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Clinical Trials/NCT04785482
NCT04785482
Completed
N/A

Parents Post-traumatic Stress Before and After Their Infant's Second Palliative Heart Surgery: The PaTHS Descriptive Correlational Longitudinal Study

Children's Mercy Hospital Kansas City1 site in 1 country22 target enrollmentMarch 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Single-ventricle
Sponsor
Children's Mercy Hospital Kansas City
Enrollment
22
Locations
1
Primary Endpoint
Measure the level of parental post-traumatic stress two to four weeks before their infant's second palliative heart surgery
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The primary objective of this study is to measure parent's post-traumatic stress before and after their infant's second palliative heart surgery for single ventricle congenital heart disease. The investigators will use the posttraumatic stress disorder checklist for the DSM-V (PCL-5) to measure levels 2-4 weeks before and after the infant's second heart surgery. The investigators aim to describe the levels at the two-time points, compare the scores, and identify demographic information that correlates with the scores.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
June 9, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Children's Mercy Hospital Kansas City
Responsible Party
Principal Investigator
Principal Investigator

Melissa Elliott

Advanced Practice Registered Nurse

Children's Mercy Hospital Kansas City

Eligibility Criteria

Inclusion Criteria

  • Parent who is 18 years or older of an infant with SVCHD
  • Following with CHAMP through Children's Mercy Hospital. Any person personally identifying as a parent of the child, who lives in the same household as the infant, and who will provide primary care after discharge from the hospital is eligible to participate.

Exclusion Criteria

  • Parents of an SVCHD infant who is undergoing end-of-life care, determined by the primary care team.

Outcomes

Primary Outcomes

Measure the level of parental post-traumatic stress two to four weeks before their infant's second palliative heart surgery

Time Frame: on average at 4-6 months of age

Measure level using the posttraumatic stress disorder checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition. The scores range 0-80 with scores greater than or equal to 31 suggest provisional Posttraumatic stress disorder diagnosis.

Secondary Outcomes

  • Measure the level of parental post-traumatic stress two to four weeks after discharge following their infant's second palliative heart surgery.(On average 5-6 months of age)

Study Sites (1)

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