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Long Term Memory Preoperative Preparation Reduce Post Operative Behavioral Change

Primary Purpose

Behavior, Agitation

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Preoperative video information
Sponsored by
Prince of Songkla University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Behavior focused on measuring Post operative Behavioral Changes, Pediatric, Long term memory, video

Eligibility Criteria

3 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine, Prince of Songkla UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Multiple (watch > 3 times)

single (watch 1 time)

conventional (do not watch)

Arm Description

Preoperative video information

Preoperative video information

Do not watch video

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidences of Emergence agitation
PAED scale, PAED scale > 10 will be classified as positive for emergence agitation
Parental's anxiety level at induction
STATE trait anxiety test: 10% change from baseline sum score will be classify as significant change
Child's anxiety level at induction
mYpas scale: 10% change from baseline sum score will be classify as significant change

Full Information

First Posted
January 8, 2014
Last Updated
July 30, 2019
Sponsor
Prince of Songkla University
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1. Study Identification

Unique Protocol Identification Number
NCT04039269
Brief Title
Long Term Memory Preoperative Preparation Reduce Post Operative Behavioral Change
Official Title
Could Long Term Memory Created by Preoperative Video Information Reduce Post Operative Behavioral Change?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (Actual)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior, Agitation
Keywords
Post operative Behavioral Changes, Pediatric, Long term memory, video

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
192 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multiple (watch > 3 times)
Arm Type
Active Comparator
Arm Description
Preoperative video information
Arm Title
single (watch 1 time)
Arm Type
Active Comparator
Arm Description
Preoperative video information
Arm Title
conventional (do not watch)
Arm Type
No Intervention
Arm Description
Do not watch video
Intervention Type
Other
Intervention Name(s)
Preoperative video information
Primary Outcome Measure Information:
Title
Incidences of post operative behavioral changes
Description
Use PHBQ (post operative behavioral questionnaire) Postive for postoperative behavioral change: 10% change from baseline sum score
Time Frame
up to3 months post operative period
Secondary Outcome Measure Information:
Title
Incidences of Emergence agitation
Description
PAED scale, PAED scale > 10 will be classified as positive for emergence agitation
Time Frame
evaluate PAED scale in the first 5 minutes after patient arrive PACU
Title
Parental's anxiety level at induction
Description
STATE trait anxiety test: 10% change from baseline sum score will be classify as significant change
Time Frame
Evaluate 15 minutes before start anesthesia induction
Title
Child's anxiety level at induction
Description
mYpas scale: 10% change from baseline sum score will be classify as significant change
Time Frame
mYpas will be evaluated immediately after the patient arrives into the operating room

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ngamjit Pattaravit, MD
Phone
+66897001350
Email
ngamjitp@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sasikaan Nimmaanrat, MD
Phone
+6674451651
Email
snimmaanrat@yahoo.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ngamjit Pattaravit, MD
Organizational Affiliation
Prince of Songkla University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Prince of Songkla University
City
Hat-Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thavat Chanchayanon, MD
Phone
+6674451650
Email
Chanchanon@yahoo.com
First Name & Middle Initial & Last Name & Degree
Orarat Karnjanawanichkul, MD
First Name & Middle Initial & Last Name & Degree
Chanattee Kitsiripan, MD

12. IPD Sharing Statement

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Long Term Memory Preoperative Preparation Reduce Post Operative Behavioral Change

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