Virtual Reality to Reduce Anxiety and Pain During Orthopedic Surgery Under Spinal Anesthesia

Evaluation of the Effectiveness of Virtual Reality as an Adjunct to Standard Care in Managing Perioperative Anxiety and Pain in Patients Undergoing Lower Limb Orthopedic Surgery Under Spinal Anesthesia

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202507660086282

Enrollment

100

Registered

2025-07-17

Start date

2025-06-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaesthesia

Interventions

Immersive Virtual Reality Session Using SHINECON VR Headset

Standard of Care

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Inclusion Criteria : - Age between 19 and 64 years - American Society of Anesthesiologists (ASA) physical status classification I or II (Annex 1) - Scheduled for lower limb orthopedic surgery under spinal anesthesia - Provided informed consent to participate in the study - Non-Inclusion Criteria : - Patient refusal to participate in the study - Contraindications to virtual reality (VR) (Patients with cognitive or psychiatric disorders, Claustrophobia, Uncontrolled epilepsy, Visual and/or auditory impairments preventing the use of VR) - Contraindications to midazolam: known hypersensitivity to benzodiazepines or any excipient of the product - Patients currently taking anxiolytic medications - Contraindications to regional anesthesia (spinal anesthesia), (Coagulation disorders, Shock or uncompensated hypovolemia, Unstable arterial hypertension, Decompensated heart failure, Severe aortic or mitral stenosis, Intracranial hypertension, Infection near the puncture site, Progressive neurological disorders, Allergy to local anesthetics, Technical difficulties in performing spinal anesthesia)

Exclusion criteria

Exclusion criteria: - Failure of spinal anesthesia requiring conversion to general anesthesia - Occurrence of an anesthetic or surgical complication - Occurrence of an adverse effect related to virtual reality, such as (Dizziness, Ocular or muscular contractions triggered by light stimulation, Signs of discomfort : eye strain, blurred vision, disorientation, imbalance, anxiety attack, headache, nausea, vomiting)

Design outcomes

Primary

Measure	Time frame
We expect that the use of immersive virtual reality (VR) during lower limb orthopedic surgery under spinal anesthesia will: Significantly reduce perioperative anxiety levels compared to standard care	—

Secondary

Measure	Time frame
We expect that the use of immersive virtual reality (VR) during lower limb orthopedic surgery under spinal anesthesia will: - Lower the intensity of perioperative pain as measured by validated pain scales - Decrease the need for sedative and analgesic medications during the perioperative period - Contribute to more stable hemodynamic parameters during and after the procedure - Increase overall satisfaction among patients, as well as anesthesia and surgical teams	—

Measure

Time frame

We expect that the use of immersive virtual reality (VR) during lower limb orthopedic surgery under spinal anesthesia will: - Lower the intensity of perioperative pain as measured by validated pain scales - Decrease the need for sedative and analgesic medications during the perioperative period - Contribute to more stable hemodynamic parameters during and after the procedure - Increase overall satisfaction among patients, as well as anesthesia and surgical teams

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Countries

Tunisia

Contacts

Public ContactFedi BEN DHAOU

PhD Student in Public Health

bendhaoufedi5@gmail.com+21656780354

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026