Anxiety and Fear, Pain, Postoperative, Stress
Conditions
Brief summary
The aim of this research study is to evaluate the impact of immersive VR exposure on preoperative anxiety and pain. Additionally, to assess whether VR intervention would significantly alleviate pain and anxiety levels of patients undergoing complex spinal surgeries. Investigators hypothesize that the application of pre-operative VR-based intervention will alleviate anxiety and pain both pre- and post-operatively when it is used as treatment to complement standard care compared to standard routine care alone, and that it may lead to better outcomes and higher satisfaction in patients.
Interventions
DEVICEVirtual Reality
The VR group will be exposed to a unified 15-minute VR video via phone using a VR device and goggles after receiving routine standard care. A 360˚ video with an immersive audio-visual environment describing pre-operative and post-operative experience on the day of the surgery will be provided, by which they can get accustomed to the environment and procedures associated with the surgery. Background audio will be provided through headsets, and the video will be directed by a neurosurgeon filmed using a Max 360 action VR camera. In the video, actors, neurosurgeons, and nurses will re-enact a typical day for a mock patient undergoing surgery, plus routine post-operative care, including the post-operative immediate recovery room and rehabilitation care by neurosurgeons, psychologists, and physiotherapists in the ward. Patients are allowed to move around freely so that they can experience all aspects of the virtual space, and are encouraged to ask questions at the end.
Sponsors
Medical University of Lodz
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients between 25-70 years old, undergoing an elective spinal surgery. * Patient's admission prior to surgery day (at least 1 day). * Expected hospital stay - 2 days. * Capable of providing informed consent and participate in the study follow-up questionnaire. * Patients speak Polish.
Exclusion criteria
* Congestive heart failure, hypertension and anti-hypertensive medications * Adrenal insufficiency * Alcohol addiction (evaluated by CAGE/AUDIT) and substance addiction (evaluated by DUDIT) * Cognitive impairment (evaluated by MMSE, MoCA) * Cerebrovascular diseases, ophthalmological diseases (strabismus, diplopia, retina degeneration, glaucoma), neurological conditions (epilepsy or seizure, dementia, vertigo, dizziness, motion sickness) - evaluated by: history taking, examination, vision test (Ishihara test), Simulator Sickness Questionnaire * Auditory impairment * Psychiatric illness (schizophrenia, bipolar disorder, psychotic depression) - (evaluated by MINI questionnaire) * Patients with neuropathic pain * Use of sedative drugs, anti-depressants, anxiolytics, and anti-epileptic drugs * Intracranial functional lesions (patients after TBI (Traumatic Brain Injury), cognitive or executive dysfunction) * Patient with high risk due to major and emergency operations * Claustrophobia * GCS \< 15
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stress (STAI-S) and Pain (VAS) | 24 hours postoperatively | The Primary outcome for this trial is the change in the intensity of pre-operative anxiety measured by the State-Trait Anxiety Inventory (STA-I) scale and pain measured by visual Analogue Scale (VAS). These outcomes will be measured pre-operatively on the day before surgery. Measurements will be made again post-operatively - within 24 hours. Pre-operative and post-operative STAI-S and VAS will be compared for data analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction (EVAN-G) and Postoperative Stress (PSS-10) | 24 hours postoperatively | The Secondary outcome will be the patients' quality of life and satisfaction measured by Evaluation du Vecu de l'Anesthesie Generale (EVAN-G) questionnaire and postoperative stress measured by Perceived Stress Scale PSS-10 within 24 hours and used for data analysis, since the level of satisfaction and the stress caused by thinking time spent at pain can contribute to an increased perception of pain. |
Countries
Poland
Contacts
Primary ContactRedwan Jabbar, MD, PhD (Candid.)
Outcome results
None listed