跳至主要内容
临床试验/NCT06634615
NCT06634615招募中不适用

The Effect of Patient Education and in the Operating Room Family Interview Practices on Patient Outcomes Using Virtual Reality in Cholecystectomy Patients: A Randomized Controlled Trial

Marmara University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Stress

研究概览

简要总结

This study was planned to be a randomized controlled experimental study to determine the effect of patient education and family interview practices using virtual reality on stress intensity, anxiety and information need levels, sleep quality and satisfaction with the preparation process for surgery in cholecystectomy patients. The main questions it aims to answer are:

  • Is there a significant difference in stress intensity, anxiety, and information need levels between patients who received and did not receive patient education with VR glasses in the ward before cholecystectomy surgery?
  • Is there a significant difference in stress intensity and anxiety levels between patients who received and did not receive video family interviews with VR glasses in the operative waiting area before cholecystectomy surgery?
  • Is there a significant difference in stress intensity, anxiety, and sleep quality levels at discharge of groups that received different VR interventions?
  • What is the postoperative sleep quality of patients with low preoperative anxiety levels?
  • What is the satisfaction of patients who received VR with the surgery preparation process? The patients participating in the study will be numbered according to the order of hospitalization and assigned to one of the control, education, education+interview groups in accordance with the randomization list. Face-to-face communication will be established with each patient in the ward on the day of hospitalization, in the preoperative waiting area when they come to the operating room and in the ward on the day of discharge. Depending on the groups in which the patients are included, they will be shown an educational video using virtual reality goggles and/or will be allowed to meet with their families. No application will be made to the control group and the ward routine will continue.

详细描述

Virtual reality (VR) is an interactive field that offers sensory experiences such as three-dimensional vision, touch and hearing, allowing people to dive into the virtual world and feel that they are in a different environment. In healthcare services, it is seen that the effect of virtual reality technology on various patient outcomes has been examined by watching nature videos, training, exercise applications, museum tours with music and games. This study was planned to be a randomized controlled experimental study to determine the effect of patient education and family interview practices using virtual reality on stress intensity, anxiety and information need levels, sleep quality and satisfaction with the preparation process for surgery in cholecystectomy patients. G*Power (v3.1.9.7) program was used to determine the sample size in the study and considering possible losses, it was decided to include a total of 60 patients, 20 in each group.

During the data collection process, it is planned to include a total of six patients in the preliminary pilot application, two from the education group, two from the education+interview group, and two from the control group, for the comprehensibility and usability of the forms. Patients who have undergone preliminary application will not be included in the study. The patients participating in the study will be numbered according to the order of hospitalization and assigned to one of the control, education, education+interview groups in accordance with the randomization list. Face-to-face communication will be established with each patient in the ward on the day of hospitalization, in the preoperative waiting area when they come to the operating room and in the ward on the day of discharge. The first interview with the patients will be held in the patient room in the ward. During this interview, the patients will be invited to the study and the research will be explained. Informed voluntary consent will be obtained from the patients who agree to participate in the study. Depending on the groups in which the patients are included, they will be shown an educational video using virtual reality goggles and/or will be allowed to meet with their families. Data will be collected with the Introductory Information Form, Visual Analog Scale for Stress, Amsterdam Preoperative Anxiety and Information Scale (APAIS), Richards Campbell Sleep Scale (RCBS), Virtual Reality Evaluation Form and Visual Analog Scale for Satisfaction. Oculus Quest 2 VR glasses will be used as a virtual reality application tool in the study.

The virtual family meeting will be initiated through the meeting link shared with the patients relative, and VR glasses and computer connection will be provided with the BigScreen computer application. Patients have a video call with their family in a 360° designed home environment. The conversations are easily transmitted thanks to the internal speaker and microphone in the VR glasses. In order to adjust the patients viewing angle, to provide guidance when needed, and to monitor communication, the image the patient sees in the VR glasses will be monitored with the Meta Quest program installed on the researchers mobile phone. The training video is a 2-3 minute animated video with visual and auditory elements and includes the ward nurse coming to the newly admitted patient in a patient room and giving information. In order to prevent infection, after each patients use, the supporting pads, straps, and lenses of the virtual reality glasses will be disinfected with cleaner and allowed to dry. It will be kept in its own box and offered to the other patients use.

