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Stress, PsychologicalNCT02506673

Audiovisual Aid Pilot Study

A study testing Zeiss, Cinema ProMED (audiovisual equipment), Midazolam and Skin Conductance Monitor in people with Stress, Psychological, run by Hospital for Special Surgery, New York at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stress, Psychological
What is being tested?
Zeiss, Cinema ProMED (audiovisual equipment), Midazolam and Skin Conductance Monitor
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
14 Jan 2016to Jul 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hospital for Special Surgery (HSS)

    New York, New York, 10021

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Zeiss, Cinema ProMED (audiovisual equipment), Midazolam, Skin Conductance Monitor
Keywords
Audiovisual Aids, Perioperative Period, Anxiety
Medical subject headings
Stress, Psychological, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zeiss, Cinema ProMED (audiovisual equipment)Device

  • MidazolamDrug

  • Skin Conductance MonitorDevice

Study groups in NCT02506673
Study groupRoleWhat they receive
Sedation only with skin conductance monitorActive comparatorPatients 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.
Receives: Drug: Midazolam; Device: Skin Conductance Monitor
Sedation & audiovisual aids with skin conductance monitorExperimentalPrior 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.
Receives: Device: Zeiss, Cinema ProMED (audiovisual equipment); Drug: Midazolam; Device: Skin Conductance Monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (12)

  1. Beats Per Minute (BPM)

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

    Measured: Measured from preop to postop

  2. Systolic and Diastolic Blood Pressure

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

    Measured: Measured from preop to postop

  3. Respiratory Rate

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

    Measured: Measured from preop to postop

  4. Number of Patients Who Requested Additional Sedation

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

    Measured: In the operating room

  5. 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.

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

  6. Narcotic Consumption

    Narcotic consumption "intraop", "postop" and "POD1"

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

  7. 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.

    Measured: holding area and PACU

  8. 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.

    Measured: At PACU upon spinal resolution.

  9. 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)

    Measured: PACU upon spinal resolution

  10. 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.

    Measured: Sent to providers at end of surgery.

  11. 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)

    Measured: From consent until spinal resolution (avg 6 hs)

  12. Number of Participants With Complications

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2015 (estimated)
  2. Study start14 Jan 2016
  3. Primary completionMay 2017
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02506673
Sponsor's protocol ID
2014-394
Status last verified
Apr 2024
First submitted
2 Jul 2015
Last updated
27 Dec 2024
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Zeiss, Cinema ProMED (audiovisual equipment), Midazolam and Skin Conductance Monitor in people with Stress, Psychological, run by Hospital for Special Surgery, New York at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Skin Conductance Response (time frame: Measured in 5 minute intervals, from holding area until PACU discharge.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02506673.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.

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