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临床试验/NCT07545850
NCT07545850Enrolling By Invitation不适用

Determination of the Effect of Using Virtual Glasses on Pain and Anxiety During IUD Application

Inonu University1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2024年3月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
114
试验地点
1
主要终点
Visual Analog Scale (VAS)

研究概览

简要总结

This randomized controlled experimental study aimed to determine the effect of using virtual glasses during IUD application on pain and anxiety.

The hypotheses of the study were determined as follows. H1-a: Using virtual glasses during IUD application affects the level of pain. H1-b: Using virtual glasses during IUD application affects the level of anxiety.

详细描述

Data collection tools will be collected from women who applied IUD between March 2024-March 2025 at the Family Planning Clinic of Malatya Education and Research Hospital and who agreed to participate in the study, using the face-to-face interview method on weekdays by the researchers. Data will be collected in two stages. The application time of the data collection tools is planned to be completed in approximately 20 minutes as pre-test and post-test. Before the SG glasses are applied to the women in the experimental group, the Personal Information Form, State Anxiety Scale (SAS), and Visual Analog Scale (VAS) will be applied and pre-test data will be collected. Then, these women will watch videos with nature scenery while using SG glasses. After the IUD application process is completed, the State Anxiety Scale (SAS), Visual Analog Scale (VAS) and a survey containing questions about SG glasses will be applied to the women in the experimental group again and the post-test data will be collected and the data collection process will be completed. Pre-test data will be collected by applying the State Anxiety Scale (SAS) and Visual Analog Scale (VAS) to the women in the control group before the IUD application. No intervention will be applied to these women during the IUD application process. After the IUD application process is completed, the State Anxiety Scale (SAS) and Visual Analog Scale (VAS) will be applied to the women in the control group again, and the post-test data will be collected, and the data collection process will be completed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Literate,
  • No communication problems,
  • No psychiatric diagnosis,

排除标准

  • diagnosed with psychiatric disorders having vision problems wearing glasses

研究组 & 干预措施

standard care

No Intervention

The group that did not use virtual reality glasses

group that used virtual reality glasses

Experimental

The group that used virtual reality glasses

干预措施: virtual reality application (Other)

结局指标

主要结局

Visual Analog Scale (VAS)

时间窗: 20 minute

VAS is a scale created between 0-10 cm. According to the scale, 0 cm: pain is not severe at all, 10 cm: unbearable pain. On the scale, 0-44 mm indicates mild pain, 45-74 mm indicates moderate pain, and 75-100 mm indicates severe pain.

次要结局

  • Spielberger State Anxiety Inventory(20 minute)

研究者

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

Mevhibe Coban

PhD student

Inonu University

研究点 (1)

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