Nonpharmacological Method for Relief During Episiotomy Repair
NCT Number: NCT06484309
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain
Interventions: BEHAVIORAL: Reflexology Group
Sponsor: Kocaeli University
Sex: FEMALE
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-01
Completion Date: 2024-12-31
Locations: Kocaeli University, Kocaeli, 41380, Turkey

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.

Primary Outcome Measures: 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 Outcome Measures: McGill Pain Questionnaire to assess episiotomy pain, The McGill Pain Questionnaire consists of three parts. The first part contains 15 descriptive word groups containing the characteristics of pain. 11 of these evaluate the sensory dimension of pain, and 4 evaluate the perceptual dimension. These descriptive words were rated on an intensity scale from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = excessive). In the first part of the scale, a total of three pain scores are obtained: sensory pain score, perceptual pain score and total pain score. In the second part, there are five word groups ranging from "mild pain" to "unbearable pain" to determine the severity of pain. In the third part, pain intensity is evaluated using a visual comparison scale. An increase in the score indicates that the pain also increases., 20 minutes after episiotomy repair is completed