Using different methods to help children feel less anxious during anesthesia induction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study enrolls children aged 2 to 6 who are scheduled for elective outpatient surgeries requiring general anesthesia. Participants will be randomly assigned to one of three groups: a darkened room with a star projector and parental presence, preoperative midazolam with parental presence, or parental presence alone. The study aims to assess preoperative anxiety levels, mask acceptance, and behavioral changes in the week following the procedure. The goal is to determine which method is most effective in reducing anxiety during anesthesia induction.

Why it matters

Who can join: the full rules

Inclusion Criteria

* 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

Exclusion Criteria

* 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

Where it's running

• Medical University of South Carolina
  Charleston, South Carolina, United States Recruiting

Study contacts

• Principal investigator: Natalie Barnett, M.D. — Medical University of South Carolina
• Study coordinator: Haley Nitchie, MHA
• Email: nitchie@musc.edu
• Phone: 843-792-1869

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.