Audiovisual Aid Pilot Study

Not Applicable

Completed

Conditions: Stress, Psychological

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

Registration Number: NCT02506673

Lead Sponsor: Hospital for Special Surgery, New York

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 26

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sedation only with skin conductance monitor	Skin Conductance Monitor	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.
Sedation & audiovisual aids with skin conductance monitor	Zeiss, Cinema ProMED (audiovisual equipment)	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.
Sedation & audiovisual aids with skin conductance monitor	Skin Conductance Monitor	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.
Sedation only with skin conductance monitor	Midazolam	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.
Sedation & audiovisual aids with skin conductance monitor	Midazolam	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.

Primary Outcome Measures

Name	Time	Method
Skin Conductance Response	Measured in 5 minute intervals, from holding area until PACU discharge.	Primary outcome will be number of skin conductance responses per second (SCR/sec) and amplitude of skin conductance responses averaged over time in 5 minute intervals and at key time points such before, during and after insertion of an IV, discussion with surgeon, anesthesiologist, immediately before leaving the holding area, immediately after entering the OR, during application of monitors, before and after administration of sedatives, before, during and after spinal insertion, incision, immediately prior to leaving the OR, after arrival at PACU and monitors are placed, before discharge from the PACU.

Secondary Outcome Measures

Name	Time	Method
Respiratory Rate	Measured from preop to postop	The maxmimum change in postoperative respiratory rate from holding area until PACU discharge.
Client Satisfaction Questionnaire (CSQ-8)	PACU upon spinal resolution	The client satisfaction questionnaire (CSQ-8) is a standardized satisfaction measure and was used to collect patient feedback on the audio visual devices. Response options differ, but all are on a 4-point scale. Scores range from 8 to 32, with higher values indicating higher satisfaction. Patient feedback (CSQ8) in PACU upon spinal resolution provider feedback (form sent to providers at end of surgery day)
Systolic and Diastolic Blood Pressure	Measured from preop to postop	The maximum change in postoperative systolic and diastolic blood pressure from holding area until PACU discharge.
Request of Sedation/Termination of AVA	From consent until spinal resolution (avg 6 hs)	Request of Sedation/Termination of AVA (After consent has been obtained until spinal resolution in the recovery room, average of 6 hours)
Number of Participants With Complications	Intraoperatively and in the recovery room, average of 3 hours	The percentage of patients who experienced complications (headache, transient neurologic symptoms, nausea and vomiting, ...)
Narcotic Consumption	Preop until 24 hours after surgery (holding area until POD 1)	Narcotic consumption "intraop", "postop" and "POD1"
Beats Per Minute (BPM)	Measured from preop to postop	The change in heart rate from holding area until PACU discharge.
Number of Patients Who Requested Additional Sedation	In the operating room	Number of patients who requested additional sedative medication in the operating room.
Pain Numerical Rating Scale (NRS) Levels	Holding area, Postop (PACU, 30 minutes after arrival to PACU and POD1)	Pain scores at rest will be collected from patients using the numerical rating scale (NRS), which asks patients to report their level of pain on a scale from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain. NRS levels in holding area, PACU until discharge from the PACU and one day after surgery, postop day 1.
State-Trait Anxiety Inventory Questionnaire (STAI)	holding area and PACU	Questionnaire to measure state anixety levels based on a 4-point likert scale and consists of 40 questions. The questionnaire measures two types of anxiety: state anxiety and trait anxiety. State anxiety relates to anxiety about an event, while trait anxiety in anxiety level as a personal characteristic. Scores can range from 20 to 80 and higher scores correlate with more anxiety.
Number of Providers That Were Satisfied With Their Experience With the Audio-visual Aids	Sent to providers at end of surgery.	Anesthesia providers were asked to provide feedback on their experience with the audio-visual aids when the randomization was for the use of the device. This was collected upon surgery end.
Heidelberg Peri-anaesthetic Questionnaire	At PACU upon spinal resolution.	The questionnaire consists of 38 questions assessing perioperative satisfaction about five identified themes: trust and atmosphere; fear; discomfort; treatment by personnel; and information and waiting. The questions are rated on a 4-point Likert scale ranging from 0 (unimportant to me) to 3 (very important to me). Higher scores indicate higher levels of satisfaction. Patient satisfaction (Heidelberg Peri-Anaesthetic Questionnaire) in PACU upon spinal resolution.