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临床试验/NCT07039812
NCT07039812招募中不适用

The Effect of Virtual Reality and Eye Mask Application During Dressing After Coronary Artery Bypass Graft Surgery on Sternotomy Pain, Anxiety, and Physiological Parameters

Istanbul University - Cerrahpasa1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年2月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
Visual Analog Scale (VAS)

研究概览

简要总结

This study aims to evaluate the effects of virtual reality (VR) and eye mask (EM) applications on pain, anxiety, and physiological parameters during dressing after Coronary Artery Bypass Graft (CABG) surgery.

Postoperative dressing procedures, especially after sternotomy, often cause significant pain and anxiety in patients. These issues can negatively impact recovery and increase the need for medication. Non-pharmacological interventions such as VR and EM may help reduce these symptoms.

In this randomized controlled trial, 90 patients are divided into three groups: VR group, EM group, and a control group receiving standard care. Pain and anxiety levels are monitored baseline, immediately after, and 15 minutes after both the first and second dressing procedures. Physiological parameters are measured baseline, during, immediately after, and 15 minutes after both dressing procedures. Additionally, analgesic use is followed baseline and immediately after each dressing procedure. The study is conducted in a cardiovascular intensive care unit in Istanbul, Türkiye. It is expected that the findings will support the integration of VR and EM as effective, low-cost, and non-invasive options for postoperative care, improving patient comfort and healthcare quality.

详细描述

This randomized controlled experimental study investigates the effects of virtual reality (VR) and eye mask (EM) applications on sternotomy pain, anxiety, and physiological parameters during postoperative dressing following Coronary Artery Bypass Graft (CABG) surgery.Pain and anxiety during dressing procedures after CABG surgery can negatively affect the recovery process, increase stress responses, prolong hospital stays, and raise the need for medication. Non-pharmacological interventions such as VR and EM are considered effective strategies for managing these symptoms.

The study includes 90 patients, randomly assigned to one of three groups: VR Group: Patients watched 360-degree nature-themed videos using a virtual reality headset during dressing. EM Group: Patients wore an eye mask during dressing. Control Group: Patients received standard care without any additional intervention. The study is being conducted in the Cardiovascular Surgery Intensive Care Unit of a public hospital located in Istanbul, Türkiye.

Inclusion criteria include adult patients undergoing CABG for the first time, ASA classification I-II-III, fully conscious, oriented, cooperative, and willing to provide informed consent. Exclusion criteria include patients with infections or complications, psychiatric disorders, or sensory impairments such as hearing or vision problems. Pain and anxiety levels are assessed at three time points during both the first and second dressing procedures: baseline, immediately after dressing, and 15 minutes after dressing. Physiological parameters (blood pressure, pulse rate, respiratory rate, oxygen saturation) are measured at four time points: baseline, immediately after dressing, and 15 minutes after dressing. Analgesic use is recorded baseline and immediately after each dressing. This study is one of the first to compare VR and EM interventions in the context of high-risk, postoperative cardiac surgery. The results are expected to contribute to evidence-based nursing practices, improve patient comfort in the postoperative period, and support the use of cost-effective, drug-free alternatives for pain and anxiety management in clinical care.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults aged 18-65 years
  • •First-time coronary artery bypass graft (CABG) surgery for coronary artery disease
  • •ASA physical status I, II, or III
  • •Conscious, oriented, and cooperative
  • •Able to communicate verbally
  • •Provided written informed consent

排除标准

  • •Presence of sternal wound infection or inflammation
  • •Intubated at the time of assessment
  • •Undergoing revision surgery
  • •Receiving anesthesia or sedation in the ICU
  • •Experiencing intraoperative or postoperative complications
  • •Inability to speak Turkish
  • •Hearing or visual impairment
  • •Diagnosed psychiatric or cognitive disorder
  • •Diagnosis of epilepsy
  • •Body mass index (BMI) ≥ 30
  • •Participation in another clinical trial during the same period

研究组 & 干预措施

Virtual Reality Group

Experimental

Participants in this group will watch 360-degree nature-themed videos through a virtual reality headset (Oculus meta quest 2) during both the first and second sternotomy dressing procedures.

干预措施: Virtual Reality Headset (Device)

Eye Mask Group

Experimental

Participants in this group will wear an eye mask during both the first and second sternotomy dressing procedures.

干预措施: Eye Mask (Device)

Control Group

No Intervention

Participants in this group will receive standard postoperative care during dressing, with no additional interventions applied.

结局指标

主要结局

Visual Analog Scale (VAS)

时间窗: Baseline, immediately after, and 15 minutes after first and second dressing

Pain intensity will be measured using the Visual Analog Scale (VAS) at three time points: before, immediately after, and 15 minutes after both the first and second sternotomy dressing procedures.

State-Trait Anxiety Inventory (STAI-II)

时间窗: Baseline, immediately after, and 15 minutes after first and second dressing

State anxiety levels (STAI-I) will be measured before, immediately after, and 15 minutes after both the first and second dressing procedures. Trait anxiety (STAI-II) will be measured only once, before surgery.

次要结局

  • Physiological Parameters (Blood pressure)(Baseline, during, immediately after, and 15 minutes after first and second dressing)
  • Physiological Parameters (Pulse)(Baseline, during, immediately after, and 15 minutes after first and second dressing)
  • Physiological Parameters (SpO₂)(Baseline, during, immediately after, and 15 minutes after first and second dressing)
  • Physiological Parameters (Respiratory rate )(Baseline, during, immediately after, and 15 minutes after first and second dressing)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tugce Bozkurt Elmas

PhD Candidate

Istanbul University - Cerrahpasa

研究点 (1)

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