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N/A N=26 Randomized Treatment

Audiovisual Aid Pilot Study

Stress, Psychological

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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