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

NCT06697795 — Not applicable, Not yet recruiting, 60 participants, University of Beykent

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Registry	NCT06697795
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	60 (Estimated)
Sponsor	University of Beykent (Other)
Conditions	Chronic Neck Pain, Neck Pain
Interventions	Virtual Reality-Assisted Hypnotherapy, Standard Physical Therapy (Device, other)
Dates	start 2024-12-02 (estimated), primary completion 2025-04-01 (estimated), completion 2025-07-01 (estimated), first posted 2024-11-20, last updated 2024-11-20
Locations	1 site in Turkey (Türkiye)

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Virtual Reality-Assisted Hypnotherapy+Physiotherapy Group	Experimental	Device: Virtual Reality-Assisted Hypnotherapy	Participants in this arm will undergo a conventional physical therapy program for 3 weeks (15 sessions) supervised by physiotherapists. Additionally, during each physical therapy session, participants will receive a 20-minute Virtual Reality (VR)-assisted hypnotherapy session using the HypnoVR software.
Standard Treatment Group	Active comparator	Other: Standard Physical Therapy	Participants in this arm will undergo a conventional physical therapy program for 3 weeks (15 sessions) supervised by physiotherapists.

Virtual Reality-Assisted Hypnotherapy (Device): 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.
Standard Physical Therapy (Other): 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

+Outcome measures

Primary outcomes

Change in Pain Intensity [Assessed at baseline, immediately after treatment (3 weeks), and at 1- and 3-month follow-ups.]: The primary outcome is the percentage change in pain intensity, measured using the Visual Analog Scale (VAS). A reduction of ≥30% in the VAS score from baseline is considered clinically significant.

Secondary outcomes

Change in Functional Status [Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.]: Functional status will be assessed using the Neck Disability Index (NDI). Improvement in NDI scores reflects better functionality and reduced disability related to chronic neck pain.
Change in Quality of Life [Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.]: Quality of life will be measured using the Short Form-12 (SF-12) questionnaire.
Reduction in Analgesic Use [Baseline and weekly throughout the 3-month follow-up period.]: The number of days per week participants use nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen for pain management will be recorded.
Change in Anxiety and Depression Levels [Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.]: Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS).
Reduction in Healthcare Utilization [Assessed retrospectively at baseline and at the 3-month follow-up.]: Healthcare utilization, including the number of clinic visits (Family Medicine, Physical Therapy, Orthopedics) and cervical imaging (X-ray, MRI), will be recorded for the 3 months prior to and after the intervention.

+Eligibility

Sex: All, ages: 50 Years to 80 Years

Inclusion Criteria:

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

Exclusion Criteria:

* 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).

+Locations (1)

Facility	City	Country	Status
Beykent University Faculty of Medicine, Physical Therapy Unit	Istanbul	Turkey (Türkiye)