Clinical trial NCT06698354: Cost-Effectiveness Analysis of a Virtual Reality-Assisted Hypnotherapy Program on Quality of Life in Patients with Chronic Low Back Pain: a Multicenter, Randomized, Prospective, Comparative, Open-Label, Parallel-Group Study
Official title: Cost-Effectiveness Analysis of a Virtual Reality-Assisted Hypnotherapy Program on Quality of Life in Patients with Chronic Low Back Pain: a Multicenter, Randomized, Prospective, Comparative, Open-Label, Parallel-Group Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pain
Low Back Pain
Chronic Low Back Pain (CLBP)
Keywords: hypnotherapy
virtual reality
Lead sponsor: University of Beykent
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 low back 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 low back pain management.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Presence of newly developed neurological deficits.
* Existence of comorbid neurological diseases.
* Medical history unsuitable for the use of virtual reality (VR) glasses (e.g., visual impairment, epilepsy).
* Pregnancy.
* Changes in medication for chronic pain management within the last three months (e.g., Pregabalin, Gabapentin, Duloxetine, etc.).

Primary outcomes:
measure: Change in Pain Intensity
timeFrame: Assessed at baseline, immediately after treatment (3 weeks), and at 1- and 3-month follow-ups.
Secondary outcomes:
measure: Change in Functional Status
timeFrame: Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.
measure: Change in Quality of Life
timeFrame: Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.
measure: Reduction in Analgesic Use
timeFrame: Baseline and weekly throughout the 3-month follow-up period.
measure: Change in Anxiety and Depression Levels
timeFrame: Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.
measure: Reduction in Healthcare Utilization
timeFrame: Assessed retrospectively at baseline and at the 3-month follow-up.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Beykent University Faculty of Medicine, Physical Therapy Unit
Study officials:
References: