Actively Recruiting
Induction in the Dark: a Prospective Randomized Control Trial for Perioperative Pediatric Anxiety
Led by Medical University of South Carolina · Updated on 2025-07-08
240
Participants Needed
1
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying children aged 2 to 6 undergoing elective outpatient surgery with general anesthesia to compare ways to reduce anxiety before anesthesia induction. The trial evaluates how different approaches affect preoperative anxiety, mask acceptance during anesthesia, and behavioral changes during the week after surgery. This is a randomized study led by the Medical University of South Carolina. Participants are randomly assigned to one of three groups: a darkened room with a star projector plus parental presence; preoperative oral midazolam combined with parental presence; or parental presence alone during anesthesia induction. Each group experiences their assigned intervention during the start of anesthesia in the operating room. During the study, children are assessed for mask acceptance at induction, anxiety before surgery and upon entering the operating room, parental satisfaction with the induction experience, emergency delirium after surgery, behavioral changes up to 30 days post-op, and recovery time until discharge from the post-anesthesia care unit. The total study duration includes assessments from preoperative to 30 days after surgery, with no blinding or placebo use.
CONDITIONS
Brief Title
Induction in the Dark
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2 to 6 years old
- American Society of Anesthesiologists physical status I-II
- Outpatient elective surgical procedures
- Undergoing general anesthesia
- Parent or guardian willing to be present during induction
You will not qualify if you...
- History of previous surgery
- Fear of the dark
- Contraindication to inhalational mask induction of general anesthesia such as allergy to inhalation medication, NPO violation, active nausea or vomiting, severe GERD, etc.
- Severe developmental delay
- Severe obvious, preoperative anxiety
- Patients currently using psychiatric medications
- Non-English speaking
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants receive assigned interventions during the induction of anesthesia, which may include a darkened room with a star projector and parental presence, preoperative midazolam with parental presence, or parental presence alone.
1 visit during surgery
Duration - Up to 30 days post-operatively
Participants are monitored for post-operative recovery including emergency delirium, behavioral changes, and time to discharge from post-anesthesia care.
2 visits (Day 1 and Day 7 post-op) plus recovery assessments until discharge
Trial Site Locations
Total: 1 location
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
H
Haley Nitchie, MHA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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