임상 레이더 AI | ||
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임상시험 NCT06333418 (VR/WN_colon)은(는) 내시경 검사 중 사고에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Effects of VR and Glass WF Colonoscopy (VR/WN_colon) 135 비대면
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06333418 (VR/WN_colon)은(는) 내시경 검사 중 사고에 대해 알아보는 중재연구입니다. 현재 상태는 대상자모집전이며, 2024년 4월 3일부터 참여 신청이 가능합니다. 135명의 참여자를 모집할 예정입니다. Suleyman Demirel University이(가) 진행하는 이 연구는 2024년 6월 8일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2024년 3월 27일에 갱신되었습니다.
간단한 개요
Background: Today, colonoscopy is widely used in many diseases, especially in the screening and diagnosis of colorectal cancers. Colonoscopy is considered a procedure that disturbs the patient's comfort because it is a very invasive and painful procedure. Along with physical discomfort during the procedure, it triggers emotional disturbances such as fear, and anxiety in the patient.
Purpose: To examine the effect of...
더 보기상세한 설명
Background: Today, colonoscopy is widely used in many diseases, especially in the screening and diagnosis of colorectal cancers. Colonoscopy is considered a procedure that disturbs the patient's comfort because it is a very invasive and painful procedure. Along with physical discomfort during the procedure, it triggers emotional disturbances such as fear, and anxiety in the patient.
Purpose: To examine the effect of...
더 보기공식 제목
The Effect of Virtual Rain Forest and Glass Waterfall on Satisfaction, Comfort, Anxiety, and Vital Signs Undergoing Colonoscopy
질환명
내시경 검사 중 사고출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- VR/WN_colon
- VR/WF
NCT 번호
실제 연구 시작일
2024-04-03
최신 업데이트 게시
2024-03-27
예상 연구 완료일
2024-06-08
계획된 등록 인원
135
연구종류
중재연구
단계/상
해당 없음
상태
대상자모집전
키워드
virtual reality
glass waterfall
satisfaction
comfort
colonoscopy
glass waterfall
satisfaction
comfort
colonoscopy
주요 목적
지지요법
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
이중맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Virtual Reality Glasses Before the colonoscopy procedure, 360-degree VR video scenes will be watched to patients 30 minutes using VR head device. | Virtual Reality Glasses Group Before the colonoscopy procedure, 360-degree VR video scenes will be watched to patients 30 minutes using VR head device. |
실험적Glass waterfall Before the colonoscopy procedure, patients will watch and listen 30 minutes a portative glass waterfall | Glass waterfall Before the colonoscopy procedure, patients will watch and listen 30 minutes a portative glass waterfall |
비개입control group Patients of the control group, will not receive any intervention except for applied routine hospital colonoscopy procedures | 해당 없음 |
주요결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Patient Information Form | This form, which will be created by the researcher; Patients' age, gender, education level, marital status, employment status, income level, chronic disease status, previous surgery, complaints about coming to the hospital, having knowledge about colonoscopy, whether they would prefer the current method if they need to have colonoscopy again, It consists of a total of 14 questions questioning the use of additional sedation and painkillers during the procedure | the fundamental characteristics of the patients will be filled in 40 minutes before the colonoscopy procedure |
Visual Analogue Scale (VAS) | This scale developed by Price (1983) will be used in the research to determine the level of tolerance, comfort and satisfaction. It is a scale in which the distance between the two ends with a minimum value of 0 on one end and a maximum value of 10 on the other end is measured with a 10 cm ruler. In this context; The patient is explained that there are two endpoints and that he is free to mark any place between them that fits the severity of his pain.
The distance between the beginning of "no comfort, tolerance and satisfaction" and this point marked by the patient is measured and recorded in centimeters. It has been shown that the VAS is a valid tool for the measurement of psychological and health variables such as pain and satisfaction, which is widely used in clinical studies | Change from Baseline Visual Analogue Scale in 50 minutes |
State and Trait Anxiety Scale (STAI) | It is a self-assessment questionnaire developed by Spielberger et al. and consists of short assessments. The STAI includes 40 four-point Likert-type items ranging from "None" to "Completely". The validity and reliability of the STAI in Turkey were established by Öner and Le Compte. The STAI includes two separate scales, the State Anxiety Score (SAS) and the Trait Anxiety Score (TAS). The SAS requires the person to describe how they feel at a certain moment and under certain conditions and to respond by taking into account their feelings about the situation they are in. On the other hand, the TAS requires the person to describe how they usually feel. Higher scores indicate increased anxiety level. In the Turkish validity and reliability study, Cronbach's alpha reliability coefficients were between 0.83 and 0.87 for the TAS and between 0.94 and 0.96 for the SAS. | Change from Baseline The State and Trait Anxiety Scale in 50 minutes |
The Patient Observation Form | This form will be created by the researcher based on the literature review, the vital signs (pulse (min), respiratory rate (min), systolic blood pressure (mmHg), diastolic blood pressure (mmHg), and oxygen saturation values (%)) of the patients before and after the procedure will be recorded the form. Researcher will has a automatic blood pressure monitor and a probe device for recording vital signs in the endoscopy unit. While the patients' vital signs will being taken, a fully automatic blood pressure monitor will be used to measure blood pressure and pulse. To measure the respiratory rate, the patient placed his hand on his chest and his chest movements will be counted and recorded for one minute. Oxygen saturation level will be measured from the index finger with a probe device.Data will be collected by recording all vital measurement values on a single form. The form will similar to forms commonly used in nursing research for patient vital signs. | Change from Baseline The Patient Observation Form in 50 minutes |
Pulse rate before colonoscopy procedure | 60 to 100 beats per minute is normal. It will be recorded 40 minutes (pretest) and 10 minutes (posttest) before the gastroscopy procedure | Change from Baseline Pulse rate in 50 minutes |
Respiratory rate before colonoscopy procedure | 12 to 18 breaths per minute is normal. It will be recorded 40 minutes (pretest) and 10 minutes (posttest) before the gastroscopy procedure | Change from Baseline Respiratory rate in 50 minutes |
Systolic and diastolic blood pressure before colonoscopy procedure | 90/60 mm Hg to 120/80 mm Hg is normal. It will be recorded 40 minutes (pretest) and 10 minutes (posttest) before the gastroscopy procedure | Change from Baseline Systolic and diastolic blood pressure in 50 minutes |
Oxygen saturation values before colonoscopy procedure | Normal oxygen saturation usually ranges from 95 to 100%. It will be recorded 40 minutes (pretest) and 10 minutes (posttest) before the gastroscopy procedure | Change from Baseline Oxygen saturation values in 50 minutes |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
건강한 참가자 허용
네
- 18 aged and over
- Written and verbal consent to participate in the study,
- Being conscious (person, place and time orientation),
- Undergoing colonoscopy for the first time
- Having vision, hearing and communication problems
- Having any psychiatric and cognitive/mental mental health problems, disease (dementia, etc.),
- Diagnosed with visual, auditory and / or balance disorders,
연구 책임자
Hasan Genç, 책임연구자, Asistant Professor, Dicle University
연구 대표 연락처
연락처: Hasan GENC, PhD, +0955319887307, [email protected]
시험기관의 위치 정보가 없습니다.