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NCT06698354

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

Not yet recruiting NA Last updated 21 November 2024
What this trial tests

NA trial testing Virtual Reality-Assisted Hypnotherapy in Chronic Pain in 60 participants. Not yet recruiting.

Timeline
2 December 2024
Primary endpoint
1 April 2025
1 July 2025

Quick facts

Lead sponsorUniversity of Beykent
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment60
Start date2 December 2024
Primary completion1 April 2025
Estimated completion1 July 2025
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

University of Beykent

Who can join

Adults 50 to 80, any sex, with Chronic Pain or Low Back Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Mind over pain: VR-based hypnotherapy for chronic non-specific low back pain - a randomised controlled trial.
    Menekseoglu AK, Asik HK, Sahbaz T, İs EE. · · 2026 · PMID 41212507 · DOI 10.1007/s11845-025-04158-1

Verify or expand the search:

Other trials of Virtual Reality-Assisted Hypnotherapy

Trials testing the same drug.

Other recruiting trials for Chronic Pain

Currently open trials in the same condition.

Other University of Beykent trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06698354.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing