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VR-Cognitive Behavioral Therapy Prehabilitation for Spinal Deformity Surgery
VR-Cognitive Behavioral Therapy Prehabilitation for Spinal Deformity Surgery

NCT07777679

Not Yet RecruitingNA

Sponsor: University of California, Irvine

Conditions: Degenerative Spine Disease, Spinal Stenosis Lumbar

Interventions: Virtual Reality-Based CBT Prehabilitation (VR-CBT), CBT Prehabilitation without Virtual Reality

Countries: United States

The goal of this clinical trial is to learn whether a virtual reality-based cognitive behavioral therapy (VR-CBT) prehabilitation program can improve recovery and quality of life for adults undergoing elective spine surgery. The main questions it aims to answer are: Does participating in an 8-week VR-CBT prehabilitation program before surgery improve physical function and pain-related outcomes at 12 months after surgery? Does VR-CBT prehabilitation reduce postoperative anxiety, depression, and pain interference compared with usual preoperative care? Researchers will compare participants who receive the VR-CBT prehabilitation program plus usual care to participants who receive usual preoperative care alone to see if the VR-CBT program leads to better recovery and patient-reported outcomes. Participants will: Use a VR headset at home to complete structured CBT-based prehabilitation sessions over 8 weeks before surgery. Attend routine clinic visits and complete questionnaires about pain, function, mood, and quality of life before surgery and through 12 months after surgery. Allow the research team to review their medical records for information about surgery, complications, and postoperative recovery.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Adults between 18 and 75 years old.

Diagnosis of thoracolumbar adult spinal deformity (ASD), including but not limited to adult scoliosis, kyphosis, or spondylolisthesis, confirmed radiographically using SRS-Schwab classification criteria.

Scheduled for elective spinal surgery involving fusion of more than four spinal levels.

Moderate to severe chronic pain, assessed using the Visual Analog Scale (VAS) or Numeric Rating Scale (NRS).

Ability to participate in an 8-week preoperative prehabilitation program.

Adequate cognitive functioning and English language skills to engage in CBT or VR-CBT treatments.

Ability to provide written informed consent and adhere to study procedures and follow-up visits.

Exclusion Criteria:

* Neurological conditions that significantly impact cognition or mobility.

Active spinal infection, malignancy, or significant spinal trauma.

Unmanaged medical conditions that could affect participation in the study.

Pregnancy or plans to become pregnant during the study period.

Severe visual impairment, claustrophobia, or other conditions that prevent safe use of VR technology.

Cognitive impairment preventing adherence to study procedures.

History of non-compliance with medical treatment or failure to adhere to study visits and follow-up.
Locations (2)
  • Irvine, California, United States
  • Newport Beach, California, United States