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临床试验/NCT06436014
NCT06436014尚未招募不适用

Evaluation of the Effect of Virtual Reality Application on Postoperative Pain and Anxiety in Women Aged 50-70 According to the Type of Surgery: A Randomized Controlled Trial

Osmaniye Korkut Ata University4 个研究点 分布在 2 个国家目标入组 76 人开始时间: 2024年7月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
76
试验地点
4
主要终点
The VR application is effective in changing postoperative pain.

研究概览

简要总结

Surgical interventions, while significant milestones in patients' physical recovery processes, can be a major source of concern for patients due to postoperative pain, which is also an important component of postoperative care. If postoperative pain is not managed properly, it can lead to increased levels of anxiety and fear, as well as deterioration in overall comfort and quality of life. The ineffective management of postoperative pain has economic and medical consequences such as patient dissatisfaction, delayed hospital discharge, increased rates of hospital readmission, and dissatisfaction with medical care. Therefore, effective management of postoperative pain is of great importance for patient well-being. Factors associated with postoperative pain have been reported in many studies. For example, being female and the type of surgery. Therefore, considering gender and type of surgery in the management of postoperative pain is crucial to optimize the recovery process for patients. In recent years, research on the use of innovative technologies such as virtual reality in the management of postoperative pain has increased. Virtual reality can reduce postoperative pain by creating a sense of being in a different environment for patients and diverting their attention away from pain.

详细描述

Understanding the use of virtual reality applications in the medical field and their effects on pain perception and sensitivity in women is important. This study aims to evaluate the potential impact of virtual reality technology on pain and anxiety during the postoperative period in women aged 50-70. The research will be conducted at Osmaniye State Hospital. The general hypotheses of this study are that virtual reality application is effective in reducing postoperative pain and anxiety. The sub-hypotheses aim to determine the effect of virtual reality application among women undergoing two different types of surgeries (total knee replacement and hysterectomy). The method used in the research includes a randomized controlled trial design, involving application and control conditions across four different groups. Data will be collected through a questionnaire. The questionnaire will gather participants' demographic information, and their pain levels will be assessed using the Visual Analogue Scale (VAS) while their anxiety levels will be evaluated using the Beck Anxiety Scale. After the pre-test, virtual reality application will be administered to experimental groups with two different types of surgeries. No intervention will be applied to the control group before the post-test. Ethical approval and written informed consent will be obtained from the participants. Participants' postoperative pain and anxiety levels, analgesic usage amounts and frequencies will be recorded, and feedback related to their virtual reality experiences will be obtained. In the study, the rotation method will be used to randomly assign participants to experimental and control groups. The rotation method aims to place each patient sequentially into the next group. For example, the first patient undergoing total knee replacement surgery will be assigned to Group 1, and then the second patient undergoing total knee replacement surgery will be assigned to Group 2, the first patient undergoing hysterectomy surgery will be assigned to Group 3, and the second patient undergoing hysterectomy surgery will be assigned to Group 4. Thus, separate control and application groups will be formed for each type of surgery. This study is original and important as it will be the first study in our country to evaluate the impact of virtual reality on pain and anxiety in 50-70-year-old women according to the type of surgery.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Being between the ages of 50-70,
  • Being female,
  • Having adequate vision and hearing,
  • Having American Society of Anesthesiologists (ASA) physical status classification I and II,
  • Undergoing elective total knee replacement or hysterectomy surgery,
  • Having a similar analgesia protocol,
  • Being on the first postoperative day,
  • Scoring 5 or higher on the Visual Analogue Scale (VAS) assessment,
  • Being able to speak and understand Turkish.

排除标准

  • Having chronic pain,
  • Scoring below 5 on the Visual Analogue Scale (VAS) assessment,
  • Experiencing vertigo or motion-sensitive nausea,
  • Being diagnosed with severe anxiety by a specialist physician,
  • Having claustrophobia,
  • Having head or neck conditions that prevent wearing virtual reality goggles,
  • Having a Glasgow Coma Score <15,
  • Having psychiatric, cognitive, or neurological impairments,
  • Having visual or hearing impairments.

结局指标

主要结局

The VR application is effective in changing postoperative pain.

时间窗: The researcher's first visit to the patient on postoperative day 1.

Pretest with VAS is administered on the first postopera tive day to women aged 50-70 undergoing total knee replacement and hysterectomy. • Subsequently, VR intervention is conducted. • Following the intervention, participants are re-evaluated with VAS.

次要结局

  • The VR application is effective in changing postoperative anxiety.(The researcher's first visit to the patient on postoperative day 1.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Songul Gungor

Lecturer Phd

Osmaniye Korkut Ata University

研究点 (4)

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