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临床试验/NCT07258420
NCT07258420已完成不适用

The Effect of Using Virtual Reality Glasses on Patients' Anxiety and Comfort Levels in Open Inguinal Hernia Surgery Performed With Spinal Anesthesia

Trakya University1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2023年9月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
1
主要终点
anxiety level

研究概览

简要总结

This study was conducted to evaluate the effect of using virtual reality glasses during surgery on patients' anxiety and comfort levels. The main hypotheses are as follows:

H1: 'During open inguinal hernia surgery performed with spinal anesthesia, anxiety levels of patients using virtual reality glasses are lower than those of patients who do not use them.' H2: It was determined that 'The comfort levels of patients who use virtual reality glasses during open inguinal hernia surgery performed with spinal anesthesia are higher than those of patients who do not use them'.

Participants will be asked to watch a video using VR goggles during surgery. If there is a comparison group: Researchers will compare patients to a control group to see if there are any differences in anxiety and comfort levels.

详细描述

Randomization method will be used to determine the groups. Randomization of the patients was done using 'Random Allocation Software 2.0' program and they were divided into 2 groups: 1) Control group and 2) Intervention group.

  1. Control Group: Patients in this group will be visited by the researcher in the pre-anesthesia listening room in the operating room before surgery. No other intervention will be made to the patients during surgery. Patients will be visited again in the post-anesthesia recovery room after surgery. Visual Analog Scale-A was used to assess the anxiety levels of the patients; Perioperative Comfort Scale was used to assess their comfort levels.
  2. Intervention Group: Patients in this group will be visited by the researcher in the pre-anesthesia recovery room in the operating room before surgery. Patients will be informed about the virtual reality glasses they will use during surgery. Patients will be asked to watch videos with virtual reality glasses during surgery. Patients will be visited again in the post-anesthesia recovery room after surgery. Visual Analog Scale-A was used to assess patients' anxiety levels; Perioperative Comfort Scale was used to assess their comfort levels.

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 (Outcomes Assessor)

盲法说明

The data analyse is going to be completed by a independent researcher.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •To research;
  • •Planned elective surgery
  • •Those who will undergo inguinal hernia surgery for the first time
  • •Those who do not have vision, hearing and perception problems
  • •Patients who want to participate in the study voluntarily were included.

排除标准

  • •Any anesthesia method other than spinal anesthesia was applied during the procedure
  • •Under the age of 18, over the age of 75
  • •Having advanced vision and hearing problems
  • •Diagnosed with mental and psychological illness
  • •Using anti-depressant/sedative medication
  • •Having stopped watching videos during the surgical procedure

研究组 & 干预措施

Intervention group

Experimental

Patients will be visited in the rest room in the operating room before the surgery and will be informed about the virtual reality glasses they will use during the surgery. Patients will be asked to watch videos with virtual reality glasses during the surgery. Visual Analog Scale-A was used to assess the anxiety levels of patients and Perioperative Comfort Scale was used to assess their comfort levels

干预措施: Using a virtual reality glasses (Other)

Control group

No Intervention

Patients in this group will be visited by the researcher in the pre-anesthesia listening room in the operating room before surgery. No other intervention will be made to the patients during surgery. Patients will be visited again in the post-anesthesia recovery room after surgery. Visual Analog Scale-A was used to assess the anxiety levels of the patients; Perioperative Comfort Scale was used to assess their comfort levels.

结局指标

主要结局

anxiety level

时间窗: 18 mounth

The anxiety levels of the patients will be evaluated with the Visual Analog Scale. It is a measurement tool that can be repeated and requires minimal tools, and is a one-dimensional scale frequently used in the measurement of subjective parameters. VAS is used to convert some values that cannot be measured numerically into numerical values. A 100 mm line is scaled with 10 mm intervals, the two end definitions of the parameter to be evaluated are written on both ends of the line, and the patient is asked to indicate where his/her own situation fits on this line by drawing, putting a dot, or pointing. To evaluate anxiety; "I have no anxiety" labels are placed on the zero point on the line divided into 10 cm, and "I feel a lot of anxiety" labels are placed above the 10th cm.

次要结局

  • comfort level(18 mounth)

研究者

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

Seher Ünver

Assos Prof

Trakya University

研究点 (1)

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