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Parental Anxiety and Its Relationship With Pediatric Patients' Post-operative Responses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01993992
Recruitment Status : Unknown
Verified July 2015 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 25, 2013
Last Update Posted : July 8, 2015
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
Post-operative delirium had multiple risk factors, such as pre-operative anxiety status, post-operative pain, and anesthetic method. We currently decrease pre-operative anxiety by parental accompanying until the children put to sleep. However, references indicate that parental anxiety can increase the post-operative delirium. Heart rate variability was used to measure the anxiety status of parents. We think sympathetic tone elevation measured by heart rate variability may not induce by anxiety alone, thus we want to explore this question by using Stat-Trait Anxiety Inventory questionnaire.

Condition or disease
Post-operative Delirium Children Anxiety

Detailed Description:

Outcome measures

  1. Post-operative emergence delirium, observed with an average duration up to 24 hours
  2. Sedatives used in recovery unit

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Parental Anxiety and Its Relationship With Pediatric Patients' Post-operative Responses
Study Start Date : December 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Delirium




Primary Outcome Measures :
  1. degree of emergence delirium [ Time Frame: after operation, with an average duration up to 24 hours ]

Secondary Outcome Measures :
  1. recovery room stay time [ Time Frame: after operation, with an average duration up to 24 hours ]
  2. Sedatives used in recovery room [ Time Frame: after operation, with an average duration up to 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Age younger than 16-year-old who required surgery
Criteria

Inclusion criteria:

  • American Society Anesthesia (ASA) risks classification I or II

Exclusion criteria:

  • Parents who have cognitive problems
  • Parents who have difficulty finishing questionnaire

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): NCT01993992


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: YI-CHIA WANG National Taiwan University Hospital
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01993992    
Other Study ID Numbers: 201310021RIND
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: July 2015
Keywords provided by National Taiwan University Hospital:
Anesthesia
Additional relevant MeSH terms:
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Delirium
Anxiety Disorders
Mental Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders