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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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06697795
Enrollment
60
Registered
2024-11-20
Start date
2024-12-02
Completion date
2025-07-01
Last updated
2024-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Neck Pain, Neck Pain

Keywords

hypnotherapy, virtual reality

Brief 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.

Interventions

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.

OTHERStandard 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

Sponsors

University of Beykent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Change in Pain IntensityAssessed 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

MeasureTime frameDescription
Change in Functional StatusBaseline, 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 LifeBaseline, 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 UseBaseline 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 LevelsBaseline, 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 UtilizationAssessed 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactTugba Sahbaz, Associate Professor
piskint@gmail.com+90444 1997

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026