Audiovisual Aid Pilot Study
Completed · Not applicable
Conditions studied: Stress, Psychological
In brief
Little is known about perioperative stress responses and possible anxiety mitigating factors like audiovisual aids or IV sedation. Most studies use surrogate markers and retrospective questionnaires, and are not based on real-time gathered data. Skin conductance measurements allow the sympathetic discharge to be evaluated down to fractions of a second and enable us to continuously monitor stress responses as skin conductance responses/per second during the perioperative management. In our study, the investigators propose to examine the effect of personal audiovisual equipment (audio/video goggles) on perioperative stress, pain, and overall experience in patients undergoing ambulatory meniscectomy under spinal anesthesia. Patients will be randomly assigned to either receive traditional sedation or light sedation in addition to audiovisual equipment. The investigators hope to determine outcome estimates of the use of this equipment on stress levels using skin conductance measurements, request for further sedation, postoperative pain levels and analgesic consumption, time to discharge readiness, and overall patient satisfaction, and collect thus far unavailable data on the stress response to perioperative stresses (such as IV insertion and spinal placement) in order to allow for power analyses for future studies.
Key facts
- Study ID
- NCT02506673
- Run by
- Hospital for Special Surgery, New York
- People needed
- 26
- Starts
- 2016-01-14
- Expected to finish
- 2017-07-01
- Last updated by the study team
- 2024-12-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients scheduled for primary, ambulatory, arthroscopic meniscectomy under spinal anesthesia
You may not qualify if…
- Patients with psychiatric disease and those on antidepressants
- Contraindications to spinal anesthesia or allergy to study medication
- Age < 18 years
- Patients with audiovisual impairments
- Patients with inability to communicate in English or understand the study requirements
- Chronic pain patients +/- opioid use
- Patients with (neuro)dermatoses encompassing the hand
- Patients with pacemakers
- Patients with diabetes or known neuropathic disease
- Patients with a history of epilepsy or seizure disorder
- Patients with a history of claustrophobia
- Patients with a history of epilepsy
- Patients with prior history of epilepsy or seizure disorder
- Patients undergoing a revision or open procedure
Where it is running
- Hospital for Special Surgery (HSS) — New York, New York, United States
Full record on ClinicalTrials.gov
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