NCT04039269

Brief Summary

The study is designed to test the hypothesis that long term memory created by preoperative video information can reduce the incidence of post operative behavioral changes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2014

Completed
5.6 years until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

6.4 years

First QC Date

January 8, 2014

Last Update Submit

July 30, 2019

Conditions

Keywords

Post operative Behavioral ChangesPediatricLong term memoryvideo

Outcome Measures

Primary Outcomes (1)

  • Incidences of post operative behavioral changes

    Use PHBQ (post operative behavioral questionnaire) Postive for postoperative behavioral change: 10% change from baseline sum score

    up to3 months post operative period

Secondary Outcomes (3)

  • Incidences of Emergence agitation

    evaluate PAED scale in the first 5 minutes after patient arrive PACU

  • Parental's anxiety level at induction

    Evaluate 15 minutes before start anesthesia induction

  • Child's anxiety level at induction

    mYpas will be evaluated immediately after the patient arrives into the operating room

Study Arms (3)

Multiple (watch > 3 times)

ACTIVE COMPARATOR

Preoperative video information

Other: Preoperative video information

single (watch 1 time)

ACTIVE COMPARATOR

Preoperative video information

Other: Preoperative video information

conventional (do not watch)

NO INTERVENTION

Do not watch video

Interventions

Multiple (watch > 3 times)single (watch 1 time)

Eligibility Criteria

Age3 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • outpatient elective surgery
  • aged between 3-14 years
  • ASA physical status I-II

You may not qualify if:

  • mental retardation
  • patient's telephone contact not available
  • emergency case
  • having ICU admission plan postoperative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

RECRUITING

MeSH Terms

Conditions

BehaviorPsychomotor Agitation

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral Symptoms

Study Officials

  • Ngamjit Pattaravit, MD

    Prince of Songkla University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ngamjit Pattaravit, MD

CONTACT

Sasikaan Nimmaanrat, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Dr

Study Record Dates

First Submitted

January 8, 2014

First Posted

July 31, 2019

Study Start

December 1, 2013

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

July 31, 2019

Record last verified: 2019-07

Locations