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Not yet recruiting NCT06697795

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

No phase Interventional Chronic Neck Pain Neck Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality-Assisted Hypnotherapy, Standard Physical Therapy.
Who it may be relevant to
Registry conditions: Chronic Neck Pain, Neck Pain. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

  • Device 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.
  • Other 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

Primary outcome measures

  • Change in Pain Intensity [Time frame: Assessed at baseline, immediately after treatment (3 weeks), and at 1- and 3-month follow-ups.]
Secondary outcome measures (5)
  • Change in Functional Status [Time frame: Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.]
  • Change in Quality of Life [Time frame: Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.]
  • Reduction in Analgesic Use [Time frame: Baseline and weekly throughout the 3-month follow-up period.]
  • Change in Anxiety and Depression Levels [Time frame: Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.]
  • Reduction in Healthcare Utilization [Time frame: Assessed retrospectively at baseline and at the 3-month follow-up.]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Beykent University Faculty of Medicine, Physical Therapy Unit — Istanbul

Identifiers

NCT: NCT06697795 · E-66291034-202.3.02-6297

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