AnxietyNCT05368961

Comparison of Usual Care and Distraction (Tablet) in Children 3-5 Years Old

A study testing Distraction in people with Anxiety, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Randomized control trial comparing usual care and distraction (tablet) on anxiety, emergence delirium, sedation/agitation, and vomiting in children 3-5 years old Read more about this study

Who is it for?: Ages 3 to 5 yearsHealthy volunteers can take part
Conditions the study is for: Anxiety
What is being tested?: Distraction
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 137 participants
Where: 1 siteUnited States
Study dates: 7 Apr 2017to 8 Mar 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 3 to 5 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

3-5 year old children
Scheduled for elective surgery
American Society of Anesthesiologists physical status classification system: I - II

Who cannot join

Children younger than 3 or older than 6
Allergy to midazolam
Cognitive or developmental delays
American Society of Anesthesiologists physical status classification system: III - VI
Anesthesia provider determines child is not eligible
Children that are transferred to ICU after surgery

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic
Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: Comparison of Midazolam (Versed) and Distraction on Anxiety, Emergence Delirium, Sedation/Agitation, and Vomiting in Pre-operative Patients Ages 3 to 5.

Randomized control trial comparing usual care and distraction (tablet) on anxiety, emergence delirium, sedation/agitation, and vomiting in children 3-5 years old

Read the detailed description

Two group RCT comparing usual care (midazolam) and distraction (tablet) on preoperative anxiety, emergence delirium, sedation/agitation, and vomiting in preschool children 3-5 years old.

Conditions: Anxiety
Being tested: Distraction, Usual care
Medical subject headings: Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DistractionBehavioural
Distraction (interactive tablet)
Usual careOther
Also called Anxiolytic per anesthesia
Anxiolytic ordered by anesthesiologist is usual care

Study groups in NCT05368961
Study group	Role	What they receive
Usual care	Active comparator	Usual care (midazolam) is administered pre-operatively Receives: Other: Usual care
Distraction	Experimental	Distraction (interactive tablet) is given to children pre-operatively Receives: Behavioral: Distraction

What is being measured

The primary outcome is the main question the study is designed to answer.

mYPAS Anxiety Score, Patients With Scores of 30 or More Indicated "Anxiety"
Pre-operative anxiety measured by the modified Yale Preoperative Anxiety Scale (mYPAS); scores range 23-100 with higher scores indicating greater levels of anxiety.
A categorical variable was created using a cut-off score of 30 or more to indicate "anxiety" and scores of less than 30 indicated "no anxiety".
Measured: Pre-induction of mask anesthesia in the operating room

Secondary outcomes (5)

Sedation/Agitation
Sedation/agitation was assessed using the Richmond Agitation Sedation Scale (RASS)
The RASS scale is a 10-item observational tool. Scores on RASS range from negative 5 (unarousable) to positive 4 (combative/violent). For this study, we categorized the RASS scores as agitated, calm, or sedated. Scores of 2 or higher indicated "agitation", scores of +1 to -1 were "calm", and scores of -2 or lower indicated "sedation".
Measured: Pre-induction of mask anesthesia in the operating room
Number of Participants Experiencing Emergence Delirium
Postoperatively pediatric patients were assessed for emergence delirium using the Pediatric Anesthesia Emergence Delirium (PAED) tool.
The scale uses a 5-point Likert scale with total scores ranging from 0 - 20. This study used a score of 12-20 to indicate the presence of "emergence delirium."
Measured: After surgery when patient woke up in the post anesthesia care unit (recovery room)
Sedation/Agitation
Sedation/agitation was assessed using the Richmond Agitation Sedation Scale (RASS)
The RASS scale is a 10-item observational tool. Scores on RASS range from negative 5 (unarousable) to positive 4 (combative/violent). For this study, we categorized the RASS scores as agitated, calm, or sedated. Scores of 2 or higher indicated "agitation", scores of +1 to -1 were "calm", and scores of -2 or lower indicated "sedation".
Measured: After surgery at the time of admission to post anesthesia care unit (recovery room)
Length of Stay (Minutes)
Length of stay (total minutes) = time patient admitted to post anesthesia care unit (recovery room) until discharged from post anesthesia care unit.
Measured: Post operative until discharged from post anesthesia care unit (recovery room)
The Number of Patients Experiencing Postoperative Vomiting
The number of participants that vomited in the post-anesthesia care unit (from the time they were admitted until they were discharged).
Measured: After surgery in the post anesthesia care unit from admission to discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Apr 20178 Mar 2019

First posted10 May 2022
Study start7 Apr 2017
Primary completion8 Mar 2019
Study completion8 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for AnxietyStudies of the same condition, open and under way.
More trials run by The Cleveland ClinicThe sponsor's other registered studies.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Group 1: usual care Group 2: distraction
Masking: None (open label)
Enrolment: 137 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05368961
Sponsor's protocol ID: 16-511
Status last verified: Mar 2024
First submitted: 28 Apr 2022
Last updated: 1 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Seiden SC, McMullan S, Sequera-Ramos L, De Oliveira GS Jr, Roth A, Rosenblatt A, Jesdale BM, Suresh S. Tablet-based Interactive Distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: a noninferiority randomized trial. Paediatr Anaesth. 2014 Dec;24(12):1217-23. doi: 10.1111/pan.12475. Epub 2014 Jul 17.
PubMed 25040433
Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.
PubMed 15114210
Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004 Dec;99(6):1648-1654. doi: 10.1213/01.ANE.0000136471.36680.97.
PubMed 15562048

