Audiovisual Aid Pilot Study

Hospital for Special Surgery (HSS)

Status: Completed

Conditions: Stress, Psychological

Treatments: Drug: Midazolam; Device: Zeiss, Cinema ProMED (audiovisual equipment); Device: Skin Conductance Monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT02506673

2014-394

Details and patient eligibility

About

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.

Full description

PLEASE NOTE: After conducting the interim analysis and plotting the skin conductance data, we have determined that the graphs are not consistent enough to draw any conclusions. Given the technical difficulties we have encountered with the Med-Storm Stress Detector, as well as the labor intensity associated with it, we have decided that we will no longer use it from patient 14 on. We will not mark the time points and hand movements described in the protocol, as this data was used to understand the skin conductance data. We will continue to enroll patients to complete this pilot/exploratory study, as the other secondary outcomes--in particular, the surveys--could provide valuable information.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for primary, ambulatory, arthroscopic meniscectomy under spinal anesthesia

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Sedation only with skin conductance monitor

Active Comparator group

Description:

Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge.

Treatment:

Device: Skin Conductance Monitor

Drug: Midazolam

Sedation & audiovisual aids with skin conductance monitor

Experimental group

Description:

Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge.

Treatment:

Device: Skin Conductance Monitor

Device: Zeiss, Cinema ProMED (audiovisual equipment)

Drug: Midazolam