started at the same time, * Reflexology application will continue for at least 20-30 minutes during the episiotomy repair until the episiotomy repair is completed, * Pain will be evaluated with VAS to determine the pain level four times in total: just before suturing, during perineal suturing (internal), during skin suturing and immediately after suturing is completed, * Approximately 15-20 minutes after the end of the episiotomy repair, a face-to-face interview will be held and the McGill Pain Questionnaire will be filled out.

Reflexology Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to read and write,
• Those who have sufficient mental health to fill out the survey form,
• Between the ages of 18-35,
• Primiparous,
• At term gestational age (37-42 weeks),
• Having spontaneous birth with medial lateral episiotomy,
• The baby is healthy (does not require intervention or treatment),
• Participants who volunteered to participate in the study.

You may not qualify if:

• Those with visual, hearing or perception impairments,
• Having obstetric complications,
• Those who are allergic to anesthetic drugs and latex,
• Those with vaginal anomalies and signs of infection,
• Those with lacerations other than episiotomy (anal sphincter injury or 3rd or 4th degree laceration),
• Having an episiotomy smaller than 2 cm and larger than 4 cm,
• If the newborn is unhealthy or stillborn,
• Having a newborn who needs oxygen support,
• Possible bleeding or bleeding,
• Participants requiring large amounts of anesthesia during episiotomy repair.

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (2)

Darica Farabi Training and Research Hospital

Kocaeli, 41000, Turkey (Türkiye)

Location

Kocaeli University

Kocaeli, 41380, Turkey (Türkiye)

Location

Related Publications (1)

• Sharifi N, Bahri N, Hadizadeh-Talasaz F, Azizi H, Nezami H, Tohidinik HR. A randomized clinical trial on the effect of foot reflexology performed in the fourth stage of labor on uterine afterpain. BMC Pregnancy Childbirth. 2022 Jan 21;22(1):57. doi: 10.1186/s12884-022-04376-w.

  PMID: 35062899 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Cemile Gokce, Midwife

  Darica Farabi Training and Research 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: June 20, 2024
• First Posted: July 3, 2024
• Study Start: July 1, 2024
• Primary Completion: October 23, 2025
• Study Completion: December 30, 2025
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)