Clinical trial NCT02506673: Audiovisual Aid Pilot Study
Official title: The Effect of Audiovisual Aids on Perioperative Stress Response, Pain and Overall Experience - a Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Keywords: Audiovisual Aids
Perioperative Period
Anxiety
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2015-07-23
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Skin Conductance Response
timeFrame: Measured in 5 minute intervals, from holding area until PACU discharge.
Secondary outcomes:
measure: Beats Per Minute (BPM)
timeFrame: Measured from preop to postop
measure: Systolic and Diastolic Blood Pressure
timeFrame: Measured from preop to postop
measure: Respiratory Rate
timeFrame: Measured from preop to postop
measure: Number of Patients Who Requested Additional Sedation
timeFrame: In the operating room
measure: Pain Numerical Rating Scale (NRS) Levels
timeFrame: Holding area, Postop (PACU, 30 minutes after arrival to PACU and POD1)
measure: Narcotic Consumption
timeFrame: Preop until 24 hours after surgery (holding area until POD 1)
measure: State-Trait Anxiety Inventory Questionnaire (STAI)
timeFrame: holding area and PACU
measure: Heidelberg Peri-anaesthetic Questionnaire
timeFrame: At PACU upon spinal resolution.
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: PACU upon spinal resolution
measure: Number of Providers That Were Satisfied With Their Experience With the Audio-visual Aids
timeFrame: Sent to providers at end of surgery.
measure: Request of Sedation/Termination of AVA
timeFrame: From consent until spinal resolution (avg 6 hs)
measure: Number of Participants With Complications
timeFrame: Intraoperatively and in the recovery room, average of 3 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery (HSS)
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Stavros G. Memtsoudis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: