NCT04049201

Brief Summary

preoperative anxiety is an undesirable outcome in pediatric surgical patients.It can lead to behavioral trouble such as enuresis, apathy and sleep disorders. to prevent this anxiety,many tools can be used for premedication like pharmacological:Midazolam, clonidine, hydroxysine or non pharmacological tools such as parental presence,hypnosis and interactive tablet. the purpose of the study is to compare the effect of interactive tablet to oral midazolam.on preoperative anxiety in children prior to elective surgery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 8, 2019

Completed
Last Updated

August 8, 2019

Status Verified

May 1, 2019

Enrollment Period

1 year

First QC Date

March 18, 2019

Last Update Submit

August 7, 2019

Conditions

Anxiety

Outcome Measures

Primary Outcomes (3)

  • Preoperative anxiety

    preoperative anxiety will be measured by the modified Yale Perioperative Anxiety Scale (MYPAS)at different time prior to elective surgery .the averaged score range from 24.9: no anxiety to 100 very anxious

    20 minutes after tablet was given

  • Preoperative anxiety

    preoperative anxiety will be measured by the modified Yale Perioperative Anxiety Scale(MYPAS)at different time prior to elective surgery .the averaged score ranges from 24.9 no anxiety to 100 very anxious

    25 minutes after tablet was given

  • Preoperative anxiety

    preoperative anxiety will be measured by the modified Yale Perioperative Anxiety Scale(MYPAS)at different time prior to elective surgery.the averaged score range from 24.9 no anxiety to 100 very anxious

    30 minutes after tablet was given

Secondary Outcomes (3)

  • the acceptance of Facial mask

    30 minutes after tablet was given

  • post operative agitation

    10 to 15 minutes after wakeup of anesthesia

  • the parental satisfaction

    1 hour after the wake up of anesthesia

Study Arms (2)

Group tablet

EXPERIMENTAL

group T will receive interactive Tablet containing many cartoon's videos 20 minutes before parental separation until the anesthesia induction

Procedure: elective surgeryDevice: Interactive Tablet

Group Midazolam

ACTIVE COMPARATOR

group Midazolam will receive oral midazolam 0.5 mg/kg (max 20 mg) 20 minutes before the parental separation

Procedure: elective surgeryDrug: Midazolam

Interventions

elective surgeryPROCEDURE

investigators will compare the effect of interactive tablet on preoperative anxiety in children to the effect ofMidazolam in elective surgery

Also known as: we will study the acceptance of the facial mask,the post operative delirium and the parents satisfaction
Group MidazolamGroup tablet
MidazolamDRUG

Oral Midazolam

Group Midazolam
Interactive TabletDEVICE

interactive Tablet containing many cartoon's videos

Group tablet

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years old children
  • elective surgery
  • ASA PS I/II

You may not qualify if:

  • Parental refusal
  • Emergency procedure
  • Behavioral or psychiatric disorders
  • allergy or hypersensitivity to midazolam

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital d'Enfants Bechir Hamza

Tunis, 1029, Tunisia

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Elective Surgical ProceduresMidazolam

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical Professor

Study Record Dates

First Submitted

March 18, 2019

First Posted

August 8, 2019

Study Start

May 4, 2018

Primary Completion

May 19, 2019

Study Completion

May 19, 2019

Last Updated

August 8, 2019

Record last verified: 2019-05

Locations

TU(1)