Long Term Memory Preoperative Preparation Reduce Post Operative Behavioral Change

Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04039269
• Other study ID #: PSUEA2
• Status: Recruiting
• Phase: N/A
• Start date: December 2013
• Est. completion date: May 2020

Study information

• Verified date: July 2019
• Source: Prince of Songkla University
• Contact: Ngamjit Pattaravit, MD
• Phone: +66897001350
• Email: ngamjitp[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Agitation
• Behavior
• Problem Behavior

Intervention

Other:
• Preoperative video information

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Prince of Songkla University	Hat-Yai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidences of Emergence agitation	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
Secondary	Parental's anxiety level at induction	STATE trait anxiety test: 10% change from baseline sum score will be classify as significant change	Evaluate 15 minutes before start anesthesia induction
Secondary	Child's anxiety level at induction	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