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

University of Beykent

Status: Not yet enrolling

Conditions: Chronic Low Back Pain (CLBP); Chronic Pain; Low Back Pain

Treatments: Other: Standard Physical Therapy; Device: Virtual Reality-Assisted Hypnotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06698354

E-66291034-202.3.02-6546

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Virtual Reality-Assisted Hypnotherapy+Physiotherapy Group

Experimental group

Description:

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.

Treatment:

Device: Virtual Reality-Assisted Hypnotherapy

Standard Treatment Group

Active Comparator group

Description:

Participants in this arm will undergo a conventional physical therapy program for 3 weeks (15 sessions) supervised by physiotherapists.

Treatment:

Other: Standard Physical Therapy