Affective Bonding in Mothers and Their Premature Newborn

Not Applicable

• Conditions: Premature Infant
• Interventions: Behavioral: Attachment Promotion

• Registration Number: NCT03070158
• Lead Sponsor: Universidad Industrial de Santander

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.

Detailed Description

The premature newborn has a high need for positive interactions, which is a challenge for him, due to biological immaturity, and for his mother because of the level of stress that this situation generates. Behavioral and developmental interventions are needed to address the unique behaviors of preterm infants and the interactive capacities of the mother-newborn premature dyad. The project will be conducted in 18 months. The assignment of the mothers to each group will be like that: First at all, mother will be assignment to control group. They will received usual care when achieve the total of 74 mothers, the mothers will be assigned to intervention group.

Study Timeline

• Study First Submitted: 2017-02-28
• Study First Submitted QC: 2017-02-28
• Study First Posted: 2017-03-03
• Study Start: 2017-05-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-06
• Last Update Posted: 2020-02-07
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Attachment Promotion Intervention	Attachment Promotion	Mothers 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.

Primary Outcome Measures

Name	Time	Method
Affective bonding score	1-6 weeks	Changes in the mean score of the nursing outcome: affective bonding measure with the NOC(Nursing Outcomes Classification)

Secondary Outcome Measures

Name	Time	Method
Coping adaptation score	1-6 weeks	Changes in the mean score of the coping measure with the Coping adaptation Processing Scale Abbreviated (CAPS Abbreviated - Spanish)

Trial Locations

Locations (3)

Nursing School, Universidad Industrial de Santander; 🇨🇴 Bucaramanga, Santander, Colombia

Clinica Materno Infantil San Luis; 🇨🇴 Bucaramanga, Santander, Colombia

Hospital Universitario de Santander; 🇨🇴 Bucaramanga, Santander, Colombia