KK Women's and Children's Hospital
Singapore, 229899
NCT Number: NCT04637113
What is the problem? Every year about 2.5 million children are affected by critical illness and require admission to the pediatric intensive care unit (PICU). However, both children and their parents may encounter difficulties after critical illness. Children affected physically may have difficulties in breathing, eating, and drinking. Parents have reported feeling symptoms of stress such as nightmares and excessive worries after PICU discharge. Currently, the investigators do not know when and how the problems unfold and what harm does it cause. Without this information, healthcare professionals are not equipped to support these families after PICU discharge.
Research Plan? To understand how critical illness could affect the physical, emotional, and social experiences of children age 1 month to 18 years of age and their parents in the first 6 months after a PICU admission.
144 children and their parents will be followed from the time of PICU admission to 6 months after discharge. Children and their parents will complete surveys to measure physical, social, emotional and function outcomes. A total of 12 families will be interviewed at 1 and 3 months after PICU discharge. Using the data provided to map out any trend or changes in this information over time.
Why is this study important? To better understand the experience and health consequences of children and their parents in the first six months after PICU admission. This information would help to identify potential areas to improve the negative consequence of children and their families after a severe illness. Results will be shared to the PICU survivors and their families, national organizations, international pediatric intensive care community to improve the experiences and health outcomes following a PICU admission.
Looking for future studies?
Notify Me1 month–70 year
All sexes
Observational
Singapore, 229899
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Child inclusion criteria:
Parents inclusion criteria:
Exclusion criteria
This is a non-interventional study.
Time frame: baseline and 6 months
The PedsQL instrument consists of 23 items that evaluate 4 domains: physical, emotional, social, and school functioning with summary scores available for physical and psychological health. It is scored using a 5-point Likert scale from 0 (never) to 4 (A lot) with a possible score of 0 to 100.
Time frame: 6 months
The Paediatric Quality of Life Inventory Version 4.0 (PedsQL™) total score will be used to compare the difference between Chinese, Malay, and Indian families. This instrument consists of 23 items that evaluate 4 domains: physical, emotional, social, and school functioning with summary scores available for physical and psychological health. It is scored using a 5-point Likert scale from 0 (never) to 4 (A lot) with a possible score of 0 to 100.
Time frame: 6 months
PTSD Checklist for DSM-5 (PCL-5) assesses the 20 Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition (DSM-5) symptoms of post-traumatic stress disorder. The 20 items self-report measure is scored on a rating a 5-point Likert scale from 0 (Not at all) to 4 (Extremely). The symptoms severity score ranges from 0-80. A cut-off score between 31-33 is indicative of probable PTSD.
KK Women's and Children's Hospital
Other Gov
Singapore's Health Outcomes After Critical Illness in Kids: the SHACK Study: A Longitudinal Mixed-methods Study in Singapore to Explore the Health Outcomes of Children and Their Parents in the First Six Months After PICU Discharge
Acronym: SHACK
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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