Long Term Memory Preoperative Preparation Reduce Post Operative Behavioral Change

Not Applicable

• Conditions: Behavior; Agitation
• Interventions: Other: Preoperative video information

• Registration Number: NCT04039269
• Lead Sponsor: Prince of Songkla University

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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-08
• Status Verified: 2019-07
• Study First Submitted QC: 2019-07-30
• Last Update Submitted: 2019-07-30
• Study First Posted: 2019-07-31
• Last Update Posted: 2019-07-31
• Primary Completion: 2020-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 192

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
single (watch 1 time)	Preoperative video information	Preoperative video information
Multiple (watch > 3 times)	Preoperative video information	Preoperative video information

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidences of Emergence agitation	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
Child's anxiety level at induction	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
Parental's anxiety level at induction	Evaluate 15 minutes before start anesthesia induction	STATE trait anxiety test: 10% change from baseline sum score will be classify as significant change

Trial Locations

Locations (1)

Faculty of Medicine, Prince of Songkla University; 🇹🇭 Hat-Yai, Songkhla, Thailand