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临床试验/NCT05641467
NCT05641467已完成不适用

The Effect Of Watchıng Vıdeo Wıth Vırtual Realıty Glasses On Paın, Anxıety And Satısfactıon Durıng Epızıotomy Repaır

Selcuk University2 个研究点 分布在 2 个国家目标入组 82 人开始时间: 2022年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
2
主要终点
State-Trait Anxiety Inventory (STAI)-Questionnaire

研究概览

简要总结

H1-1: Watching video with virtual reality glasses during episiotomy repair reduces the level of pain.

H1-2 Watching video with virtual reality glasses during episiotomy repair reduces the level of anxiety.

H1-3: Watching video with virtual reality glasses during episiotomy repair increases the level of satisfaction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18 years and over,
  • Able to speak Turkish and express himself in Turkish,
  • There is no visual or hearing impairment,
  • Being open to communication, spiritually and mentally healthy,
  • 37- 42 weeks of gestation
  • Single pregnancy,
  • Primiparity,
  • Vaginal delivery,
  • Vertexpresentation
  • Media lateral episiotomy,
  • Uncomplicated newborn
  • Newborns between 2500 and 4000 g.
  • Those with episiotomy between 4-8 cm

排除标准

  • Presence of obstetric or non-obstetric complications,
  • Presence of bleeding requiring urgent measures,
  • Administration of sedative drugs before and during episiotomy repair, spinal anesthesia, epidural anesthesia, pudendal block (except for local infiltration of the perineum),
  • Lacerations other than episiotomy (anal sphincter injury or Grade 3 or 4 tear),
  • Instrument delivery (with vacuum or forceps),
  • Postpartum complications in newborns,
  • Chronic disease (diabetes mellitus, thyroid disease and hypertension),
  • Having a psychiatric diagnosis

结局指标

主要结局

State-Trait Anxiety Inventory (STAI)-Questionnaire

时间窗: immediately before repair episiotomy

State-Trait Anxiety Inventory (STAI)-Questionnaire \[ Time Frame: up to one hour \] STAI was used to measure the anxiety level of pregnant women. It was developed by Spielberger et al. (Spielberger et al., 1970) and Öner and Le Compte conducted a Turkish validity and reliability study of the scale (Öner \& LeCompte, 1983). In the scale, individuals are provided to express their feelings with 40 expressions. With the state anxiety scale, it is possible to determine how the individual feels at the moment and in the conditions, and with the trait anxiety scale, how he feels outside of the current situation and conditions. The scale is a 4-point Likert type.The last score obtained shows the anxiety level of the individual. High scores from the scale indicate an increased level of anxiety, low scores indicate a decrease.

Socio-Demographic Data Collection Form

时间窗: in active phase on labor (4 cm vaginal dilatation)

Pregnant Introductory Information Form is a questionnaire prepared by researchers using the literature.

Visual Analog Scale-Pain (VAS-P)

时间窗: immediately before repair episiotomy

The VAS-P, which is used to evaluate the severity of pain, is a 10 cm long horizontally or vertically drawn ruler, starting with "No pain (0)" and ending with "Unbearable pain (10)". The woman is asked to show the point on this line that corresponds to the intensity of pain she feels. The distance between the marked point and the starting end of the line (0=no pain) is measured in centimeters and the numerical value found shows the severity of the patient's pain (Hayes and Patterson 1921). VAS-P is accepted as a safe, valid and usable measurement tool in repeated measurements. In this study, horizontally prepared VAS-P was used to assess pain intensity.

次要结局

  • Satisfaction Evaluation Scale and Form(immediately after episiotomy repair)
  • Visual Analog Scale-Pain (VAS-P)(immediately after episiotomy repair)
  • Birth Action Follow-up Form(60 minutes after birth)
  • State-Trait Anxiety Inventory (STAI)-Questionnaire(immediately after episiotomy repair)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rüveyde CAN

Principal Investigator

Selcuk University

研究点 (2)

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