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
NCT ID: NCT06698354
Last Updated: 2024-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2024-12-02
2025-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Virtual Reality-Assisted Hypnotherapy+Physiotherapy Group
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.
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 low back pain.
Standard Treatment Group
Participants in this arm will undergo a conventional physical therapy program for 3 weeks (15 sessions) supervised by physiotherapists.
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
Interventions
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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 low back pain.
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
Eligibility Criteria
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Inclusion Criteria
* Chronic neck pain lasting for more than 3 month
Exclusion Criteria
* 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.).
50 Years
80 Years
ALL
No
Sponsors
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University of Beykent
OTHER
Responsible Party
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TUĞBA ŞAHBAZ
Associate Professor
Locations
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Beykent University Faculty of Medicine, Physical Therapy Unit
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Related Info
Other Identifiers
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E-66291034-202.3.02-6546
Identifier Type: -
Identifier Source: org_study_id
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