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临床试验/NCT05460104
NCT05460104招募中不适用

Impact of the Use of Virtual Reality Exposure Therapy on Body Image After Bariatric Surgery

University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年3月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
2
主要终点
Body Shape Questionnaire

研究概览

简要总结

The purpose ot the study is to assess the effectiveness of the use of VERT on improving body image at 12 months in patients who underwent bariatric surgery in the weight stabilization phase (between 18 and 30 months after bariatric) presenting dissatisfaction with their body image compared to standard follow-up in post-bariatric surgery (lack of specific management of body image).

详细描述

Virtual reality therapy makes it possible to work on the integration of proprioceptive information via the reproduction of environments close to reality and therefore allow the patient to accept his new identity. This tool is used in an increasing number of indications and in particular in the management of dysmorphophobia in patients suffering from anorexia nervosa. In the context of bariatric surgery, only case reports have been published so far. Significant improvements in the body satisfaction scores of patients have been showed, in patients who had undergone bariatric surgery who presented bodily dissatisfaction after 6 weeks of virtual reality. However, larger numbers, longer follow-up periods and more rigorous methodologies are needed to confirm the impact of this practice. The hypothesis of the study is that virtual reality therapy could improve body image in patients who are dissatisfied with their body image after bariatric surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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

  • inclusion criteria: patients who underwent bariatric surgery in the weight stabilization phase (between 18 and 30 months after surgery) presenting dissatisfaction with their body image according to the BSQ (score ≥ 111), to be affiliated to the French social security system. The prior, free and informed consent of the patient shall be obtained.

排除标准

  • patients with disabling nausea (Motion Sickness) from previous use of a virtual reality headset, patients who had from post-bariatric reconstructive surgery, epileptic patients, decompensation of a psychiatric pathology

结局指标

主要结局

Body Shape Questionnaire

时间窗: Between inclusion and 12 months after.

Average variation of the Body Shape Questionnaire (BSQ). BSQ is a 34 questions questionnaire, for each question the answer is 1 to 6, 1 for "never" and 6 for "always". (score ≥ 111, moderate body image concern)

次要结局

  • Quality of Life, Obesity and Dietetics questionnaire assess quality of life(Between Month 6 and Month 12)
  • Change weight(Between Month 6 and Month 12)
  • Body Image Assessment for Obesity questionnaire(Between Month 6 and Month 12)
  • Self-esteem(Between Month 6 and Month 12)
  • Change weight(Between inclusion day and Month 3)
  • Body Image Assessment for Obesity questionnaire(Between inclusion day and Month 3)
  • Quality of Life, Obesity and Dietetics questionnaire assess quality of life(Between inclusion day and Month 3)
  • Self-esteem(Between inclusion day and Month 3)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (2)

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