Adults 3 to 5, any sex, with Anxiety. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
mYPAS Anxiety Score, Patients With Scores of 30 or More Indicated "Anxiety"Primary· Pre-induction of mask anesthesia in the operating room
Pre-operative anxiety measured by the modified Yale Preoperative Anxiety Scale (mYPAS); scores range 23-100 with higher scores indicating greater levels of anxiety.
A categorical variable was created using a cut-off score of 30 or more to indicate "anxiety" and scores of less than 30 indicated "no anxiety".
Group
Value
95% CI
Usual Care
20
Distraction
22
Sedation/AgitationSecondary· Pre-induction of mask anesthesia in the operating room
Sedation/agitation was assessed using the Richmond Agitation Sedation Scale (RASS)
The RASS scale is a 10-item observational tool. Scores on RASS range from negative 5 (unarousable) to positive 4 (combative/violent). For this study, we categorized the RASS scores as agitated, calm, or sedated. Scores of 2 or higher indicated "agitation", scores of +1 to -1 were "calm", and scores of -2 or lower indicated "sedation".
Sedated
Group
Value
95% CI
Usual Care
1
Distraction
0
Calm
Group
Value
95% CI
Usual Care
42
Distraction
45
Agitated
Group
Value
95% CI
Usual Care
4
Distraction
7
Number of Participants Experiencing Emergence DeliriumSecondary· After surgery when patient woke up in the post anesthesia care unit (recovery room)
Postoperatively pediatric patients were assessed for emergence delirium using the Pediatric Anesthesia Emergence Delirium (PAED) tool.
The scale uses a 5-point Likert scale with total scores ranging from 0 - 20. This study used a score of 12-20 to indicate the presence of "emergence delirium."
Group
Value
95% CI
Usual Care
7
Distraction
8
Sedation/AgitationSecondary· After surgery at the time of admission to post anesthesia care unit (recovery room)
Sedation/agitation was assessed using the Richmond Agitation Sedation Scale (RASS)
The RASS scale is a 10-item observational tool. Scores on RASS range from negative 5 (unarousable) to positive 4 (combative/violent). For this study, we categorized the RASS scores as agitated, calm, or sedated. Scores of 2 or higher indicated "agitation", scores of +1 to -1 were "calm", and scores of -2 or lower indicated "sedation".
Sedated
Group
Value
95% CI
Usual Care
45
Distraction
48
Calm
Group
Value
95% CI
Usual Care
0
Distraction
3
Agitated
Group
Value
95% CI
Usual Care
2
Distraction
1
Length of Stay (Minutes)Secondary· Post operative until discharged from post anesthesia care unit (recovery room)
Length of stay (total minutes) = time patient admitted to post anesthesia care unit (recovery room) until discharged from post anesthesia care unit.
Group
Value
95% CI
Usual Care
88.0
78.0 – 101.0
Distraction
75.5
59.5 – 98.0
The Number of Patients Experiencing Postoperative VomitingSecondary· After surgery in the post anesthesia care unit from admission to discharge
The number of participants that vomited in the post-anesthesia care unit (from the time they were admitted until they were discharged).
Group
Value
95% CI
Usual Care
1
Distraction
2
Sponsor's own description
Randomized control trial comparing usual care and distraction (tablet) on anxiety, emergence delirium, sedation/agitation, and vomiting in children 3-5 years old
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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NCT05511857 — Could Self-distancing Alter the Perception of Experimental Pain?
· NA
· unknown
NCT03540589 — Distraction and Vibration for Minimizing Pain During Childhood Vaccination
· NA
· completed
NCT03647683 — Self-Compassion and Acute Pain
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Trials by the same sponsor.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The Cleveland Clinic
Last refreshed: 1 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05368961.