N/A
N=26
Audiovisual Aid Pilot Study
Stress, Psychological
Bottom Line
View on ClinicalTrials.gov: NCT02506673 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Skin Conductance Response — NA; NA skin conductance responses per second
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Zeiss, Cinema ProMED (audiovisual equipment) (Device); Midazolam (Drug); Skin Conductance Monitor (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Skin Conductance Response |
NA; NA | — |
| SECONDARY Beats Per Minute (BPM) |
71.7; 66.8; 17; 17; 2; -6 | — |
| SECONDARY Systolic and Diastolic Blood Pressure |
82.8; 79.6; 3; 2; -2; -4 | — |
| SECONDARY Respiratory Rate |
17.2; 16.9; 5; 4; -1; 1 | — |
| SECONDARY Number of Patients Who Requested Additional Sedation |
5; 3 | — |
| SECONDARY Pain Numerical Rating Scale (NRS) Levels |
1.9; 2.2; 0; 0; 0.6; 0 | — |
| SECONDARY Narcotic Consumption |
2.3; 3.5; 9.8; 10.8; 11.0; 11.5 | — |
| SECONDARY State-Trait Anxiety Inventory Questionnaire (STAI) |
33.5; 32.3; 33.4; 31.8; 26.1; 27.1 | — |
| SECONDARY Heidelberg Peri-anaesthetic Questionnaire |
97.2; 98.9 | — |
| SECONDARY Client Satisfaction Questionnaire (CSQ-8) |
31.5 | — |
| SECONDARY Number of Providers That Were Satisfied With Their Experience With the Audio-visual Aids |
07 | — |
| SECONDARY Request of Sedation/Termination of AVA |
13; 13 | — |
| SECONDARY Number of Participants With Complications |
0; 0; 0; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02506673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.