The Effect of Virtual Reality Application Used During Endoscopy on Pain, Anxiety and Vital Signs: A Mixed Methods Study
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
- 是
入选标准
- •Inclusion criteria:
- •Inclusion criteria for the quantitative study;
- •18 years and older,
- •who can read and write Turkish,
- •without mental problems,
- •Having no vision, hearing or perception problems,
- •Diagnostic endoscopy was performed,
- •No sedation before and during the procedure
- •who volunteered to participate in the study,
- •Those who have not taken analgesics in the last 8 hours
- •Qualitative research inclusion criteria;
- •in the experimental group,
- •who volunteered to participate in the research
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
研究组 & 干预措施
Intervention/treatment
- Implementation steps 1-4 of the Control Group will be done.
- The patient will be informed about the virtual reality application.
- The patient will be told that they can remove their glasses at any time and stop participating in the study.
- 2 minutes before the endoscopy process starts, the previously determined video will be started by putting on the Virtual Reality Glasses.
- Glasses will be worn from the beginning to the end of the procedure.
- The patient will be observed during the procedure. The data obtained during the observation will be noted.
- After the endoscopy procedure; "State Anxiety Scale", "Visual Comparison Scale" will be re-applied and vital signs will be measured and recorded in the Patient Follow-up Form.
- After the endoscopy procedure, patients will be given an interview appointment on the same day to collect the data of the qualitative part of the study.
- "Semi-Structured Interview Form" will be applied in the interview.
干预措施: Experimental group (Other)
Control group
- Hands will be washed.
- The right patient will be determined, the procedure will be explained to the patient and permission will be obtained.
- A "Patient Identification Form" will be applied to the individual before the endoscopy procedure.
- Before the endoscopy procedure; "State Anxiety Scale" will be applied in the first 10 minutes, and "Visual Comparison Scale" will be applied in the first 5 minutes. Vital signs will be measured within the first 5 minutes and recorded on the Patient Follow-up Form. Then the individual will be taken to the endoscopy procedure.
- The patient will be observed during the procedure. The data obtained during the observation will be noted.
- After the endoscopy procedure; "State Anxiety Scale", "Visual Comparison Scale" will be applied again and vital signs will be measured and recorded in the Patient Follow-up Form.
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 virtual reality glasses and its application(Two hours after endoscopy)
- 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)
研究者
İBRAHİM NAS
Lecturer
Ataturk University