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Long Term Memory Preoperative Preparation Reduce Post Operative Behavioral Change

NCT ID: NCT04039269

Last Updated: 2019-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2020-05-31

Brief Summary

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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.

Detailed Description

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Emergence agitation (EA) and Post operative behavioral change (PHC) are unpleasant experiences occurred in children after general anesthesia (GA). Previous study reported that the patient who had marked EA tended to have new-onset of postoperative maladaptive behavioral changes.Both pharmacologic and non pharmacologic interventions such as preoperative video information, hand held video games were used to reduce preoperative anxiety, EA and Post operative behavioral changes. In term of memory creation, short term memory (STM) was created. Later that the formation of memory trace requires time, and that this trace remains fragile until the long term memory formation process has been completed. In this study, the investigators hypothetize that long term memory created by preoperative video information can reduce the incidence of post operative behavioral changes.

Conditions

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Behavior Agitation

Keywords

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Post operative Behavioral Changes Pediatric Long term memory video

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Multiple (watch > 3 times)

Preoperative video information

Group Type ACTIVE_COMPARATOR

Preoperative video information

Intervention Type OTHER

single (watch 1 time)

Preoperative video information

Group Type ACTIVE_COMPARATOR

Preoperative video information

Intervention Type OTHER

conventional (do not watch)

Do not watch video

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Preoperative video information

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* mental retardation
* patient's telephone contact not available
* emergency case
* having ICU admission plan postoperative
Minimum Eligible Age

3 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

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Ngamjit Pattaravit

Assistant Professor, Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ngamjit Pattaravit, MD

Role: PRINCIPAL_INVESTIGATOR

Prince of Songkla University

Locations

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Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Ngamjit Pattaravit, MD

Role: CONTACT

Phone: +66897001350

Email: [email protected]

Sasikaan Nimmaanrat, MD

Role: CONTACT

Phone: +6674451651

Email: [email protected]

Facility Contacts

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Thavat Chanchayanon, MD

Role: primary

Other Identifiers

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PSUEA2

Identifier Type: -

Identifier Source: org_study_id