Long Term Memory Preoperative Preparation Reduce Post Operative Behavioral Change

July 30, 2019 updated by: Ngamjit Pattaravit, Prince of Songkla University

Could Long Term Memory Created by Preoperative Video Information Reduce Post Operative Behavioral Change?

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

192

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Songkhla
      • Hat-Yai, Songkhla, Thailand, 90110
        • Recruiting
        • Faculty of Medicine, Prince of Songkla University
        • Contact:
        • Sub-Investigator:
          • Orarat Karnjanawanichkul, MD
        • Sub-Investigator:
          • Chanattee Kitsiripan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Multiple (watch > 3 times)
Preoperative video information
Other: Preoperative video information
Active Comparator: single (watch 1 time)
Preoperative video information
Other: Preoperative video information
No Intervention: conventional (do not watch)
Do not watch video

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidences of post operative behavioral changes
Time Frame: up to3 months post operative period
Use PHBQ (post operative behavioral questionnaire) Postive for postoperative behavioral change: 10% change from baseline sum score
up to3 months post operative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidences of Emergence agitation
Time Frame: evaluate PAED scale in the first 5 minutes after patient arrive PACU
PAED scale, PAED scale > 10 will be classified as positive for emergence agitation
evaluate PAED scale in the first 5 minutes after patient arrive PACU
Parental's anxiety level at induction
Time Frame: Evaluate 15 minutes before start anesthesia induction

STATE trait anxiety test:

10% change from baseline sum score will be classify as significant change
Evaluate 15 minutes before start anesthesia induction
Child's anxiety level at induction
Time Frame: mYpas will be evaluated immediately after the patient arrives into the operating room
mYpas scale: 10% change from baseline sum score will be classify as significant change
mYpas will be evaluated immediately after the patient arrives into the operating room

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prince of Songkla University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2013

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

January 8, 2014

First Submitted That Met QC Criteria

July 30, 2019

First Posted (Actual)

July 31, 2019

Study Record Updates

Last Update Posted (Actual)

July 31, 2019

Last Update Submitted That Met QC Criteria

July 30, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSUEA2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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