The Effect of Reflexology on Perceived Perineal Pain During Episiotomy Repair.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Visual analog scale to assess episiotomy pain
研究概览
简要总结
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.
详细描述
Aim: To examine the effect of reflexology on perceived perineal pain during episiotomy repair.
Hypothesis(s):
H0: There is no difference between the perineal pain of the group in which reflexology was applied and the group in which reflexology was not applied during episiotomy repair.
H1: There is a difference between the perineal pain of the group in which reflexology was applied and the group in which reflexology was not applied during episiotomy repair.
Type of Research: This study was designed as a randomized controlled experimental study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Reflexology Group
- 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.
干预措施: Reflexology Group (Behavioral)
Control group
- 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.
结局指标
主要结局
Visual analog scale to assess episiotomy pain
时间窗: 5 minutes after episiotomy repair is completed
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.
Visual analog scale to assess episiotomy pain
时间窗: 5 minutes before episiotomy repair
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.
Visual analog scale to assess episiotomy pain
时间窗: 10 minutes after episiotomy repair begins
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.
Visual analog scale to assess episiotomy pain
时间窗: 20 minutes after episiotomy repair begins
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.
次要结局
- McGill Pain Questionnaire to assess episiotomy pain(20 minutes after episiotomy repair is completed)
研究者
Sena Dilek Aksoy
Principal Investigator
Kocaeli University