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Audiovisual Aid Pilot Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02506673
Enrollment
26
Registered
2015-07-23
Start date
2016-01-14
Completion date
2017-07-31
Last updated
2024-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress, Psychological

Keywords

Audiovisual Aids, Perioperative Period, Anxiety

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.

Detailed description

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.

Interventions

DEVICEZeiss, Cinema ProMED (audiovisual equipment)
DRUGMidazolam

Sponsors

Hospital for Special Surgery, New York
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Skin Conductance ResponseMeasured in 5 minute intervals, from holding area until PACU discharge.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.

Secondary

MeasureTime frameDescription
Systolic and Diastolic Blood PressureMeasured from preop to postopThe maximum change in postoperative systolic and diastolic blood pressure from holding area until PACU discharge.
Respiratory RateMeasured from preop to postopThe maxmimum change in postoperative respiratory rate from holding area until PACU discharge.
Number of Patients Who Requested Additional SedationIn the operating roomNumber of patients who requested additional sedative medication in the operating room.
Pain Numerical Rating Scale (NRS) LevelsHolding area, Postop (PACU, 30 minutes after arrival to PACU and POD1)Pain scores at rest will be collected from patients using the numerical rating scale (NRS), which asks patients to report their level of pain on a scale from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain. NRS levels in holding area, PACU until discharge from the PACU and one day after surgery, postop day 1.
Narcotic ConsumptionPreop until 24 hours after surgery (holding area until POD 1)Narcotic consumption intraop, postop and POD1
Beats Per Minute (BPM)Measured from preop to postopThe change in heart rate from holding area until PACU discharge.
Heidelberg Peri-anaesthetic QuestionnaireAt PACU upon spinal resolution.The questionnaire consists of 38 questions assessing perioperative satisfaction about five identified themes: trust and atmosphere; fear; discomfort; treatment by personnel; and information and waiting. The questions are rated on a 4-point Likert scale ranging from 0 (unimportant to me) to 3 (very important to me). Higher scores indicate higher levels of satisfaction. Patient satisfaction (Heidelberg Peri-Anaesthetic Questionnaire) in PACU upon spinal resolution.
Client Satisfaction Questionnaire (CSQ-8)PACU upon spinal resolutionThe client satisfaction questionnaire (CSQ-8) is a standardized satisfaction measure and was used to collect patient feedback on the audio visual devices. Response options differ, but all are on a 4-point scale. Scores range from 8 to 32, with higher values indicating higher satisfaction. Patient feedback (CSQ8) in PACU upon spinal resolution provider feedback (form sent to providers at end of surgery day)
Number of Providers That Were Satisfied With Their Experience With the Audio-visual AidsSent to providers at end of surgery.Anesthesia providers were asked to provide feedback on their experience with the audio-visual aids when the randomization was for the use of the device. This was collected upon surgery end.
Request of Sedation/Termination of AVAFrom consent until spinal resolution (avg 6 hs)Request of Sedation/Termination of AVA (After consent has been obtained until spinal resolution in the recovery room, average of 6 hours)
Number of Participants With ComplicationsIntraoperatively and in the recovery room, average of 3 hoursThe percentage of patients who experienced complications (headache, transient neurologic symptoms, nausea and vomiting, ...)
State-Trait Anxiety Inventory Questionnaire (STAI)holding area and PACUQuestionnaire to measure state anixety levels based on a 4-point likert scale and consists of 40 questions. The questionnaire measures two types of anxiety: state anxiety and trait anxiety. State anxiety relates to anxiety about an event, while trait anxiety in anxiety level as a personal characteristic. Scores can range from 20 to 80 and higher scores correlate with more anxiety.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. Midazolam Skin Conductance Monitor
13
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. Zeiss, Cinema ProMED (audiovisual equipment) Midazolam Skin Conductance Monitor
13
Total26

Baseline characteristics

CharacteristicSedation Only With Skin Conductance MonitorSedation & Audiovisual Aids With Skin Conductance MonitorTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
3 Participants0 Participants3 Participants
Age, Categorical
Between 18 and 65 years
10 Participants13 Participants23 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants1 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
11 Participants12 Participants23 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Black or African American
1 Participants0 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants1 Participants3 Participants
Race (NIH/OMB)
White
9 Participants11 Participants20 Participants
Region of Enrollment
United States
13 participants13 participants26 participants
Sex: Female, Male
Female
3 Participants0 Participants3 Participants
Sex: Female, Male
Male
10 Participants13 Participants23 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 130 / 13
other
Total, other adverse events
0 / 130 / 13
serious
Total, serious adverse events
0 / 130 / 13

Outcome results

Primary

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.

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

Population: We had planned to use the Med-Storm Stress detector to measure skin conductance throughout the procedure until discharge. However, due to repeated technical difficulties with the device and inconclusive data from an analysis of a small number of patients data collection was stopped. No data are presented here.

