Cost-Effectiveness Analysis of a Virtual Reality-Assisted Hypnotherapy Program on Quality of Life in Patients with Chronic Neck Pain: a Multicenter, Randomized, Prospective, Comparative, Open-Label, Parallel-Group Study

NCT06697795 | Not Yet Recruiting

• 1 other identifier: E-66291034-202.3.02-6297
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Neck Pain; Neck Pain

Keywords

hypnotherapy; virtual reality

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (5)

• Change in Functional Status

  Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.

• Change in Quality of Life

  Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.

• Reduction in Analgesic Use

  Baseline and weekly throughout the 3-month follow-up period.

• Change in Anxiety and Depression Levels

  Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.

• Reduction in Healthcare Utilization

  Assessed retrospectively at baseline and at the 3-month follow-up.

Study Arms (2)

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.

Device: Virtual Reality-Assisted Hypnotherapy

Standard Treatment Group

ACTIVE COMPARATOR

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

Other: Standard Physical Therapy

Interventions

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 neck pain.

Virtual Reality-Assisted Hypnotherapy+Physiotherapy Group

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

Standard Treatment Group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 50 and 80 years.
• Chronic neck pain lasting for more than 3 months.

You may not qualify if:

• History of spinal surgery.
• Beck Depression Inventory (BDI) score \>16.
• Presence of neurological deficits or concurrent neurological diseases.
• Medical conditions incompatible with the use of VR headsets (e.g., vision problems, epilepsy).
• Pregnancy.
• Recent changes in medication for chronic pain within the past 3 months (e.g.,- Pregabalin, Gabapentin, Duloxetine).

Sponsors & Collaborators

• University of Beykent: lead

Study Sites (1)

Beykent University Faculty of Medicine, Physical Therapy Unit

Istanbul, Turkey (Türkiye)

Location

Related Links

• Related Info

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tugba Sahbaz, Associate Professor

CONTACT

+90444 1997; piskint@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: December 2, 2024
• Primary Completion: April 1, 2025
• Study Completion: July 1, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

TU (1)