Combining Virtual Reality and Hypnosis to Alleviate Chronic Pain in Elderly Patients with Hand Arthritis

Официальное название

Combining Virtual Reality and Hypnosis to Alleviate Chronic Pain in Elderly Patients with Hand Arthritis: a Pilot Randomized Clinical Trial

Обзор

The goal of this pilot randomized clinical trial is to test the efficacy of an intervention combining virtual reality and hypnosis on decreasing pain and improving quality of life in elderly patients with hand arthritis. The main questions it aims to answer are: * Does the intervention allow for an improvement of patient reported outcomes related to pain and quality of life? * Does the intervention allow for an improvement of physiological variables related to pain? Researchers will compare intervention group to a passive control group (i.e., waiting list with treatment as usual). Participants in the intervention group will be provided a virtual reality headset allowing them to beneficiate from the virtual reality and hypnosis modules.

Вмешательства

• Поведенческое Virtual reality: Beach
  Session 1 or 2 (counterbalanced): Exposure to a beach landscape
• Поведенческое Virtual Reality: Forest
  Session 1 or 2 (counterbalanced): Exposure to a forest landscape
• Поведенческое Hypnosis: Magic Hand
  Session 3 or 4 (counterbalanced): Exposure to a hypnosis technique: the magic hand
• Поведенческое Hypnosis: Pain Manipulation
  Session 3 or 4 (counterbalanced): Exposure to a hypnosis technique: manipulating the pain
• Поведенческое Session 1bis - 1 week
  Repetition of the Session 1 one week after Session 4
• Поведенческое Follow-up
  Repetition of the Session 1 three weeks after Session 4

Первичные конечные точки

• Perceived pain [Срок оценки: Intervention group: Two times per week (before and after each session)/Control group: One time per week, For all: from enrollment to the end of intervention at 6 weeks and at a 3 weeks follow-up]

Вторичные конечные точки (6)

• Anxiodepressive symptoms [Срок оценки: Intervention group: Two times per week (before and after each session)/Control group: One time per week, For all: from enrollment to the end of intervention at 6 weeks and at a 3 weeks follow-up]
• Quality of life [Срок оценки: Intervention group: Two times per week (before and after each session)/Control group: One time per week, For all: from enrollment to the end of intervention at 6 weeks and at a 3 weeks follow-up]
• Fatigue [Срок оценки: From enrollment, each week during 6 weeks, Intervention group: Two times per week (before and after each session)]
• Relaxation [Срок оценки: From enrollment, each week during 6 weeks, Intervention group: Two times per week (before and after each session)]
• Perceived changes [Срок оценки: From Session 2, each week during 5 weeks, Intervention group: Two times per week (before and after each session)]
• Cybersickness [Срок оценки: From enrollment, each week during 6 weeks, Intervention group: One time per week (after each session)]

Критерии участия

Критерии включения

• Fluent in French
• Being diagnosed with hand arthrisis
• Reporting an invalidating chronic pain in hand related to the condition

Критерии исключения

• Experiencing a medical condition altering the ability to consent or participate in the study
• Experiencing cognitive disorders; Experiencing sensory disorders (deafness, blindness)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Fournier V, Simard MF, Yuen SY, Guine J, Rousseaux F, Lebeau J, Jerbi K, Richebe P, Landry M, Rainville P, Ogez D. Combining virtual reality and hypnosis to alleviate chronic pain in elderly with hand arthritis: protocol for a randomised phase II clinical trial. BMJ Open. 2025 Oct 5;15(10):e103841. doi: 10.1136/bmjopen-2025-103841. PMID 41047257

Идентификаторы

NCT: NCT06833905 · 2024-3539

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