Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

New York, New York 10021


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

2014-394


NCT ID:

NCT02506673


Secondary ID:


Study Acronym:


Brief Title:

Audiovisual Aid Pilot Study


Official Title:

The Effect of Audiovisual Aids on Perioperative Stress Response, Pain and Overall Experience - a Randomized Controlled Pilot Study


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Hospital for Special Surgery, New York


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

26


Enrollment Type:

Actual


Overall Contact Information

Official Name:Stavros G. Memtsoudis, MD, PhD
Principal Investigator
Hospital for Special Surgery, New York

Study Dates

Start Date:January 14, 2016
Completion Date:July 2017
Completion Type:Actual
Primary Completion Date:May 2017
Primary Completion Type:Actual
Verification Date:March 2018
Last Changed Date:March 8, 2018
First Received Date:July 2, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Incidence of complications
Time Frame:Intraoperatively and in the recovery room, average of 3 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Requests for sedation/termination of audiovisual aids
Time Frame:After consent has been obtained until spinal resolution in the recovery room, average of 6 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Provider Feedback
Time Frame:Sent to providers at end of surgery day
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:CSQ-8 Questionnaire
Time Frame:Before discharge (an average of 5 hours after hospital admission)
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Heidelberg Peri-anaesthetic Questionnaire
Time Frame:Before discharge (an average of 5 hours after hospital admission)
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:State-Trait Anxiety Inventory Questionnaire (STAI)
Time Frame:After consent day of surgery (an average of 1 hour after hospital admission) and before discharge (a
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Narcotic consumption
Time Frame:For time in the recovery room (an average of 2 hours) and cumulative 24 hours after discharge
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Pain numerical rating scale (NRS) levels
Time Frame:After admission to the recovery room, cumulative every 30 minutes until discharge, an average of 2 h
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Number of requests for additional sedation
Time Frame:In the operating room, an average of 1 hour
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Respiratory rate
Time Frame:In the operating room and in the recovery room, an average time of 3 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Blood pressure
Time Frame:In the operating room and in the recovery room, an average time of 3 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Heart rate
Time Frame:In the operating room and in the recovery room, an average time of 3 hours
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Skin conductance response
Time Frame:Participants will be followed for the duration of hospital stay, an expected average of 6 hours
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Device
Name:Zeiss, Cinema ProMED (audiovisual equipment)
Arm Name:Sedation & audiovisual aids with skin conducta
Intervention Type:Drug
Name:Midazolam
Arm Name:Sedation only with skin conductance monitor
Intervention Type:Device
Name:Skin Conductance Monitor
Arm Name:Sedation only with skin conductance monitor

Study Arms

Study Arm Type:Experimental
Arm Name:Sedation & audiovisual aids with skin conductance monitor
Description: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.
Study Arm Type:Active Comparator
Arm Name:Sedation only with skin conductance monitor
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Hospital for Special Surgery, New York

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.