Cost-Effectiveness Analysis of a Virtual Reality-Assisted Hypnotherapy Program on Quality of Life in Patients with Chronic Neck Pain: a Multicenter, Randomized, Prospective, Comparative, Open-Label, Parallel-Group Study

Обзор

This randomized, prospective study aims to evaluate the effectiveness and cost-efficiency of a Virtual Reality (VR)-assisted hypnotherapy program on quality of life in patients with chronic neck pain. The study compares a VR-assisted hypnotherapy group to a standard treatment group. Both groups will undergo a conventional physical therapy program supervised by physiotherapists for 3 weeks (15 sessions). The VR-assisted hypnotherapy group will receive additional sessions utilizing the HypnoVR software, which delivers relaxing virtual environments. Outcomes will be assessed immediately after treatment, at 1 month, and at 3 months post-treatment. Primary endpoints include pain reduction measured by the Visual Analog Scale (VAS). Secondary endpoints include functionality, quality of life, anxiety, depression, sleep quality, healthcare costs, and treatment adherence. Statistical analyses will determine the efficacy and economic impact of this innovative therapy for chronic neck pain management.

Вмешательства

• Устройство Virtual Reality-Assisted Hypnotherapy
  Virtual Reality-Assisted Hypnotherapy utilizes HypnoVR software delivered through VR glasses to provide a relaxing virtual environment. The intervention is integrated into a standard physical therapy program, with participants receiving 20-minute VR-assisted hypnotherapy sessions during each of the 15 supervised physical therapy sessions over a 3-week period. This approach aims to improve pain management, quality of life, and adherence to treatment in patients with chronic neck pain.
• Другое Standard Physical Therapy
  Participants in the control group will undergo a standard physical therapy program focused on the cervical region, consisting of 15 sessions over 3 weeks. Each session will be supervised by physiotherapists in a clinical setting and will include traditional physical therapy techniques such as therapeutic exercises

Первичные конечные точки

• Change in Pain Intensity [Срок оценки: Assessed at baseline, immediately after treatment (3 weeks), and at 1- and 3-month follow-ups.]

Вторичные конечные точки (5)

• Change in Functional Status [Срок оценки: Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.]
• Change in Quality of Life [Срок оценки: Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.]
• Reduction in Analgesic Use [Срок оценки: Baseline and weekly throughout the 3-month follow-up period.]
• Change in Anxiety and Depression Levels [Срок оценки: Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.]
• Reduction in Healthcare Utilization [Срок оценки: Assessed retrospectively at baseline and at the 3-month follow-up.]

Критерии участия

Критерии включения

• Age between 50 and 80 years.
• Chronic neck pain lasting for more than 3 months.

Критерии исключения

• History of spinal surgery.
• Beck Depression Inventory (BDI) score >16.
• Presence of neurological deficits or concurrent neurological diseases.
• Medical conditions incompatible with the use of VR headsets (e.g., vision problems, epilepsy).
• Pregnancy.
• Recent changes in medication for chronic pain within the past 3 months (e.g.,- Pregabalin, Gabapentin, Duloxetine).

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

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Beykent University Faculty of Medicine, Physical Therapy Unit — Istanbul

Идентификаторы

NCT: NCT06697795 · E-66291034-202.3.02-6297

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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