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Audiovisual Aid Pilot Study

NCT ID: NCT02506673

Last Updated: 2024-12-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-14

Study Completion Date

2017-07-31

Brief Summary

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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

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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.

Conditions

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Stress, Psychological

Keywords

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Audiovisual Aids Perioperative Period Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

Skin Conductance Monitor

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

Zeiss, Cinema ProMED (audiovisual equipment)

Intervention Type DEVICE

Midazolam

Intervention Type DRUG

Skin Conductance Monitor

Intervention Type DEVICE

Interventions

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Zeiss, Cinema ProMED (audiovisual equipment)

Intervention Type DEVICE

Midazolam

Intervention Type DRUG

Skin Conductance Monitor

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital for Special Surgery, New York

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stavros G. Memtsoudis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

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Hospital for Special Surgery (HSS)

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2014-394

Identifier Type: -

Identifier Source: org_study_id