An interventional study of Virtual Reality-Assisted Hypnotherapy and Standard Physical Therapy in Chronic Neck Pain and Neck Pain, sponsored by University of Beykent. Not yet recruiting at 1 site in Turkey. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by University of Beykent · Not applicable, Interventional, and Treatment
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.
1,233 studies on the registry are indexed under Neck Pain; 256 are open to participants now.
This study's planned enrollment of 60 is above the median of 51 across 1,005 interventional studies indexed under Neck Pain.
Browse Neck Pain studies →University of Beykent is the lead sponsor of 54 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
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.
Device: Virtual Reality-Assisted Hypnotherapy
Participants in this arm will undergo a conventional physical therapy program for 3 weeks (15 sessions) supervised by physiotherapists.
Other: Standard Physical Therapy
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.
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
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.
Time frame: Assessed at baseline, immediately after treatment (3 weeks), and at 1- and 3-month follow-ups.
Change in Functional Status
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.
Time frame: Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.
Change in Quality of Life
Quality of life will be measured using the Short Form-12 (SF-12) questionnaire.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Assessed retrospectively at baseline and at the 3-month follow-up.
Plan to share: Undecided
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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University of Beykent