Using different methods to help children feel less anxious during anesthesia induction
Induction in the Dark: a Prospective Randomized Control Trial for Perioperative Pediatric Anxiety
PHASE4 · Medical University of South Carolina · NCT06144177
This study tests different ways to help young children feel less anxious when they are getting ready for surgery with anesthesia.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 2 Years to 6 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina (other) |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT06144177 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 2 to 6 years who are undergoing elective outpatient surgical procedures under general anesthesia.
Not a fit: Patients with a history of previous surgery, severe developmental delays, or significant preoperative anxiety may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for reducing anxiety in young children undergoing anesthesia, enhancing their overall surgical experience.
How similar studies have performed: While there have been studies on anxiety reduction in pediatric anesthesia, this specific approach combining environmental factors and medication is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Charleston, South Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anesthesia Induction