NCT02886767

Brief Summary

This study examines the effect of skin-to-skin contact between father and newborn on the father-neonate attachment relationship. By block randomization, participants were allocated to an experimental (n=41) or a control group (n=42).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2016

Completed
Last Updated

September 2, 2016

Status Verified

September 1, 2016

Enrollment Period

11 months

First QC Date

August 29, 2016

Last Update Submit

September 1, 2016

Conditions

Keywords

skin to skin contact

Outcome Measures

Primary Outcomes (1)

  • Paternal Attachment measured by the Paternal Attachment Questionnaire (PAQ)

    measured by the Paternal Attachment Questionnaire (PAQ)

    the first three postpartum days

Study Arms (2)

skin-to-skin contact (SSC)

EXPERIMENTAL

Experimental: a daily skin-to-skin contact (SSC) at least 15 minutes in length

Other: skin to skin contact

Control: hospital routine care

NO INTERVENTION

As the hospital routine. Allow the father to visit the neonate, touching the neonate

Interventions

The researchers facilitated initial SSC between intervention-group participants and their infants within 24 hours of birthing under conditions that did not adversely affect spontaneous mother-infant SSC nor interfere with the early initiation of breastfeeding. Because it is standard practice to discharge vaginal-birth mothers on the third postpartum day, this study implemented the intervention during the first three postpartum days for both vaginal and cesarean birth cases.

skin-to-skin contact (SSC)

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • older than 20 years;
  • be at the hospital daily until discharge;
  • be a nonsmoker;
  • not have an alcohol addiction or be diagnosed with a psychological disorder; and
  • sign an informed consent agreement.

You may not qualify if:

  • the neonate gestational age less than 37 weeks;
  • the neonate vital signs unstable; and
  • the neonate with congenital abnormalities or diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Shorey S, He HG, Morelius E. Skin-to-skin contact by fathers and the impact on infant and paternal outcomes: an integrative review. Midwifery. 2016 Sep;40:207-17. doi: 10.1016/j.midw.2016.07.007. Epub 2016 Jul 5.

  • Cong X, Ludington-Hoe SM, Hussain N, Cusson RM, Walsh S, Vazquez V, Briere CE, Vittner D. Parental oxytocin responses during skin-to-skin contact in pre-term infants. Early Hum Dev. 2015 Jul;91(7):401-6. doi: 10.1016/j.earlhumdev.2015.04.012. Epub 2015 May 16.

  • Nimbalkar A, Patel D, Sethi A, Nimbalkar S. Effect of skin to skin care to neonates on pulse rate, respiratory rate SPO2 and blood pressure in mothers. Indian J Physiol Pharmacol. 2014 Apr-Jun;58(2):174-7.

  • Moore ER, Anderson GC, Bergman N. Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003519. doi: 10.1002/14651858.CD003519.pub2.

  • Cho ES, Kim SJ, Kwon MS, Cho H, Kim EH, Jun EM, Lee S. The Effects of Kangaroo Care in the Neonatal Intensive Care Unit on the Physiological Functions of Preterm Infants, Maternal-Infant Attachment, and Maternal Stress. J Pediatr Nurs. 2016 Jul-Aug;31(4):430-8. doi: 10.1016/j.pedn.2016.02.007. Epub 2016 Mar 11.

  • Stevens J, Schmied V, Burns E, Dahlen H. Immediate or early skin-to-skin contact after a Caesarean section: a review of the literature. Matern Child Nutr. 2014 Oct;10(4):456-73. doi: 10.1111/mcn.12128. Epub 2014 Apr 10.

  • Conde-Agudelo A, Belizan JM, Diaz-Rossello J. Kangaroo mother care to reduce morbidity and mortality in low birthweight infants. Cochrane Database Syst Rev. 2011 Mar 16;(3):CD002771. doi: 10.1002/14651858.CD002771.pub2.

  • Lee SB, Shin HS. [Effects of Kangaroo Care on anxiety, maternal role confidence, and maternal infant attachment of mothers who delivered preterm infants]. Taehan Kanho Hakhoe Chi. 2007 Oct;37(6):949-56. doi: 10.4040/jkan.2007.37.6.949. Korean.

  • Wang YH, Kuo HH. [The nursing experience in helping an unmarried adolescence girl to care for her premature infant]. Hu Li Za Zhi. 2006 Oct;53(5):76-83. Chinese.

  • Chen EM, Gau ML, Liu CY, Lee TY. Effects of Father-Neonate Skin-to-Skin Contact on Attachment: A Randomized Controlled Trial. Nurs Res Pract. 2017;2017:8612024. doi: 10.1155/2017/8612024. Epub 2017 Jan 17.

Study Officials

  • Chien-Huei Kao, PhD

    National Taipei University of Nursing and Health Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Nurse and graduate student of NTUNHS

Study Record Dates

First Submitted

August 29, 2016

First Posted

September 1, 2016

Study Start

December 1, 2012

Primary Completion

November 1, 2013

Study Completion

December 1, 2013

Last Updated

September 2, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share