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Long Term Memory Preoperative Preparation Reduce Post Operative Behavioral Change

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ClinicalTrials.gov Identifier: NCT04039269
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Ngamjit Pattaravit, 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.

Condition or disease Intervention/treatment Phase
Behavior Agitation Other: Preoperative video information Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Could Long Term Memory Created by Preoperative Video Information Reduce Post Operative Behavioral Change?
Actual Study Start Date : December 2013
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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


  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039269


Contacts
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Contact: Ngamjit Pattaravit, MD +66897001350 ngamjitp@yahoo.com
Contact: Sasikaan Nimmaanrat, MD +6674451651 snimmaanrat@yahoo.au

Locations
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Thailand
Faculty of Medicine, Prince of Songkla University Recruiting
Hat-Yai, Songkhla, Thailand, 90110
Contact: Thavat Chanchayanon, MD    +6674451650    Chanchanon@yahoo.com   
Sub-Investigator: Orarat Karnjanawanichkul, MD         
Sub-Investigator: Chanattee Kitsiripan, MD         
Sponsors and Collaborators
Prince of Songkla University
Investigators
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Principal Investigator: Ngamjit Pattaravit, MD Prince of Songkla University
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Responsible Party: Ngamjit Pattaravit, Assistant Professor, Dr, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT04039269    
Other Study ID Numbers: PSUEA2
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Keywords provided by Ngamjit Pattaravit, Prince of Songkla University:
Post operative Behavioral Changes
Pediatric
Long term memory
video
Additional relevant MeSH terms:
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Problem Behavior
Behavioral Symptoms