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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04039269
Other study ID # PSUEA2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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