Trial record 1 of 1 for: NCT04635150
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National Evaluation of the Close Collaboration With Parents Training (VVME5)
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|ClinicalTrials.gov Identifier: NCT04635150|
Recruitment Status : Completed
First Posted : November 18, 2020
Last Update Posted : November 18, 2020
Turku University Hospital
University of Turku
Information provided by (Responsible Party):
Liisa Lehtonen, Turku University Hospital
The aim of this study was to evaluate the effects of an educational intervention for neonatal staff on parent-infant physical closeness during their infant's stay in the Neonatal Intensive Care Unit (NICU) and parents' and staff perception on family centered care in the unit. This pre-post intervention study was carried out in nine hospitals in Finland in 2012 through 2018. Data was collected by using daily parental diaries, daily text message questions to parents and an audit interview for the staff.
|Condition or disease||Intervention/treatment||Phase|
|Parent-Child Relations Parenting Infant, Newborn, Disease||Behavioral: Close Collaboration with Parents||Not Applicable|
Show detailed description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||768 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Pre-post intervention study with different cohorts before and after the intervention.|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||National Evaluation of the Close Collaboration With Parents Training. Enhancing Parents' Presence and Participation During Neonatal Intensive Care.|
|Actual Study Start Date :||May 30, 2012|
|Actual Primary Completion Date :||September 30, 2018|
|Actual Study Completion Date :||September 30, 2018|
Experimental: Post-intervention parents and staff
An educational intervention for the multidisciplinary staff of a neonatal intensive care unit.
Behavioral: Close Collaboration with Parents
Close Collaboration with Parents Training Program is an educational intervention for multidisciplinary NICU staff initially developed and implemented at Turku University Hospital to promote FCC. The intervention consists of four phases lasting 4 to 5 months each. First the healthcare staff learn to observe infant behavior. This phase aims at identifying the individual needs and features of each infant. After that, the staff observe infant behavior with the parents and learn to actively listen to parents' perceptions about their infant. During the phase III, staff learn to know the individual story of the family and their infant, which supports partnership between staff and parents. Finally, staff learn to integrate parents in decision-making and collaboratively plan the transition to home. The training is delivered through facilitator-network model in which local mentors are trained by the trainer mentors and supervisors.
Primary Outcome Measures :
- Parental Closeness Diary of parents' presence [ Time Frame: During the time the infant was cared for in the neonatal unit (up to 3 months), applicable to both cohorts of infants: those recruited before and after the intervention. ]Daily Closeness Diary including space for both mothers and fathers to indicate their presence in the neonatal unit (minutes/per day in 5-minute accuracy) to be filled in during all hospital days of the infant (up to 3 months).
- Parental Closeness Diary of parent-infant skin-to-skin contact [ Time Frame: During the time the infant was cared for in the neonatal unit (up to 3 months), applicable to both cohorts of infants: those recruited before and after the intervention. . ]Daily Closeness Diary including space for both mothers and fathers to indicate skin-to-skin contact with their infant (minutes/per day in 5-minute accuracy) to be filled in during all hospital days of the infant (up to 3 months). Skin-to-skin contact is defined as the infant is lying naked on a parent's chest.
- Daily text message questions to both mothers and fathers/partners about parents' satisfaction to family centered care [ Time Frame: During the time the infant was cared for in the neonatal unit (up to 3 months), applicable to both cohorts of infants: those recruited before and after the intervention. ]Both parents received one question (randomly out of 9 questions) every evening at 9 pm to report their satisfaction about the specific issue during that day.
- Web questions for the staff about the quality of family centered care they have provided during their work shift [ Time Frame: Three months before and three months after the intervention. ]Each staff member responded to one web question (randomly out of 8 questions) after each workshift about the quality of family centered care they had provided that day.
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