The Effect of Audiovisual Aids on Perioperative Stress Response, Pain and Overall Experience - a Randomized Controlled Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Midazolam
- Conditions
- Stress, Psychological
- Sponsor
- Hospital for Special Surgery, New York
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Skin Conductance Response
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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
Arms & Interventions
Sedation only with 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.
Intervention: Midazolam
Sedation only with 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.
Intervention: Skin Conductance Monitor
Sedation & audiovisual aids with 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.
Intervention: Zeiss, Cinema ProMED (audiovisual equipment)
Sedation & audiovisual aids with 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.
Intervention: Midazolam
Sedation & audiovisual aids with 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.
Intervention: Skin Conductance Monitor
Outcomes
Primary Outcomes
Skin Conductance Response
Time Frame: 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 Outcomes
- Respiratory Rate(Measured from preop to postop)
- Client Satisfaction Questionnaire (CSQ-8)(PACU upon spinal resolution)
- Systolic and Diastolic Blood Pressure(Measured from preop to postop)
- Request of Sedation/Termination of AVA(From consent until spinal resolution (avg 6 hs))
- Number of Participants With Complications(Intraoperatively and in the recovery room, average of 3 hours)
- Narcotic Consumption(Preop until 24 hours after surgery (holding area until POD 1))
- Number of Patients Who Requested Additional Sedation(In the operating room)
- Pain Numerical Rating Scale (NRS) Levels(Holding area, Postop (PACU, 30 minutes after arrival to PACU and POD1))
- Beats Per Minute (BPM)(Measured from preop to postop)
- State-Trait Anxiety Inventory Questionnaire (STAI)(holding area and PACU)
- Number of Providers That Were Satisfied With Their Experience With the Audio-visual Aids(Sent to providers at end of surgery.)
- Heidelberg Peri-anaesthetic Questionnaire(At PACU upon spinal resolution.)