ArmMeasureValue (MEAN)
Sedation Only With Skin Conductance MonitorSkin Conductance ResponseNA skin conductance responses per second
Sedation & Audiovisual Aids With Skin Conductance MonitorSkin Conductance ResponseNA skin conductance responses per second
Secondary

Beats Per Minute (BPM)

The change in heart rate from holding area until PACU discharge.

Time frame: Measured from preop to postop

Population: Baseline has the heart rate number but analysis for intraop and postop is the change of the variable. Some patients were discharge earlier

ArmMeasureGroupValue (MEAN)Dispersion
Sedation Only With Skin Conductance MonitorBeats Per Minute (BPM)BPM Baseline71.7 Beats Per MinuteStandard Deviation 10.2
Sedation Only With Skin Conductance MonitorBeats Per Minute (BPM)BPM change Intraop17 Beats Per MinuteStandard Deviation 27
Sedation Only With Skin Conductance MonitorBeats Per Minute (BPM)BPM change Postop2 Beats Per MinuteStandard Deviation 10
Sedation & Audiovisual Aids With Skin Conductance MonitorBeats Per Minute (BPM)BPM Baseline66.8 Beats Per MinuteStandard Deviation 8.7
Sedation & Audiovisual Aids With Skin Conductance MonitorBeats Per Minute (BPM)BPM change Intraop17 Beats Per MinuteStandard Deviation 11
Sedation & Audiovisual Aids With Skin Conductance MonitorBeats Per Minute (BPM)BPM change Postop-6 Beats Per MinuteStandard Deviation 14
Secondary

Client Satisfaction Questionnaire (CSQ-8)

The client satisfaction questionnaire (CSQ-8) is a standardized satisfaction measure and was used to collect patient feedback on the audio visual devices. Response options differ, but all are on a 4-point scale. Scores range from 8 to 32, with higher values indicating higher satisfaction. Patient feedback (CSQ8) in PACU upon spinal resolution provider feedback (form sent to providers at end of surgery day)

Time frame: PACU upon spinal resolution

Population: This questionnaire was only administered to patients who used the audio-visual aids

ArmMeasureValue (MEDIAN)
Sedation & Audiovisual Aids With Skin Conductance MonitorClient Satisfaction Questionnaire (CSQ-8)31.5 scores on a scale
Secondary

Heidelberg Peri-anaesthetic Questionnaire

The questionnaire consists of 38 questions assessing perioperative satisfaction about five identified themes: trust and atmosphere; fear; discomfort; treatment by personnel; and information and waiting. The questions are rated on a 4-point Likert scale ranging from 0 (unimportant to me) to 3 (very important to me). Higher scores indicate higher levels of satisfaction. Patient satisfaction (Heidelberg Peri-Anaesthetic Questionnaire) in PACU upon spinal resolution.

Time frame: At PACU upon spinal resolution.

ArmMeasureValue (MEAN)Dispersion
Sedation Only With Skin Conductance MonitorHeidelberg Peri-anaesthetic Questionnaire97.2 score on a scaleStandard Deviation 14
Sedation & Audiovisual Aids With Skin Conductance MonitorHeidelberg Peri-anaesthetic Questionnaire98.9 score on a scaleStandard Deviation 9.5
Secondary

Narcotic Consumption

Narcotic consumption intraop, postop and POD1

Time frame: Preop until 24 hours after surgery (holding area until POD 1)

Population: POD1 - 13 patients from the AVA group were analyzed due to early discharge.

ArmMeasureGroupValue (MEAN)Dispersion
Sedation Only With Skin Conductance MonitorNarcotic ConsumptionOME mg Intraop2.3 oral morphine equivalents mgStandard Deviation 8.3
Sedation Only With Skin Conductance MonitorNarcotic ConsumptionOME mg Inpatient postop9.8 oral morphine equivalents mgStandard Deviation 6
Sedation Only With Skin Conductance MonitorNarcotic ConsumptionOME mg POD111.0 oral morphine equivalents mgStandard Deviation 9.9
Sedation & Audiovisual Aids With Skin Conductance MonitorNarcotic ConsumptionOME mg Intraop3.5 oral morphine equivalents mgStandard Deviation 12.5
Sedation & Audiovisual Aids With Skin Conductance MonitorNarcotic ConsumptionOME mg Inpatient postop10.8 oral morphine equivalents mgStandard Deviation 5
Sedation & Audiovisual Aids With Skin Conductance MonitorNarcotic ConsumptionOME mg POD111.5 oral morphine equivalents mgStandard Deviation 12.3
Secondary

Number of Participants With Complications

The percentage of patients who experienced complications (headache, transient neurologic symptoms, nausea and vomiting, ...)

