Affective Bonding in Mothers and Their Premature Newborn

February 6, 2020 updated by: Beatriz Villamizar Carvajal, Universidad Industrial de Santander

Efficacy of a Nursing Intervention in the Mother-premature Infant Affective Bond

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Beatriz Villamizar- carvajal, PhD
  • Phone Number: 5776345745
  • Email: beatriz@uis.edu.co

Study Contact Backup

Study Locations

  • Colombia
    • Santander
      • Bucaramanga, Santander, Colombia, 680002
        • Recruiting
        • Nursing School, Universidad Industrial de Santander
        • Contact:
        • Principal Investigator:
          • Beatriz Villamizar- Carvajal, RN PhD
        • Sub-Investigator:
          • Carolina Vargas- Porras, RN MSc
        • Sub-Investigator:
          • Mayut Delgado- Galeano, RN MSc
      • Bucaramanga, Santander, Colombia, 680003
      • Bucaramanga, Santander, Colombia, 680003
        • Recruiting
        • Hospital Universitario de Santander
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 8 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Attachment Promotion Intervention
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.
Behavioral: Attachment Promotion

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.
NO_INTERVENTION: Usual Care
Mothers will continue to receive usual which consist in education session about newborn care in home.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coping adaptation score
Time Frame: 1-6 weeks
Changes in the mean score of the coping measure with the Coping adaptation Processing Scale Abbreviated (CAPS Abbreviated - Spanish)
1-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Industrial de Santander

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2017

Primary Completion (ANTICIPATED)

December 30, 2020

Study Completion (ANTICIPATED)

December 30, 2020

Study Registration Dates

First Submitted

February 28, 2017

First Submitted That Met QC Criteria

February 28, 2017

First Posted (ACTUAL)

March 3, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 7, 2020

Last Update Submitted That Met QC Criteria

February 6, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1900

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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