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NCT Number: NCT06144177

Induction in the Dark

This study will enroll children ages 2-6 who are undergoing an elective outpatient surgical procedure under general anesthesia. They will be randomized to one of the following groups and assessed for preoperative anxiety, mask acceptance, and behavioral changes in the following week.

1. darkened room and star projector with parental presence; 2. preoperative midazolam 0.5 mg/kg by mouth and parental presence; or 3. parental presence alone.

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Key information

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location status: Recruiting

Location contact

Haley Nitchie, MHA

CONTACT

[email protected]

843-792-1869

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dark with star projector

Other

When in the operating room prior to the start of induction, the room will be darkened, and a star projector that lights up the ceiling and walls will be turned on.

Preoperative midazolam

Drug

Midazolam by mouth preoperatively.

Parental presence

Other

A parent or guardian will accompany the child into the OR and be present for the start of induction.

Primary outcomes

  1. Mask acceptance

    Time frame: during induction evaluated up until the start of the scheduled surgery

    Mask acceptance during inhalational mask induction as measured by the mask acceptance scale (MAS). The MAS is scored on a scale from 1-4 by evaluating if the child is calm and accepting of the mask (4), slightly scared but easily calmed (3), has moderate fear of the mask and is not easily calmed (2), or cries, screams, or is terrified (1) during induction when using the inhalation mask. A higher score is better.

Secondary outcomes

  1. Perioperative anxiety

    Time frame: Measured preoperatively, then measured again during the entry to operating room.

    Perioperative anxiety will be measured using the modified Yale perioperative anxiety scale (mYpas) at two different time points; the first will be measured preoperatively in holding, and the other will be measured again during the entry to the operating room. The mYpas consists of 22 items, divided into five categories: activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parent. The evaluator will rate the subject in each category (he highest behavioral level observed in each of the five m-YPAS categories is the score for that category), then divide each item rating by the highest possible rating, add all of the produced values, multiply by 100, then divide by 2. The lower the score, the less anxiety the patient is exhibiting.

  2. Parental satisfaction of induction experience

    Time frame: evaluated after child's induction is complete up until the end of surgery

    After the induction period of anesthesia is over, the parent or guardian who accompanied the child to the operating room and was present for induction will complete a satisfaction survey. There are 6 questions rated from 1-5 (1 being strongly disagree, and 5 being strongly agree) asking how they felt about the induction experience. There is one question asking about how the parent felt about the child's acceptance of the mask during induction. This is rated from 1 (poor) to 4 (excellent). The scores given for each question are added up. Scores can range from 7-29. The higher the score, the better outcome and higher satisfaction.

  3. Post-Operative Emergency Delirium

    Time frame: from PACU arrival until discharge

    Once in the PACU, the patient will be evaluated for emergence delirium using the Pediatric Anesthesia Emergence Delirium (PAED) Scale. The evaluator will answer 3 questions about the patient's actions on a scale from 0 (extremely) to not at all (1), then an additional 2 questions about restlessness and inconsolable, scored from 0 (not at all) to 4 (extremely. The scores are added up. The total score can range from 0-20, and the lower the score, the better.

  4. Behavioral Changes

    Time frame: Day 1 Post-Op and Day 7 Post-Op, up to 30 days post-operatively

    At Day 1 Post-Op and again at Day 7 Post Op, a parent or guardian will answer a series of 27 questions that evaluate the child for behavioral changes occurring post-operatively by using the Post-Hospitalization Behavior Questionnaire (PHBQ). The rating scale for this assessment has 5 response options: (1) less than before (2), same as before (3), more than before (4), and much more than before (5). The answerers are added up with a possible range of 27-135. The lower the score, the less behavioral changes have occurred since the procedure.

  5. Time to PACU discharge

    Time frame: time in recovery, up to 30 days post-op

    The time in recovery will be measured from time in recovery starts, to time of discharge.

Study contacts

Contact information is provided by the study sponsor or research team.

Haley Nitchie, MHA

CONTACT

[email protected]

843-792-1869

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Induction in the Dark: a Prospective Randomized Control Trial for Perioperative Pediatric Anxiety

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 22, 2023
Registry last updated
Jun 22, 2026

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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