Time frame: Intraoperatively and in the recovery room, average of 3 hours

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Sedation Only With Skin Conductance MonitorNumber of Participants With ComplicationsIncidence of Complication Intraop0 Participants
Sedation Only With Skin Conductance MonitorNumber of Participants With ComplicationsIncidence of Complication PACU0 Participants
Sedation & Audiovisual Aids With Skin Conductance MonitorNumber of Participants With ComplicationsIncidence of Complication Intraop0 Participants
Sedation & Audiovisual Aids With Skin Conductance MonitorNumber of Participants With ComplicationsIncidence of Complication PACU0 Participants
Secondary

Number of Patients Who Requested Additional Sedation

Number of patients who requested additional sedative medication in the operating room.

Time frame: In the operating room

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Sedation Only With Skin Conductance MonitorNumber of Patients Who Requested Additional Sedation5 Participants
Sedation & Audiovisual Aids With Skin Conductance MonitorNumber of Patients Who Requested Additional Sedation3 Participants
Secondary

Number of Providers That Were Satisfied With Their Experience With the Audio-visual Aids

Anesthesia providers were asked to provide feedback on their experience with the audio-visual aids when the randomization was for the use of the device. This was collected upon surgery end.

Time frame: Sent to providers at end of surgery.

Population: Providers were only asked to provide feedback on the equipment when used by patients in the audiovisual aid group upon surgery end.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Sedation & Audiovisual Aids With Skin Conductance MonitorNumber of Providers That Were Satisfied With Their Experience With the Audio-visual Aids07 Participants
Secondary

Pain Numerical Rating Scale (NRS) Levels

Pain scores at rest will be collected from patients using the numerical rating scale (NRS), which asks patients to report their level of pain on a scale from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain. NRS levels in holding area, PACU until discharge from the PACU and one day after surgery, postop day 1.

Time frame: Holding area, Postop (PACU, 30 minutes after arrival to PACU and POD1)

Population: Holding area, PACU arrival, 30 minutes after arrival to PACU and POD1.

ArmMeasureGroupValue (MEAN)Dispersion
Sedation Only With Skin Conductance MonitorPain Numerical Rating Scale (NRS) LevelsHolding area1.9 units on a scaleStandard Deviation 1.6
Sedation Only With Skin Conductance MonitorPain Numerical Rating Scale (NRS) LevelsPACU arrival0 units on a scaleStandard Deviation 0
Sedation Only With Skin Conductance MonitorPain Numerical Rating Scale (NRS) Levels30 minutes after arrival to PACU0.6 units on a scaleStandard Deviation 2.2
Sedation Only With Skin Conductance MonitorPain Numerical Rating Scale (NRS) LevelsPOD12.5 units on a scaleStandard Deviation 1.7
Sedation & Audiovisual Aids With Skin Conductance MonitorPain Numerical Rating Scale (NRS) LevelsPOD12.1 units on a scaleStandard Deviation 1.5
Sedation & Audiovisual Aids With Skin Conductance MonitorPain Numerical Rating Scale (NRS) LevelsHolding area2.2 units on a scaleStandard Deviation 1.4
Sedation & Audiovisual Aids With Skin Conductance MonitorPain Numerical Rating Scale (NRS) Levels30 minutes after arrival to PACU0 units on a scaleStandard Deviation 0
Sedation & Audiovisual Aids With Skin Conductance MonitorPain Numerical Rating Scale (NRS) LevelsPACU arrival0 units on a scaleStandard Deviation 0
Secondary

Request of Sedation/Termination of AVA

Request of Sedation/Termination of AVA (After consent has been obtained until spinal resolution in the recovery room, average of 6 hours)

Time frame: From consent until spinal resolution (avg 6 hs)

Population: This outcome is only providing findings for subjects that has sedation and audiovisual aids with skin conductance monitor. It does not pertain to subjects that had sedation without the AVA.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Sedation & Audiovisual Aids With Skin Conductance MonitorRequest of Sedation/Termination of AVANumber of Participants (AVA Randomization)13 Participants
Sedation & Audiovisual Aids With Skin Conductance MonitorRequest of Sedation/Termination of AVARequest of Sedation/Termination of AVA13 Participants
Secondary

Respiratory Rate

The maxmimum change in postoperative respiratory rate from holding area until PACU discharge.

