Anesthesia InductionPhase 4NCT06144177
Induction in the Dark
A Phase 4 study testing Dark with star projector, Preoperative midazolam and Parental Presence in people with Anesthesia Induction, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Anesthesia Induction
- What is being tested?
- Dark with star projector, Preoperative midazolam and Parental Presence
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2024to 22 May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Haley Nitchie, MHA, 843-792-1869, nitchie@musc.edu
About this study
Official title: Induction in the Dark: a Prospective Randomized Control Trial for Perioperative Pediatric Anxiety
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.
- darkened room and star projector with parental presence;
- preoperative midazolam 0.5 mg/kg by mouth and parental presence; or
- parental presence alone.
- Conditions
- Anesthesia Induction
- Being tested
- Dark with star projector, Preoperative midazolam, Parental Presence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dark with star projectorOther
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 midazolamDrug
Midazolam by mouth preoperatively.
Parental PresenceOther
A parent or guardian will accompany the child into the OR and be present for the start of induction.
| Study group | Role | What they receive |
|---|---|---|
| Darkened room and star projector with parental presence | Active comparator | Subjects assigned to this arm, 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. They will also have a parent in the room with them during induction of anesthesia. Receives: Other: Dark with star projector; Other: Parental Presence |
| Preoperative midazolam 0.5 mg/kg po and parental presence | Active comparator | Subjects assigned to this arm will be given midazolam by mouth preoperatively, and will have a parent in the room with them during induction of anesthesia. Receives: Drug: Preoperative midazolam; Other: Parental Presence |
| Parental presence alone | Active comparator | Subjects assigned to this arm will have a parent in the room with them during induction of anesthesia. Receives: Other: Parental Presence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mask acceptance
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.
Measured: during induction evaluated up until the start of the scheduled surgery
Secondary outcomes (5)
Perioperative anxiety
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.
Measured: Measured preoperatively, then measured again during the entry to operating room.
Parental satisfaction of induction experience
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.
Measured: evaluated after child's induction is complete up until the end of surgery
Post-Operative Emergency Delirium
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.
Measured: from PACU arrival until discharge
Behavioral Changes
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.
Measured: Day 1 Post-Op and Day 7 Post-Op, up to 30 days post-operatively
Time to PACU discharge
The time in recovery will be measured from time in recovery starts, to time of discharge.
Measured: time in recovery, up to 30 days post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start16 Apr 2024
- Primary completion15 Apr 2027 (estimated)
- Study completion22 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia InductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalie Barnett, Medical University of South Carolina
- Investigators
- Natalie Barnett, M.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144177
- Sponsor's protocol ID
- Pro00132312
- Status last verified
- Jun 2026
- First submitted
- 16 Nov 2023
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction in the Dark: a Prospective Randomized Control Trial for Perioperative Pediatric Anxiety
- ClinicalTrials.gov ID
- NCT06144177
- Acronym / sponsor ID
- Pro00132312
- Conditions
- Anesthesia Induction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 22 May 2027 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- darkened room and star projector with parental presence;
- preoperative midazolam 0.5 mg/kg by mouth and parental presence; or
- parental presence alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Darkened room and star projector with parental presence | Active comparator | Other: Dark with star projector, Other: Parental PresenceSubjects assigned to this arm, 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. They will also have a parent in the room with them during induction of anesthesia. |
| Preoperative midazolam 0.5 mg/kg po and parental presence | Active comparator | Drug: Preoperative midazolam, Other: Parental PresenceSubjects assigned to this arm will be given midazolam by mouth preoperatively, and will have a parent in the room with them during induction of anesthesia. |
| Parental presence alone | Active comparator | Other: Parental PresenceSubjects assigned to this arm will have a parent in the room with them during induction of anesthesia. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dark with star projectorWhen 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. | Other | Darkened room and star projector with parental presence |
| Preoperative midazolamMidazolam by mouth preoperatively. | Drug | Preoperative midazolam 0.5 mg/kg po and parental presence |
| Parental PresenceA parent or guardian will accompany the child into the OR and be present for the start of induction. | Other | Darkened room and star projector with parental presence, Parental presence alone, Preoperative midazolam 0.5 mg/kg po and parental presence |
Primary outcome
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.
5 secondary outcomes
Perioperative anxiety
Time frame: Measured preoperatively, then measured again during the entry to operating room.
Parental satisfaction of induction experience
Time frame: evaluated after child's induction is complete up until the end of surgery
Post-Operative Emergency Delirium
Time frame: from PACU arrival until discharge
Behavioral Changes
Time frame: Day 1 Post-Op and Day 7 Post-Op, up to 30 days post-operatively
Time to PACU discharge
Time frame: time in recovery, up to 30 days post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natalie Barnett, M.D. principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dark with star projector, Preoperative midazolam and Parental Presence in people with Anesthesia Induction, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haley Nitchie, MHA (843-792-1869, nitchie@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mask acceptance (time frame: during induction evaluated up until the start of the scheduled surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.