跳至主要内容
临床试验/NCT06680141
NCT06680141招募中不适用

The Effect of Virtual Reality Glasses Used Before Cesarean Section on Surgical Fear and Anxiety

Ondokuz Mayıs University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
2
主要终点
Spielberger State Anxiety Scale

研究概览

简要总结

The aim of this study is to determine the effect of Virtual Reality Glasses Used Before Cesarean Section on Surgical Fear and Anxiety

详细描述

Hypotheses 01; there was no difference between the Surgical Fear and Anxiety score of the Virtual Reality Glasses group and the control group.

The study will be carried out in two different groups. The practice will start with meeting the women whom will go to cesarean section in the hospital. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.

Virtual Reality Glasses Group; the intervention will be given glasses before the surgery and will be shown a video (30 minutes) of the 9-month fetal development process. Among the women who were admitted for a planned caesarean section, those who met the criteria would first be given the Informed Consent Form and a data collection form including sociodemographic characteristics, surgical fear scale, Spielberg State-Trait Anxiety Scale, and then randomization would be applied.

control group; the first surgical fear scale, anxiety scores will be recorded. After cesarean section anxiety scores will be recorded.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Will undergo a cesarean section for the first time,
  • Are over the age of 18,
  • Have no diagnosed mental illness,
  • Have no diagnosed physical illness in themselves or their baby,
  • Volunteer to participate in the study

排除标准

  • Have previously undergone a cesarean section,
  • Are under the age of 18,
  • Have a diagnosed mental illness,
  • Have a diagnosed physical illness in themselves or their baby, Do not volunteer to participate in the study. -

结局指标

主要结局

Spielberger State Anxiety Scale

时间窗: 30 minutes

The inventory was developed by Spielberger, Gorsuch, and Lushene in 1970. An adaptation, validity, and reliability study of the State-Trait Anxiety Scale in Turkish was conducted by Oner and Le Compte in 1983. The scale consists of two subdimensions: the state anxiety has 20 items and is used to determine what is felt at a specific moment under certain conditions, and the trait anxiety has 20 items and is used to determine what has been felt in the last 7 days. High scores from each subscale indicate a high level of anxiety. The Cronbach's a for the STAI ranges from 0.83 to 0.87. It will be applied half an hour before the surgery.

Surgical Fear Scale (SFS):

时间窗: 30 minutes

The scale was developed by Theunissen et al. (2014) and its validity and reliability for use in Turkey were established by Bağdigen and Karaman Özlü (2018). The scale consists of 8 items in an 11-point Likert format, scored between 0 and 10. It is divided into two subscales, each containing 4 items, measuring short-term and long-term fears related to surgery. Items 1-4 assess fear regarding short-term outcomes of surgery, while items 5-8 evaluate fear concerning long-term outcomes. Each item is rated from "0: not afraid at all" to "10: extremely afraid." A higher total score, with a maximum of 26 points, indicates a greater level of fear. In the validity and reliability study, the Cronbach's alpha coefficient for the total score was found to be 0.93.It will be applied half an hour before the surgery.

次要结局

未报告次要终点

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sümeyye BAL

Director

Ondokuz Mayıs University

研究点 (2)

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