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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality-Assisted Hypnotherapy+Physiotherapy Group | Experimental | 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. |
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| Standard Treatment Group | Active Comparator | Participants in this arm will undergo a conventional physical therapy program for 3 weeks (15 sessions) supervised by physiotherapists. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 low back pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity | 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. | Assessed at baseline, immediately after treatment (3 weeks), and at 1- and 3-month follow-ups. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Functional Status | Functional status will be assessed using the Roland-Morris Disability Index. | Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups. |
| Change in Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tugba Sahbaz, Associate Professor | Contact | +90444 1997 | 6021 | piskint@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beykent University Faculty of Medicine, Physical Therapy Unit | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41212507 | Derived | Menekseoglu AK, Asik HK, Sahbaz T, Is EE. Mind over pain: VR-based hypnotherapy for chronic non-specific low back pain - a randomised controlled trial. Ir J Med Sci. 2026 Feb;195(1):177-185. doi: 10.1007/s11845-025-04158-1. Epub 2025 Nov 10. |
| Label | URL |
|---|---|
| Related Info | View source |
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| 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 |
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Quality of life will be measured using the EQ-5D-5L questionnaire.
| Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups. |
| Reduction in Analgesic Use | The number of days per week participants use nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen for pain management will be recorded. | Baseline and weekly throughout the 3-month follow-up period. |
| Change in Anxiety and Depression Levels | Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS). | Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups. |
| Reduction in Healthcare Utilization | 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. | Assessed retrospectively at baseline and at the 3-month follow-up. |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
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