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Anxiety trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Midazolam (Versed) and Distraction on Anxiety, Emergence Delirium, Sedation/Agitation, and Vomiting in Pre-operative Patients Ages 3 to 5.
ClinicalTrials.gov ID: NCT05368961
Acronym / sponsor ID: 16-511
Conditions: Anxiety
Study type: Interventional
Recruitment status: Completed
Enrolment: 137 participants (actual)
Lead sponsor: The Cleveland ClinicUniversity, hospital or other
Study start: 7 Apr 2017 (actual)
Primary completion: 8 Mar 2019 (actual)
Study completion: 8 Mar 2019 (actual)
First posted: 10 May 2022 (actual)
Results: Posted 1 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Randomized control trial comparing usual care and distraction (tablet) on anxiety, emergence delirium, sedation/agitation, and vomiting in children 3-5 years old

Detailed description

Two group RCT comparing usual care (midazolam) and distraction (tablet) on preoperative anxiety, emergence delirium, sedation/agitation, and vomiting in preschool children 3-5 years old.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Group 1: usual care Group 2: distraction

Arm	Type	Receives
Usual care	Active comparator	Other: Usual careUsual care (midazolam) is administered pre-operatively
Distraction	Experimental	Behavioral: DistractionDistraction (interactive tablet) is given to children pre-operatively

Who may qualify

Ages: 3 to 5 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

3-5 year old children
Scheduled for elective surgery
American Society of Anesthesiologists physical status classification system: I - II

Key exclusion criteria (6 listed)

Children younger than 3 or older than 6
Allergy to midazolam
Cognitive or developmental delays
American Society of Anesthesiologists physical status classification system: III - VI
Anesthesia provider determines child is not eligible

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
DistractionDistraction (interactive tablet)	Behavioural	Distraction
Usual careAlso: Anxiolytic per anesthesiaAnxiolytic ordered by anesthesiologist is usual care	Other	Usual care

Primary outcome

mYPAS Anxiety Score, Patients With Scores of 30 or More Indicated "Anxiety"
Time frame: Pre-induction of mask anesthesia in the operating room
Pre-operative anxiety measured by the modified Yale Preoperative Anxiety Scale (mYPAS); scores range 23-100 with higher scores indicating greater levels of anxiety. A categorical variable was created using a cut-off score of 30 or more to indicate "anxiety" and scores of less than 30 indicated "no anxiety".

5 secondary outcomes

Sedation/Agitation
Time frame: Pre-induction of mask anesthesia in the operating room
Number of Participants Experiencing Emergence Delirium
Time frame: After surgery when patient woke up in the post anesthesia care unit (recovery room)
Sedation/Agitation
Time frame: After surgery at the time of admission to post anesthesia care unit (recovery room)
Length of Stay (Minutes)
Time frame: Post operative until discharged from post anesthesia care unit (recovery room)
The Number of Patients Experiencing Postoperative Vomiting
Time frame: After surgery in the post anesthesia care unit from admission to discharge

Results and safety

Results posted to the registry on 1 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	74	47
Distraction	63	52

Primary outcome: mYPAS Anxiety Score, Patients With Scores of 30 or More Indicated "Anxiety"

Time frame: Pre-induction of mask anesthesia in the operating room. Count of participants. Unit: Participants

Measure	Usual Care n = 47	Distraction n = 52
Value	20	22

Usual Care vs Distraction: p = 0.44, Wilcoxon (Mann-Whitney)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Time in study = time they received the intervention (control or experimental) until discharged from post anesthesia care unit. Each participant was in the study from 2-6 hours. Operating room times varied by surgical procedure.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	0 of 47 (0%)	0 of 47 (0%)	0 of 47
Distraction	0 of 52 (0%)	0 of 52 (0%)	0 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25040433Seiden SC, McMullan S, Sequera-Ramos L, De Oliveira GS Jr, Roth A, Rosenblatt A, Jesdale BM, Suresh S. Tablet-based Interactive Distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: a noninferiority randomized trial. Paediatr Anaesth. 2014 Dec;24(12):1217-23. doi: 10.1111/pan.12475. Epub 2014 Jul 17.
Background: PubMed 15114210Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.
Background: PubMed 15562048Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004 Dec;99(6):1648-1654. doi: 10.1213/01.ANE.0000136471.36680.97.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Nancy M Albert, PhD study director

The Cleveland Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Distraction in people with Anxiety, run by The Cleveland Clinic 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 1 Apr 2024. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mYPAS Anxiety Score, Patients With Scores of 30 or More Indicated "Anxiety" (time frame: Pre-induction of mask anesthesia in the operating room). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05368961, which also lists 3 linked publications.

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 1 Apr 2024.