Audiovisual Aid Pilot Study

Stress, Psychological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02506673
• Other study ID #: 2014-394
• Status: Completed
• Phase: N/A
• Start date: January 14, 2016
• Est. completion date: July 2017

Study information

• Verified date: April 2024
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stress, Psychological

Intervention

Device:
• Zeiss, Cinema ProMED (audiovisual equipment)

Drug:
• Midazolam

Device:
• Skin Conductance Monitor

Locations

Country	Name	City	State
United States	Hospital for Special Surgery (HSS)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Measured in 5 minute intervals, from holding area until PACU discharge.
Secondary	Beats Per Minute (BPM)	The change in heart rate from holding area until PACU discharge.	Measured from preop to postop
Secondary	Systolic and Diastolic Blood Pressure	The maximum change in postoperative systolic and diastolic blood pressure from holding area until PACU discharge.	Measured from preop to postop
Secondary	Respiratory Rate	The maxmimum change in postoperative respiratory rate from holding area until PACU discharge.	Measured from preop to postop
Secondary	Number of Patients Who Requested Additional Sedation	Number of patients who requested additional sedative medication in the operating room.	In the operating room
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.	Holding area, Postop (PACU, 30 minutes after arrival to PACU and POD1)
Secondary	Narcotic Consumption	Narcotic consumption "intraop", "postop" and "POD1"	Preop until 24 hours after surgery (holding area until POD 1)
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.	holding area and PACU
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.	At PACU upon spinal resolution.
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)	PACU upon spinal resolution
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.	Sent to providers at end of surgery.
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)	From consent until spinal resolution (avg 6 hs)
Secondary	Number of Participants With Complications	The percentage of patients who experienced complications (headache, transient neurologic symptoms, nausea and vomiting, ...)	Intraoperatively and in the recovery room, average of 3 hours