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

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-02

Study Completion Date

2025-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Pain Low Back Pain Chronic Low Back Pain (CLBP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Virtual Reality-Assisted Hypnotherapy

Intervention Type 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.

Standard Treatment Group

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

Group Type ACTIVE_COMPARATOR

Standard Physical Therapy

Intervention Type 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

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.

Intervention Type DEVICE

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

Intervention Type OTHER

Eligibility Criteria

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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.).
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Beykent

OTHER

Sponsor Role lead

Responsible Party

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TUĞBA ŞAHBAZ

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beykent University Faculty of Medicine, Physical Therapy Unit

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Tugba Sahbaz, Associate Professor

Role: CONTACT

+90444 1997 ext. 6021

Facility Contacts

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Tugba Sahbaz, Assoc Prof

Role: primary

Related Links

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Other Identifiers

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E-66291034-202.3.02-6546

Identifier Type: -

Identifier Source: org_study_id

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