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Nonpharmacological Method for Relief During Episiotomy Repair

NCT06484309 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-02-11

No results posted yet for this study

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

Interventions

BEHAVIORAL

Reflexology Group

* 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.

Sponsors & Collaborators

  • Kocaeli University

    lead OTHER

Principal Investigators

  • Cemile Gokce, Midwife · Darica Farabi Training and Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-10-23
Completion
2025-12-30

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06484309 on ClinicalTrials.gov