Audiovisual Distraction
Devicewatching a movie using video glasses and headphones
Other names: Audiovisual Aids, Zeiss Cinemizer OLED Glasses, HappyMed Video Glasses
NCT Number: NCT03020914
Patients will be randomly assigned to either one of two groups:
1. Standard of care sedation 2. Audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library
Monitoring and anesthesia regimen will be standardized
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Before consent patients will be thoroughly informed about possible risks or benefits and about their possibilities to end the study at any time point or to ask for additional sedation if they feel uncomfortable or anxious. After they consent, they will be randomly assigned to either receive standard sedation (Group 1) or audiovisual distraction (Group 2). Each group will consist of 30 patients. The randomization schedule will be created by a member of the Healthcare Research Institute using SAS software, who is not otherwise involved in the trial.
The intraoperative anesthesia regimen will be standardized:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
watching a movie using video glasses and headphones
Other names: Audiovisual Aids, Zeiss Cinemizer OLED Glasses, HappyMed Video Glasses
Time frame: start of anesthesia until 30 minutes after recovery room admission (ca. 3 hours)
number of desaturation events (SpO2< 90% for ≥ 10 sec) measured during this time frame
Time frame: start of anesthesia until 30 minutes after recovery room admission (ca. 3 hours)
each airway intervention (defined as one of the following: jaw thrust, oropharyngeal airway, nasopharyngeal airway, mask ventilation, larynx mask or intubation) that is implemented during this time frame will be observed and documented by research staff, if it occurs.
Time frame: intraoperative
Patient request for additional sedation
Time frame: 10 minutes before recovery room discharge
Patient satisfaction at recovery room discharge as measured by the Heidelberg perianesthetic questionnaire, which assesses patients' peri-anaesthetic satisfaction on a four-point Likert scale ranging from 0 (unimportant to me) to 3 (very important to me). Scores for each question are summed for a final score, with higher total score signifying higher satisfaction and lower total score signifying lower satisfaction. The score scale has a minimum value of 0 and a maximum value of 114 (based off 3 as the highest response score for 38 individual questions).
Time frame: 4 times: preoperative, intraoperative, at time of recovery room admission, 10 minutes before recovery room discharge
Alertness levels measured using the Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S), which rates alertness on a scale of 0-5, with higher ratings representing increased alertness (e.g. '5 - Responds readily to name spoken in normal tone'). Results reflect a median score of ratings collected at 4 time points.
Hospital for Special Surgery, New York
Other
Effects of Audiovisual Distraction Versus Standard Sedation on Desaturation and Airway Intervention in OSA-patients Undergoing Total Knee Arthroplasty Under Neuraxial Anesthesia
Acronym: AVD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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