跳至主要内容
临床试验/NCT07117838
NCT07117838已完成不适用

Distractional Interventions on Patients' Anxiety, Pain and Physiological Parameters Durıng Coronary Angiography: The Effect of Virtual Reality and Music

HARUN ÜNAL1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年4月8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
发起方
入组人数
120
试验地点
1
主要终点
Patient Identification Form

研究概览

简要总结

"Coronary The scope of this study, which was conducted for the purpose of "Distracting Interventions on Patients' Anxiety, Pain and Physiological Parameters During Angiography: The Effect of Virtual Reality and Music", is to help patients at the level of evidence during coronary angiography and to contribute to the literature.

详细描述

Before starting the application, patients who meet the criteria for inclusion in the study will be determined according to the randomization order and information about the study will be given.

Patients will be randomly assigned to the control and intervention groups (virtual reality and music group). Then, the following interventions will be applied sequentially, depending on the group the patient is included in.

After the appropriate participants are determined, written informed consent will be given to the participants and the Patient Introduction Form, State Anxiety Scale and Visual Comparison Scale will be applied just before the procedure begins, and then the patient's physiological parameters will be measured and recorded in the Patient Monitoring Form. Later patients will undergo coronary angiography. For the control group, conventional procedures will be applied by the researcher and medical care staff.

Patients in the virtual reality group, one of the intervention groups, will be shown a video with predetermined relaxing visuals and sounds through virtual reality glasses. Before watching the video, the researcher informed about the use of virtual reality glasses.

The patient will be informed. They will use the SG glasses for 3-5 minutes before the procedure begins for the patient to get used to it, and then the procedure will begin. VR glasses will be kept on throughout the procedure. In addition, the patient is advised at any stage of the application.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Between the ages of 18-70, Patients who agreed to participate in the study voluntarily, Open to communication, Knows how to read and write, Patients without visual or auditory impairments, Patients who underwent femoral artery area intervention, Patients who are administered opioid and tranquilizer derivative drugs, Patients who were undergoing coronary angiography for the first time were included in the study.

排除标准

  • •Having difficulty using virtual reality glasses, Patients with headache, nausea and vomiting were not included in the study.

研究组 & 干预措施

virtual reality

Experimental

Patients were fitted with virtual reality glasses.

干预措施: virtual reality (Other)

music

Experimental

Patients were listened to music

干预措施: music (Other)

control

No Intervention

Patients were not interfered with and were receive standard care.

结局指标

主要结局

Patient Identification Form

时间窗: 10 minutes

This form, prepared by researchers based on literature reviews, consists of a total of 13 questions to question the socio-demographic characteristics of patients and their disease-related characteristics.

State Anxiety Scale

时间窗: 10 minutes

The study used the "State and Trait Anxiety Scale," developed by Spielberger et al. (1970) and translated and adapted into Turkish by Oner and Le Compte (1998). The scale consists of a total of 40 items and two separate scales. The first section includes the "State Anxiety Scale," which measures how a person feels in a given moment. The second section includes the "Trait Anxiety Scale," which also includes statements about how a person generally feels. This study was designed for use during coronary angiography, and the "State Anxiety Scale" was used based on literature research and expert opinions.

Patient Follow-up Form

时间窗: 10 minutes

This is a form created by researchers to record the physiological parameters (heart rate, respiratory rate, systolic blood pressure, diastolic blood pressure, oxygen saturation) measured by researchers before (manually), during (digitally via a femoral catheter), and after the procedure (digitally via a femoral catheter). The measurements taken from the patient were recorded on this form.

Visual Analog Scale

时间窗: 10 minutes

The VAS, whose validity and reliability study was conducted by Price et al. (1983), is a tool that subjectively assesses and measures people's pain experiences. The VAS is frequently used in assessing pain levels in adults and is considered the fastest and simplest to understand among single-dimensional scales. To determine pain intensity, the patient is asked to mark the score corresponding to the quantitative pain experienced on a 10-cm ruler, with the "0" point at one end representing "no pain" and the "10" point at the other end representing "the most severe pain." The scale can be applied horizontally or vertically. The point marked by the patient is used as numerical data to determine the level of pain perception. On this scale, a "0" point indicates no pain, while a "10" point describes the most severe pain.

次要结局

未报告次要终点

研究者

发起方
HARUN ÜNAL
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

HARUN ÜNAL

Investigator

Ataturk University

研究点 (1)

Loading locations...

相似试验