Time frame: Measured from preop to postop

Population: Some data was not available for all participants due to equipment not working or due to early discharge

ArmMeasureGroupValue (MEAN)Dispersion
Sedation Only With Skin Conductance MonitorRespiratory RateRR Baseline17.2 breaths/minuteStandard Deviation 2.2
Sedation Only With Skin Conductance MonitorRespiratory RateRR change intraop5 breaths/minuteStandard Deviation 12
Sedation Only With Skin Conductance MonitorRespiratory RateRR change postop-1 breaths/minuteStandard Deviation 3
Sedation & Audiovisual Aids With Skin Conductance MonitorRespiratory RateRR change postop1 breaths/minuteStandard Deviation 5
Sedation & Audiovisual Aids With Skin Conductance MonitorRespiratory RateRR Baseline16.9 breaths/minuteStandard Deviation 1.7
Sedation & Audiovisual Aids With Skin Conductance MonitorRespiratory RateRR change intraop4 breaths/minuteStandard Deviation 4
Secondary

State-Trait Anxiety Inventory Questionnaire (STAI)

Questionnaire to measure state anixety levels based on a 4-point likert scale and consists of 40 questions. The questionnaire measures two types of anxiety: state anxiety and trait anxiety. State anxiety relates to anxiety about an event, while trait anxiety in anxiety level as a personal characteristic. Scores can range from 20 to 80 and higher scores correlate with more anxiety.

Time frame: holding area and PACU

Population: 4-point likert scale and consists of 40 questions

ArmMeasureGroupValue (MEAN)Dispersion
Sedation Only With Skin Conductance MonitorState-Trait Anxiety Inventory Questionnaire (STAI)STAI-State in holding area33.5 score on a scaleStandard Deviation 11.4
Sedation Only With Skin Conductance MonitorState-Trait Anxiety Inventory Questionnaire (STAI)STAI-Trait in holding area33.4 score on a scaleStandard Deviation 8.9
Sedation Only With Skin Conductance MonitorState-Trait Anxiety Inventory Questionnaire (STAI)STAI-State in PACU26.1 score on a scaleStandard Deviation 2.6
Sedation Only With Skin Conductance MonitorState-Trait Anxiety Inventory Questionnaire (STAI)STAI-Trait in PACU32.3 score on a scaleStandard Deviation 9.2
Sedation & Audiovisual Aids With Skin Conductance MonitorState-Trait Anxiety Inventory Questionnaire (STAI)STAI-Trait in PACU32.8 score on a scaleStandard Deviation 9.4
Sedation & Audiovisual Aids With Skin Conductance MonitorState-Trait Anxiety Inventory Questionnaire (STAI)STAI-State in holding area32.3 score on a scaleStandard Deviation 7
Sedation & Audiovisual Aids With Skin Conductance MonitorState-Trait Anxiety Inventory Questionnaire (STAI)STAI-State in PACU27.1 score on a scaleStandard Deviation 5.2
Sedation & Audiovisual Aids With Skin Conductance MonitorState-Trait Anxiety Inventory Questionnaire (STAI)STAI-Trait in holding area31.8 score on a scaleStandard Deviation 6
Secondary

Systolic and Diastolic Blood Pressure

The maximum change in postoperative systolic and diastolic blood pressure from holding area until PACU discharge.

Time frame: Measured from preop to postop

Population: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for baseline, intra op and post op was recorded.

ArmMeasureGroupValue (MEAN)Dispersion
Sedation Only With Skin Conductance MonitorSystolic and Diastolic Blood PressureDBP Baseline82.8 mmHgStandard Deviation 12.7
Sedation Only With Skin Conductance MonitorSystolic and Diastolic Blood PressureDBP change intraop3 mmHgStandard Deviation 8
Sedation Only With Skin Conductance MonitorSystolic and Diastolic Blood PressureDBP change postop-2 mmHgStandard Deviation 11
Sedation Only With Skin Conductance MonitorSystolic and Diastolic Blood PressureSBP Baseline135.3 mmHgStandard Deviation 14.5
Sedation Only With Skin Conductance MonitorSystolic and Diastolic Blood PressureSBP change intraop7 mmHgStandard Deviation 10
Sedation Only With Skin Conductance MonitorSystolic and Diastolic Blood PressureSBP change postop-8 mmHgStandard Deviation 13
Sedation & Audiovisual Aids With Skin Conductance MonitorSystolic and Diastolic Blood PressureSBP change intraop7 mmHgStandard Deviation 14
Sedation & Audiovisual Aids With Skin Conductance MonitorSystolic and Diastolic Blood PressureDBP Baseline79.6 mmHgStandard Deviation 9.5
Sedation & Audiovisual Aids With Skin Conductance MonitorSystolic and Diastolic Blood PressureSBP Baseline129.2 mmHgStandard Deviation 15.1
Sedation & Audiovisual Aids With Skin Conductance MonitorSystolic and Diastolic Blood PressureDBP change intraop2 mmHgStandard Deviation 7
Sedation & Audiovisual Aids With Skin Conductance MonitorSystolic and Diastolic Blood PressureSBP change postop-2 mmHgStandard Deviation 15
Sedation & Audiovisual Aids With Skin Conductance MonitorSystolic and Diastolic Blood PressureDBP change postop-4 mmHgStandard Deviation 6

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026