Audiovisual Aid Pilot Study
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | January 14, 2016 |
| End Date: | July 2017 |
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.
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.
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.
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.
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
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