- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07843511
The Effect of Virtual Reality Headsets on Pain, Anxiety, Patient Satisfaction, and Physiological Parameters in Patients Undergoing Open-Heart Surgery
The Effect of Virtual Reality Headsets on Pain, Anxiety, Patient Satisfaction, and Physiological Parameters in Patients Undergoing Open-Heart Surgery: A Randomized Controlled Trial
This randomized controlled trial aims to investigate the effects of virtual reality headset use on pain, anxiety, patient satisfaction, and physiological parameters in patients undergoing open-heart surgery. Participants will be randomly assigned to two groups: the virtual reality group and the control group. Pain levels, anxiety levels, satisfaction levels, and physiological parameters will be assessed both before and after the procedure. The study aims to determine whether this non-pharmacological method improves postoperative pain, anxiety, patient satisfaction, and physiological parameters.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Izmir, 터키 (Türkiye)
- 모병
- Dokuz Eylul University
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연락하다:
- Principal Investigator
- 전화번호: +90 232 412 4779
- 이메일: gizemgoktuna@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Aged 18 and older
- Who have not previously undergone open-heart surgery
- Non-emergency, elective surgeries
- Who have not taken pain medication 4-6 hours prior to the procedure
- Who have a numerical pain scale score of 3 or higher prior to the procedure
- Patients with sufficient cognitive ability to tolerate the virtual reality headset application
- Patients who voluntarily agree to participate in the study
- Patients extubated on the second postoperative day
- Patients with no history of chronic pain (e.g., arthritis)
- Being alert and oriented enough to communicate (Glasgow Coma Scale 15)
- Not being addicted to alcohol or drugs
- Not using anxiolytics
- Having no psychological problems (such as depression or anxiety disorders)
- Being able to read and understand Turkish
Exclusion Criteria:
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• Under 18 years of age
- With vision or hearing loss
- Clinically unstable
- With a known history of epilepsy, vertigo, or limited mobility
- With a surgical incision or scar on the face that prevents wearing VR goggles
- Chronic opioid use or use of psychiatric medications
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Virtual Reality Group
For patients admitted to the ward for surgery, the researcher will have them complete the State Anxiety Scale and the Satisfaction Scale one day before surgery. On the third postoperative day in the clinic, the researcher will fit patients with virtual reality goggles, and the patient will watch nature-themed videos-such as forest scenes, beach walks, and parks-for 10 minutes. After 10 minutes, the virtual reality session will end. Immediately after the intervention and 30 minutes later, the same researcher will have the patients complete the Numerical Pain Scale, the State Anxiety Scale, the Numerical Satisfaction Scale, and the Physiological Parameters Monitoring Form. |
One day before surgery, the researcher will have participants in this group complete the State Anxiety Scale and the Satisfaction Scale. On the third postoperative day at the clinic, the researcher will fit patients with virtual reality goggles, and the patient will watch nature-themed videos-such as forest scenes, beach walks, and parks-for 10 minutes. After 10 minutes, the virtual reality session will end. Immediately after the intervention and 30 minutes later, the same researcher will have the patients complete the Numerical Pain Scale, the State Anxiety Scale, the Numerical Satisfaction Scale, and the Physiological Parameters Monitoring Form. This distraction technique aims to reduce pain perception and anxiety levels, increase patient satisfaction during the procedure, and improve physiological parameters.
다른 이름들:
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간섭 없음: Control Group
Patients admitted to the ward for surgery will complete the State Anxiety Scale and the Satisfaction Scale administered by the researcher one day before surgery. Patients will be admitted to the clinic on the third postoperative day, and their care will continue to be provided by the nurse responsible for their care as part of routine clinical practice. The researcher will not perform any additional interventions. At the same time as the group receiving the virtual reality headset intervention, the researcher will again have patients complete the Numerical Pain Scale, State Anxiety Scale, Numerical Satisfaction Scale, and Physiological Parameters Monitoring Form. (Measurements will be taken during the preoperative period; however, patients who do not meet the inclusion criteria postoperatively will not be included in the study.) |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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postoperative pain
기간: The second day after surgery, immediately before the procedure, immediately after the procedure, and 30 minutes later.
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Pain intensity will be measured using a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain) immediately after the procedure. Measurements will be taken three times: on the second day after surgery, immediately before the procedure, immediately after the procedure, and 30 minutes later. |
The second day after surgery, immediately before the procedure, immediately after the procedure, and 30 minutes later.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Preoperative and postoperative anxiety levels
기간: One day before surgery; the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
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Anxiety levels will be assessed using the State Anxiety Inventory-Short Form (STAIS-S). The scale measures temporary anxiety levels. Scores range from 20 to 80. Measurements will be taken four times: one day before surgery; on the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure. Higher scores indicate higher (worse) anxiety. |
One day before surgery; the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
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Pre- and post-surgery satisfaction levels
기간: One day before surgery; the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
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Patient satisfaction will be assessed using a Visual Analog Scale (VAS) ranging from 0 (not at all satisfied) to 10 (extremely satisfied). Measurements will be taken four times: one day before surgery; on the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure. Higher scores indicate greater satisfaction. |
One day before surgery; the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
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Systolic Blood Pressure
기간: On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
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Systolic blood pressure will be measured in millimeters of mercury (mmHg). Higher values indicate higher systolic blood pressure. |
On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
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Diastolic Blood Pressure
기간: On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
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Diastolic blood pressure will be measured in millimeters of mercury (mmHg). Higher values indicate higher diastolic blood pressure. |
On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
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Pulse Rate
기간: On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
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Pulse rate will be measured in beats per minute (beats/min). |
On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
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Respiratory Rate
기간: On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
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Respiratory rate will be measured in breaths per minute (breaths/min). |
On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .