UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057972 |
|---|---|
| Receipt number | R000066279 |
| Scientific Title | A prospective study to measure parent satisfaction using the shortened "Empowerment of parents in the intensive care" (EMPATHIC-30) questionnaire in a tertiary care Pediatric Intensive Care Unit |
| Date of disclosure of the study information | 2025/05/26 |
| Last modified on | 2025/05/26 17:55:28 |
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Basic information
Public title
Parental satisfaction survey in a tertiary care PICU
Acronym
EMPATHIC30
Scientific Title
A prospective study to measure parent satisfaction using the shortened "Empowerment of parents in the intensive care" (EMPATHIC-30) questionnaire in a tertiary care Pediatric Intensive Care Unit
Scientific Title:Acronym
EMPATHIC-30 PICU
Region
| Asia(except Japan) |
Condition
Condition
Prospective observational study to measure parental satisfaction using EMPATHIC-30 Questionnaire
Classification by specialty
| Pediatrics | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Primary objective was to measure parental satisfaction with the care received by their children in PICU using EMPATHIC-30
Basic objectives2
Others
Basic objectives -Others
Secondary objective was to determine the effects of parent and patient related factors on parental satisfaction as measured by the EMPATHIC-30 Questionnaire.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Parental satisfaction with the care received by their children in PICU using EMPATHIC-30 at the time of discharge from PICU
Key secondary outcomes
Determine the effects of parent and patient related factors on parental satisfaction as measured by the EMPATHIC-30 Questionnaire at the time of discharge from PICU.
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
Consecutive children age 2 months to 18 years old with anticipated PICU stay for more than 48 hours
Key exclusion criteria
1. Children who sustained out of hospital cardiac arrest
2. Children who sustained cardiac arrest in PICU
Target sample size
350
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, India
Institute
Department
Personal name
Funding Source
Organization
No funding
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 | 26 | Day |
Related information
URL releasing protocol
https://docs.google.com/document/d/1nujpsH2ISD3YpRA-CMA-7CYsMqrWMv2m/edit
Publication of results
Unpublished
Result
URL related to results and publications
https://docs.google.com/document/d/1J01kCJhce6PRjb9NriLeTmc9aoyeqA6V/edit
Number of participants that the trial has enrolled
384
Results
The mean (SD) score of satisfaction as per the entire questionnaire put together was 5.4 (0.7) indicating a high level of overall satisfaction as perceived by the family members.
Results date posted
| 2025 | Year | 05 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 384 children were enrolled and their parents participated in the study. Majority of the children belonged to the 1-5 years age group (n-178, 46%), followed by children more than 5 years age group (n-155, 40%). Male children slightly predominated in the study cohort (n-218, 56.8%). Mother of the admitted children completed the survey in the majority (n-244, 63.5%) followed by father (n-126, 32.8%) and other caregivers (n-14, 3.6%). Majority of the family members who participated were graduates (n-215, 56%) and were skilled workers (n-125, 32.6%). Comparing the socio-economic strata, majority of the study participants belonged to lower middle socio-economic class11 (n-206, 53.6%), followed by upper lower (n-89, 23.2%) and upper middle class (n-87, 22.7%). A total of 52% (n-201) had visited the health centre before prior to the current admission. Majority of the study participants (n-306, 79.7%) had no prior visits or exposure to Pediatric Intensive care facilities.
Participant flow
Number of children screened - 592
Number of children excluded - 208
Number of children enrolled - 384
Adverse events
No adverse events
Outcome measures
In our study, no statistically significant differences in the mean scores were seen between the groups based on socio economic status, prior visit to the centre, type of illness, type of admission, education status, prior PICU admissions and length of PICU stay. Also no statistically significant difference was noted between the groups who were discharged versus who left Against Medical Advice. Comparing patient related factors, there was a significant difference in the information domain [Mean (SD) 5.3 (1.0), 5.47 (0.7) respectively],and parent participation domains [Mean (SD) 5.37 (0.9), 5.55 (0.6) respectively], for parents of ventilated children compared to non-ventilated, with statistical significance. Parents of younger children (those under five years old) scored significantly lower than parents of older children (those over five years old) in every domain. Parents of male children consistently scored higher than parents of female children across all domains, with the most significant differences observed in the Care and Cure, and Professional Attitude domains.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We have collected the experiences and parental perceptions on their children stay in PICU using a validated EMPATHIC-30 questionnaire. Majority of the participants were satisfied, especially in the professional attitude and care and treatment domains. There was a lower perceived satisfaction in the information and parental participation domain of ventilated children, which reveals an area for improvement. Open-ended questions revealed mostly positive experiences during multiple timelines of the PICU stay, however the area for improvement was noted regarding the perceived prolonged waiting for discharge from PICU to ward.
Management information
Registered date
| 2025 | Year | 05 | Month | 26 | Day |
Last modified on
| 2025 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066279
