UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058034 |
|---|---|
| Receipt number | R000066333 |
| Scientific Title | PARENTAL STRESS IN A TERTIARY PAEDIATRIC INTENSIVE CARE UNIT - A PROSPECTIVE OBSERVATIONAL STUDY |
| Date of disclosure of the study information | 2025/05/31 |
| Last modified on | 2025/05/31 16:34:20 |
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Basic information
Public title
Parental stress scale in PICU
Acronym
PSS:PICU
Scientific Title
PARENTAL STRESS IN A TERTIARY PAEDIATRIC INTENSIVE CARE UNIT - A PROSPECTIVE OBSERVATIONAL STUDY
Scientific Title:Acronym
PSS:PICU
Region
| Asia(except Japan) |
Condition
Condition
Parental stress level assessment based on PS::PICU scale
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess stress levels of parents of children admitted to PICU.
Basic objectives2
Others
Basic objectives -Others
To study the relationship of socioeconomic factors, demographic variables and illness levels with parental stress levels
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess stress levels of parents of children admitted to PICU using PSS:PICU scale.
Key secondary outcomes
To identify common parental stressors during their child's critical illness.
To study the relationship of socioeconomic factors, demographic variables and illness levels with parental stress levels
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 2 | months-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Children 2 months to 18 years old admitted in PICU for atleast 24 hours
Key exclusion criteria
Children who sustained cardiac arrest during current admission or prior to PICU admission
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Mullai |
| Middle name | |
| Last name | Baalaaji |
Organization
Kovai Medical Center and Hospital
Division name
Pediatric Intensive Care Unit
Zip code
641014
Address
Avinashi Road, Coimbatore, India
TEL
(+91)9855050822
drmullaibaalaaji@gmail.com
Public contact
Name of contact person
| 1st name | Mullai |
| Middle name | |
| Last name | Baalaaji |
Organization
Kovai Medical Center and Hospital
Division name
Pediatric Intensive Care Unit
Zip code
641014
Address
Avinashi Road, Coimbatore, India
TEL
(+91)9855050822
Homepage URL
drmullaibaalaaji@gmail.com
Sponsor or person
Institute
Kovai Medical Center and Hospital, Coimbatore
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kovai Medical Center and Hospital
Address
Avinashi Road, Coimbatore, India
Tel
(+91)9855050822
drmullaibaalaaji@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
https://docs.google.com/document/d/1Lvzum42Gyp1Lzkl24jELCcBPlGI_voUr/edit
Publication of results
Unpublished
Result
URL related to results and publications
https://docs.google.com/document/d/1Lvzum42Gyp1Lzkl24jELCcBPlGI_voUr/edit
Number of participants that the trial has enrolled
249
Results
Parental stress was moderate. There was significant association among those with respiratory distress cardiorespiratory failure and parent stress scale. Significant association was seen for hemodynamic support invasive illness and maximum respiratory support and parent stress scale.
Results date posted
| 2025 | Year | 05 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Majority of the parental age belonged to 36 to 40 years and of male gender.
Majority of the children admitted in PICU belonged to the age group of 1 to 10 years and male gender. The median length of stay in PICU and ward was 3 days.
Participant flow
Number screened - 415
Number included - 249
Adverse events
None
Outcome measures
There was no significant association between demographic, family profile and parent stress scale. Significant association was seen between patients referred from outside, admitted elsewhere for current illness and parent stress scale.
There was significant association among those with respiratory distress, cardiorespiratory failure and parent stress scale. Significant association was seen for hemodynamic support, invasive illness and maximum respiratory support and parent stress scale.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
There was no significant association between demographic, family profile and parent stress scale. Significant association was seen between patients referred from outside, admitted elsewhere for current illness and parent stress scale.
There was significant association among those with respiratory distress, cardiorespiratory failure and parent stress scale. Significant association was seen for hemodynamic support, invasive illness and maximum respiratory support and parent stress scale.
Management information
Registered date
| 2025 | Year | 05 | Month | 31 | Day |
Last modified on
| 2025 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066333
