Audiovisual Aid Pilot Study

NCT02506673 | Completed Results

• 1 other identifier: 2014-394
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress, Psychological

Keywords

Audiovisual Aids; Perioperative Period; Anxiety

Outcome Measures

Primary Outcomes (1)

• Skin Conductance Response

  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.

  Measured in 5 minute intervals, from holding area until PACU discharge.

Secondary Outcomes (12)

• Beats Per Minute (BPM)

  Measured from preop to postop

• Systolic and Diastolic Blood Pressure

  Measured from preop to postop

• Respiratory Rate

  Measured from preop to postop

• 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)

Study Arms (2)

Sedation only with skin conductance monitor

ACTIVE COMPARATOR

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.

Drug: Midazolam; Device: Skin Conductance Monitor

Sedation & audiovisual aids with skin conductance monitor

EXPERIMENTAL

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.

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

Interventions

Zeiss, Cinema ProMED (audiovisual equipment) DEVICE

Sedation & audiovisual aids with skin conductance monitor

Midazolam DRUG

Sedation & audiovisual aids with skin conductance monitor; Sedation only with skin conductance monitor

Skin Conductance Monitor DEVICE

Sedation & audiovisual aids with skin conductance monitor; Sedation only with skin conductance monitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for primary, ambulatory, arthroscopic meniscectomy under spinal anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery (HSS)

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Stress, Psychological; Anxiety Disorders

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Danya DeMeo, Research Assistant
• Organization: Hospital for Special Surgey

demeod@hss.edu

2127742678

Study Officials

• Stavros G. Memtsoudis, MD, PhD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: July 23, 2015
• Study Start: January 14, 2016
• Primary Completion: May 1, 2017
• Study Completion: July 1, 2017
• Last Updated: December 27, 2024
• Results First Posted: February 10, 2020

Record last verified: 2024-04

Locations

US (1)