Status:
COMPLETED
Maternal Involvement in Pain Management in NICU
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions:
Procedural Pain
Mother-Infant Interaction
Eligibility:
All Genders
1-1 years
Phase:
NA
Brief Summary
Infants admitted to Neonatal Intensive Care Unit (NICU) may experience a negative impact due to multiple painful and stressful procedures during their hospitalization. The American Academy of Pediatri...
Detailed Description
This study is a prospective, randomized controlled trial with a 2x2 crossover design. Study population include newborns admitted to NICU that require a heel stick procedure after the first week of lif...
Eligibility Criteria
Inclusion
- For infants:
- \- Infants born ≥ 23 weeks of gestational age who require an heel stick procedure, after the first week of life
- For mothers:
- \- Mothers' age over 18 years and good comprehension of Italian language
- For nurses:
- \- Nurses or pediatric nurses with professional experience in NICU ≥ 6 months who decide to participate at the study
Exclusion
- For infants:
- Enteral and/or parenteral sedation/analgesia ongoing or suspended less than 4 hours from the beginning of the procedure
- Infants who receive multiple painful procedures at the same time
- For mothers:
- bad comprehension of Italian language
- age under 18 years
- For nurses:
- Nurses and pediatric nurses with professional experience in NICU ≤ 6 months
- Nurses and pediatric nurses who don't give consent to study participation
Key Trial Info
Start Date :
May 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04883944
Start Date
May 17 2021
End Date
May 16 2022
Last Update
May 23 2022
Active Locations (1)
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1
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, NICU
Milan, MI, Italy, 20122