In the first phase of the study with the patients in the control group, the data collection tools including the Introductory Information Form, the Visual Analog Scale for Stress, the Amsterdam Preoperative Anxiety and Information Scale (APAIS) and the Richard-Campbell Sleep Scale (RCS) will be filled in on the day of admission. No intervention will be applied to the patients and routine procedures will continue. After 30 minutes, the patient will be asked to fill in the Visual Analog Scale for Stress and the Amsterdam Preoperative Anxiety and Information Scale (APAIS) again. In the second phase of the study, when the patients are taken to the preoperative waiting area of the operating room, the data collection tools including the Visual Analog Scale for Stress and the Amsterdam Preoperative Anxiety and Information Scale (APAIS) will be filled in. At the end of the period in which the patient waits to be taken to the operation, the patient will be asked to fill in the Visual Analog Scale for Stress and the Amsterdam Preoperative Anxiety and Information Scale (APAIS) again. In the final phase of the study, the Stress visual analog scale, Amsterdam preoperative anxiety and information scale (APAIS), Richard-Campbell sleep scale (RCUS) and Satisfaction visual analog scale will be filled in the patient room before discharge on the morning of the first postoperative day.

In the first phase of the study, the patients in the patient education group will first fill out the data collection tools including the Introductory Information Form, Stress visual analog scale, Amsterdam preoperative anxiety and information scale (APAIS) and Richard-Campbell sleep scale (RCUS) on the day of admission. Then, a patient education video about laparoscopic cholecystectomy operation will be watched with virtual reality glasses. 30 minutes after watching the education video, patients will be asked to fill out the Stress visual analog scale and Amsterdam preoperative anxiety and information scale (APAIS) again. In the second phase of the study, when the patients are taken to the preoperative waiting area of the operating room, the Stress visual analog scale and Amsterdam preoperative anxiety and information scale (APAIS) will be filled in the data collection tools including the Stress visual analog scale and Amsterdam preoperative anxiety and information scale (APAIS). At the end of the waiting period for the patient to be taken to the operation, they will be asked to fill out the Stress Visual Analog Scale and Amsterdam Preoperative Anxiety and Information Scale (APAIS) again. In the last stage of the study, on the morning of the first post-operative day, before discharge, the patient will be asked to fill out the data collection forms including the Stress Visual Analog Scale, Amsterdam Preoperative Anxiety and Information Scale (APAIS), Richard-Campbell Sleep Scale (RCUS), Virtual Reality Evaluation Form and Satisfaction Visual Analog Scale in the patient room.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Patients who volunteered to participate in the study,
  • who were 18 years of age or older,
  • who would undergo elective laparoscopic cholecystectomy surgery,
  • who had no vision, hearing and communication problems,
  • whose relatives had a smartphone and internet connection,
  • whose stress intensity was higher than 3 points (between 1-10 points) met the inclusion criteria.

排除标准

  • Patients with complaints of dizziness,
  • psychiatric disorders,
  • persistent sleep problems were excluded from the study.
  • Patients who voluntarily left the study,
  • interrupted the family video call with VR,
  • felt discomfort during VR application,
  • developed any allergy to the goggle material,
  • filled out the data collection forms incompletely and/or incorrectly will be excluded from the study.

结局指标

主要结局

Stress

时间窗: On the day of hospitalization, during the first interview with the researcher and 30 minutes later; When arriving in the operating room waiting area and before going to the operation; On the morning of the first post-operative day, before discharge.

It is an 11-step scale ranging from 0-I am not stressed at all, to 10-I am very stressed, on a 10 cm ruler to assess the stress intensity of patients. The ruler shows that the stress level increases as it goes from 0 to 10.

Anxiety and need for information

时间窗: On the day of hospitalization, during the first interview with the researcher and 30 minutes later; When arriving in the operating room waiting area and before going to the operation; On the morning of the first post-operative day, before discharge.

Total scale score is min. 6 and max. 30. High scores are associated with high anxiety levels and desire for information.

Sleep

时间窗: On the day of hospitalization, during the first interview with the researcher and on the morning of the first postoperative day before discharge.

Each item of the scale is evaluated and answered on a chart ranging from 0 to 100. A score between "0-25" from the scale indicates very poor sleep, and a score between "76-100" indicates very good sleep.

Satisfaction with the preparation process for surgery

时间窗: Post-op 1st day morning before discharge.

It is an 11-step scale ranging from 0-Not satisfied at all, 10-Very satisfied on a 10 cm ruler. The ruler shows that the level of satisfaction increases as it goes from 0 to 10.

次要结局

未报告次要终点

研究者

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

Çağla Islattı Mutlu

Research Assistant, Nurse

Marmara University

研究点 (1)

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