Affective Bonding in Mothers and Their Premature Newborn
Efficacy of a Nursing Intervention in the Mother-premature Infant Affective Bond
1 other identifier
interventional
148
1 country
3
Brief Summary
This experimental study will determine the effectiveness of nursing intervention "the attachment promotion" to increase the affective bonds between mothers and their premature infants. The assignment of the mothers to the control group will receive usual care, the mothers will be assigned to intervention group will receive the intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2017
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2017
CompletedFirst Posted
Study publicly available on registry
March 3, 2017
CompletedStudy Start
First participant enrolled
May 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedFebruary 7, 2020
February 1, 2020
3.7 years
February 28, 2017
February 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Affective bonding score
Changes in the mean score of the nursing outcome: affective bonding measure with the NOC(Nursing Outcomes Classification)
1-6 weeks
Secondary Outcomes (1)
Coping adaptation score
1-6 weeks
Study Arms (2)
Attachment Promotion Intervention
EXPERIMENTALMothers will receive the intervention which includes an education session about newborn care, training in multisensory stimulation with the intervention ATVV and two domiciliary visits to follow up the mother and her premature infant.
Usual Care
NO INTERVENTIONMothers will continue to receive usual which consist in education session about newborn care in home.
Interventions
Attachment Promotion consists of: 1. Education session about newborn and mother care. 2. Training in multisensory stimulation using the ATVV Intervention (auditory, tactile, visual and vestibular) 3. Two domiciliary visits to follow up and to give education about newborn care and ATVV Intervention. 4. Daily Phone follows up.
Eligibility Criteria
You may qualify if:
- Premature Infant:
- Neonates who had been hospitalized in the neonatal care unit, with ages ranging from 29 - 36.6/7 weeks gestation at birth.
- Apgar to the minute and five minutes greater to 7/10
- Mother:
- Mother with nursing diagnosis: Risk of impaired attachment.
- Mother with a neonate who had hospitalized in the neonatal care unit, with ages ranging from 29 - 36.6/7 weeks of gestation at birth
- Mother living in the metropolitan perimeter of the city of Bucaramanga
You may not qualify if:
- Newborn:
- Infants that underwent surgery
- Infants with neurological injury.
- Congenital cardiac abnormalities, severe deformities, grade III intraventricular hemorrhage.
- Mother:
- Mother with limitations: hearing, motor and / or mental handicap-measured through the Abbreviated Mental Test (minimental), that prevent the intervention.
- Mother consuming psychoactive substances.
- With mental alterations, verified in the medical history.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Nursing School, Universidad Industrial de Santander
Bucaramanga, Santander Department, 680002, Colombia
Clinica Materno Infantil San Luis
Bucaramanga, Santander Department, 680003, Colombia
Hospital Universitario de Santander
Bucaramanga, Santander Department, 680003, Colombia
Related Publications (5)
Femitha P, Bhat BV. Early neonatal outcome in late preterms. Indian J Pediatr. 2012 Aug;79(8):1019-24. doi: 10.1007/s12098-011-0620-9. Epub 2011 Dec 10.
PMID: 22161578BACKGROUNDKelly MM. Comparison of functional status of 8- to 12-year-old children born prematurely: an integrative review of literature. J Pediatr Nurs. 2012 Aug;27(4):299-309. doi: 10.1016/j.pedn.2011.03.010. Epub 2011 May 11.
PMID: 22703676BACKGROUNDPickler RH, McGrath JM, Reyna BA, McCain N, Lewis M, Cone S, Wetzel P, Best A. A model of neurodevelopmental risk and protection for preterm infants. J Perinat Neonatal Nurs. 2010 Oct-Dec;24(4):356-65. doi: 10.1097/JPN.0b013e3181fb1e70.
PMID: 21045616BACKGROUNDHowland LC, Pickler RH, McCain NL, Glaser D, Lewis M. Exploring biobehavioral outcomes in mothers of preterm infants. MCN Am J Matern Child Nurs. 2011 Mar-Apr;36(2):91-7. doi: 10.1097/NMC.0b013e318205587e.
PMID: 21350371BACKGROUNDForcada-Guex M, Borghini A, Pierrehumbert B, Ansermet F, Muller-Nix C. Prematurity, maternal posttraumatic stress and consequences on the mother-infant relationship. Early Hum Dev. 2011 Jan;87(1):21-6. doi: 10.1016/j.earlhumdev.2010.09.006. Epub 2010 Oct 15.
PMID: 20951514BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beatriz Villamizar- Carvajal, PhD
Universidad Industrial de Santander
- STUDY CHAIR
Carolina Vargas- Porras, Msc
Universidad Industrial de Santander
- STUDY CHAIR
Mayut Delgado-Galeano, Msc
Universidad Industrial de Santander
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 28, 2017
First Posted
March 3, 2017
Study Start
May 1, 2017
Primary Completion
December 30, 2020
Study Completion
December 30, 2020
Last Updated
February 7, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share