Affective Bonding in Mothers and Their Premature Newborn
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ClinicalTrials.gov Identifier: NCT03070158 |
Recruitment Status
:
Not yet recruiting
First Posted
: March 3, 2017
Last Update Posted
: March 3, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Premature Infant | Behavioral: Attachment Promotion | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 148 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | 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. |
Masking: | Single (Participant) |
Primary Purpose: | Supportive Care |
Official Title: | Efficacy of a Nursing Intervention in the Mother-premature Infant Affective Bond |
Estimated Study Start Date : | March 2017 |
Estimated Primary Completion Date : | March 2018 |
Estimated Study Completion Date : | May 2018 |
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.
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Behavioral: Attachment Promotion
Attachment Promotion consists of:
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No Intervention: Usual Care
Mothers will continue to receive usual which consist in education session about newborn care in home.
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- 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)
- 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)

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Ages Eligible for Study: | 29 Weeks to 36 Weeks (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070158
Contact: Beatriz Villamizar- carvajal, PhD | 5776345745 | beatriz@uis.edu.co | |
Contact: Mayut Delgado-Galeano, Msc | 573204790489 | mayutdelgado@gmail.com |
Colombia | |
Nursing School, Universidad Industrial de Santander | Not yet recruiting |
Bucaramanga, Santander, Colombia, 680002 | |
Contact: Beatriz Villamizar- Carvajal, PhD 576345745 beatriz@uis.edu.co | |
Principal Investigator: Beatriz Villamizar- Carvajal, RN PhD | |
Sub-Investigator: Carolina Vargas- Porras, RN MSc | |
Sub-Investigator: Mayut Delgado- Galeano, RN MSc |
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:
Responsible Party: | Beatriz Villamizar Carvajal, Principal Investigator, Universidad Industrial de Santander |
ClinicalTrials.gov Identifier: | NCT03070158 History of Changes |
Other Study ID Numbers: |
1900 |
First Posted: | March 3, 2017 Key Record Dates |
Last Update Posted: | March 3, 2017 |
Last Verified: | February 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Beatriz Villamizar Carvajal, Universidad Industrial de Santander:
Premature Infant Mother-Infant Interaction Acoustic stimulation/methods |
Touch Visual Stimulation Vestibule, Labyrinth/physiology |
Additional relevant MeSH terms:
Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications |