跳至主要内容
临床试验/NCT05437796
NCT05437796招募中不适用

Using the Immersive Virtual Reality for the Management of Anxiety and Pain in Orthopedic Surgery

Centre Hospitalier de Montauban2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
2
主要终点
Measurement of general anxiety Spielberger

研究概览

简要总结

Interventions may be a particular source of anxiety for some patients, and the management of surgical pain is still a real challenge. In order to avoid the side effects of medications, a lot of caregivers are turning to complementary medicines.

The prosthetic knee surgeries are painful and anxiety-provoking acts. At the hospital of Montauban, to relieve patients' pain, we offer them a therapeutic regimen with regional anesthesia (spinal anesthesia). We also use accompaniment hypnotic virtual reality to the management of anxiety and pain patients.

详细描述

Interventions may be a particular source of anxiety for some patients, and the management of surgical pain is still a real challenge. In order to avoid the side effects of medications, a lot of caregivers are turning to complementary medicines.

The prosthetic knee surgeries are painful and anxiety-provoking acts. At the hospital of Montauban, to relieve patients' pain, we offer them a therapeutic regimen with regional anesthesia (spinal anesthesia). We also use accompaniment hypnotic virtual reality to the management of anxiety and pain patients.

Despite a high level of approval of patients (according our satisfaction surveys) concerning hypnotic virtual reality, we want to evaluate our practice. Thus, in the future, we can invest in this type of material and make it available to a larger number of patients, but only if complementary care proves its effectiveness.

The purpose of this study is to evaluate the effectiveness of hypnotic virtual reality support on the patient's state of anxiety before and after prosthetic knee surgeries under spinal anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible patients for prosthetic knee surgery under spinal anesthesia
  • Patient who has received appropriate information and has provided informed consent
  • Patient with French social security system

排除标准

  • Patient under general anaesthesia
  • Patients treated in conventional inpatient care or in the traditional ambulatory circuit
  • Patient under guardianship or trusteeship
  • Minor patient < 18 years of age
  • Patient who has not provided informed consent or who cannot submit to the study protocol
  • Patient suffering from cognitive disorders (ex: Alzheimer's disease)
  • Patients who are deaf or hearing-impaired or epilepsy
  • Infected patient or identified as carrier of an infectious agent

结局指标

主要结局

Measurement of general anxiety Spielberger

时间窗: 60 minutes

Questionnaire general anxiety Spielberger: This questionnaire assesses your anxiety in life in general, and refers to trait anxiety. It is a stable disposition of personality. The total score ranges from 20 - 80. The following guidelines are recommended for the interpretation of scores: Minus than 35 normal or no anxiety; 36 to 45, mild anxiety; 46 to 55, moderate anxiety; 56 to 65 severe anxiety; more than 65 severe anxiety.

Measurement of state of anxiety Spielberger

时间窗: 60 minutes

Questionnaire state of anxiety Spielberger: The Anxiety-State Scale assesses the feelings of apprehension, tension, nervousness and anxiety that the subject feels anxiety when the situation. The total score ranges from 20 - 80. The following guidelines are recommended for the interpretation of scores: Minus than 35 normal or no anxiety; 36 to 45, mild anxiety; 46 to 55, moderate anxiety; 56 to 65 severe anxiety; more than 65 severe anxiety.

次要结局

  • Effectiveness of hypnotic virtual reality:(48 hours)

研究者

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

Edmundo PEREIRA DE SOUZA NETO

Principal Investigator

Centre Hospitalier de Montauban

研究点 (2)

Loading locations...

相似试验