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临床试验/NCT07375472
NCT07375472已完成不适用

he Effect of Virtual Reality Headset, Squishy (Squeeze Toy), and Poetry Reading on Postoperative Pain Control After Total Knee Arthroplasty

Izmir Tinaztepe University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年1月14日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
1
主要终点
Pain Intensity (VAS)

研究概览

简要总结

This randomized controlled trial evaluates the effectiveness of three distraction techniques-virtual reality (VR) headset, squishy (squeeze toy), and poetry reading-on postoperative pain control in adults undergoing total knee arthroplasty. Participants are randomized into four parallel groups (three intervention arms and one usual care control). Pain intensity is assessed using the Visual Analog Scale (VAS), with primary assessment at 24 hours after surgery.

详细描述

Total knee arthroplasty is a common orthopedic procedure that can be associated with significant postoperative pain. In addition to standard pharmacological analgesia, non-pharmacological approaches such as distraction techniques may help reduce perceived pain by redirecting attention away from nociceptive stimuli. This single-center, parallel-group randomized controlled trial will be conducted in the Orthopedics and Traumatology Clinic of Osmaniye State Hospital in Türkiye. Eligible adults (≥18 years) undergoing total knee arthroplasty will be randomized using a stratified block randomization approach based on baseline pain severity (VAS 0-3, 4-6, 7-10) to ensure balanced allocation across groups. The intervention arms include (1) VR headset distraction, (2) use of a squishy (squeeze toy) as a tactile distraction method, and (3) poetry reading as a cognitive distraction method. The control group receives usual postoperative care without a structured distraction intervention. All groups follow the same postoperative analgesia protocol. The primary outcome is postoperative pain intensity measured by VAS at 24 hours after surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years or older
  • Undergoing total knee arthroplasty
  • Hospitalized in the postoperative period at Osmaniye State Hospital
  • Able to communicate and complete pain assessment (Visual Analog Scale)
  • Provides written informed consent
  • Managed under the same postoperative analgesia protocol and operated by the same surgeon (as per study protocol)

排除标准

  • Severe cognitive impairment or inability to provide valid pain assessment
  • Postoperative complications that may interfere with participation or pain assessment
  • Contraindication to the assigned distraction method (e.g., intolerance to wearing a VR headset, severe nausea/dizziness, claustrophobia)
  • Refusal or withdrawal of consent

研究组 & 干预措施

Virtual Reality (VR) Headset

Experimental

Participants will receive routine postoperative care and standard analgesia according to the hospital protocol. In addition, they will receive a structured distraction intervention using a virtual reality (VR) headset during the postoperative pain period while hospitalized (e.g., within the first 24 hours after surgery). The VR content is delivered under supervision at the bedside as a non-pharmacological distraction method.

干预措施: VR Distraction (Behavioral)

Squishy (Squeeze Toy)

Experimental

Participants will receive routine postoperative care and standard analgesia according to the hospital protocol. In addition, they will use a squishy (squeeze toy) as a tactile distraction method during the postoperative pain period while hospitalized (e.g., within the first 24 hours after surgery). Participants are instructed to use the squeeze toy during episodes of pain/discomfort as a non-pharmacological distraction technique.

干预措施: Tactile Distraction With Squishy (Behavioral)

Poetry Reading

Experimental

Participants will receive routine postoperative care and standard analgesia according to the hospital protocol. In addition, they will perform poetry reading as a cognitive distraction method during the postoperative pain period while hospitalized (e.g., within the first 24 hours after surgery). Poetry reading is provided as a structured non-pharmacological distraction intervention at the bedside.

干预措施: Poetry Reading Distraction (Behavioral)

Usual Care Control

No Intervention

articipants will receive routine postoperative care and standard analgesia according to the hospital protocol. No structured distraction intervention (VR, squishy, or poetry reading) will be provided.

结局指标

主要结局

Pain Intensity (VAS)

时间窗: 24 hours after surgery

Visual Analog Scale pain score (0=no pain, 10=worst pain).

次要结局

  • Pain Intensity (VAS) by Pain Severity Strata(24 hours after surgery)

研究者

发起方
Izmir Tinaztepe University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Berna Dizer

Assistant professor

Izmir Tinaztepe University

研究点 (1)

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