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临床试验/NCT05587946
NCT05587946Enrolling By Invitation不适用

The Effect of Virtual Reality Application Used During Endoscopy on Pain, Anxiety and Vital Signs: A Mixed Methods Study

İBRAHİM NAS1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
80
试验地点
1
主要终点
Oxygen saturation (SpO2) before the endoscopy procedure

研究概览

简要总结

In this study, the effect of virtual reality application used during upper gastrointestinal endoscopy on pain, anxiety and vital signs will be investigated. The research will be conducted as a mixed methods research including quantitative and qualitative methods. The exploratory sequence mixed design model, one of the mixed method designs, will be used in the research.

详细描述

Objective

In this study, the effect of virtual reality application used during upper gastrointestinal endoscopy on pain, anxiety and vital signs will be investigated. The research will be conducted as a mixed methods research including quantitative and qualitative methods. The exploratory sequence mixed design model, one of the mixed method designs, will be used in the research.

The research was carried out in the endoscopy unit of a university hospital in Van between November 2022 and March 2023. This research, in which an exploratory sequential mixed design was used, consists of two stages. In the research, the quantitative phase, in which a pretest-posttest design, randomized controlled, experimental method was used, was completed with 75 patients, and the qualitative phase, in which the phenomenological/phenomenological design was used, was completed with 19 patients. Patient introduction form, state anxiety scale, pain visual comparison scale, patient follow-up form and semi-structured interview form were used to collect data. IBM SPSS V23 program (quantitative) and inductive qualitative content analysis (qualitative) were used to analyze the data.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Exclusion criteria from quantitative section research;
  • sedation applied,
  • who want to withdraw from the study,
  • Patients using analgesics or anti-anxiety medications before and during the procedure
  • Exclusion criteria from qualitative departmental research;
  • Those in the control group

结局指标

主要结局

Oxygen saturation (SpO2) before the endoscopy procedure

时间窗: Just before the endoscopy procedure

Normal oxygen saturation usually ranges from 95% to 100%.

Oxygen saturation (SpO2) after endoscopy procedure

时间窗: within first 5 minutes after endoscopy procedure

Normal oxygen saturation usually ranges from 95% to 100%.

Blood pressure before the endoscopy procedure

时间窗: Just before the endoscopy procedure

90/60 mm Hg to 120/80 mm/Hg is normal.

Blood pressure after the endoscopy procedure

时间窗: within first 5 minutes after the endoscopy procedure

90/60 mm Hg to 120/80 mm/Hg is normal.

Post-endoscopy pain

时间窗: Pain severity reported in the first 5 minutes after the endoscopy procedure

Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst Pain

Heart rate before the endoscopy procedure

时间窗: Just before the endoscopy procedure

60 to 100 beats per minute is normal.

Heart rate after the endoscopy procedure

时间窗: Heart rate per minute reported in the first 5 minutes after the endoscopy procedure

60 to 100 beats per minute is normal.

Pain intensity before endoscopy

时间窗: Pain intensity reported within the first 5 minutes prior to the endoscopy procedure

Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst Pain

Respiration rate before the endoscopy procedure

时间窗: Just before the endoscopy procedure

12 to 20 breaths per minute is normal.

Body temperature after endoscopy procedure

时间窗: within first 5 minutes after endoscopy procedure

Normal Body temperature; 36 to 37-5 degrees is normal.

Post-endoscopy anxiety state

时间窗: Anxiety state reported within the first 10 minutes after the endoscopy procedure

The statements in the state anxiety scale were answered as "not at all", "a little", "a lot" and "totally" according to the feelings of the person. A total score of 20-80 is obtained from the scale. A low score indicates a low level of anxiety, and a high one indicates a high level of anxiety. The score obtained from the scale, on the other hand, indicates mild anxiety between 20-39, moderate anxiety between 40-59 and severe anxiety between 60-80.

Anxiety state before endoscopy

时间窗: Anxiety state reported within the first 10 minutes before the endoscopy procedure

The statements in the state anxiety scale were answered as "not at all", "a little", "a lot" and "totally" according to the feelings of the person. A total score of 20-80 is obtained from the scale. A low score indicates a low level of anxiety, and a high one indicates a high level of anxiety. The score obtained from the scale, on the other hand, indicates mild anxiety between 20-39, moderate anxiety between 40-59 and severe anxiety between 60-80.

Body temperature before the endoscopy procedure

时间窗: Just before the endoscopy procedure

Normal Body temperature; 36 to 37-5 degrees is normal.

Respiration rate after endoscopy procedure

时间窗: Respiratory rate/minute reported in the first 5 minutes after the endoscopy procedure

12 to 20 breaths per minute is normal.

次要结局

  • Patient opinions on the effect of virtual reality application on pain(Two hours after endoscopy)
  • Patient opinions on the effect of virtual reality application on anxiety(Two hours after endoscopy)
  • Patient opinions on endoscopy(Two hours after endoscopy)
  • Patient opinions on virtual reality glasses and its application(Two hours after endoscopy)

研究者

发起方
İBRAHİM NAS
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

İBRAHİM NAS

Lecturer

Ataturk University

研究点 (1)

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