Effects of Father-Neonate Skin-to-Skin Contact on Attachment (FNSSC)

September 1, 2016 updated by: Er-Mei Chen, National Taipei University of Nursing and Health Sciences

Effects of Father-Neonate Skin-to-Skin Contact on Attachment: A Randomised Controlled Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study examines how skin-to-skin contact between father and newborn affects the attachment relationship. A randomized controlled trial was conducted at a regional teaching hospital and a maternity clinic in northern Taiwan. The study recruited 83 first-time fathers aged 20 years or older. By block randomization, participants were allocated to an experimental (n=41) or a control group (n=42). With the exception of skin-to-skin contact (SSC), participants from each group received the same standard care. Both groups also received an Early Childcare for Fathers nursing pamphlet. During the first three days postpartum, the intervention group members were provided a daily SSC intervention with their respective infants. Each intervention session lasted at least 15 minutes in length. The outcome measure was the Paternal Attachment Questionnaire (PAQ).

Four field experts of clinical obstetrics and pediatrics validated the developed father-neonate SSC intervention. A description of the intervention used in this study is as follows:

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.

Meanwhile, intervention-group participants were provided with the nursing pamphlet, Early Childcare for Fathers, and briefed on its contents at hospital admission. Upon delivery, each newborn infant received immediate SSC with the mother and was then provided neonatal nursing before being placed temporarily into an incubator for observation. After the infant was confirmed as being in a "quiet alert" state, defined as eyes open and bright, breathing normal, and sensitive and responsive to stimuli, a researcher led the father into the nursery, helped him hold his infant, and facilitated initial SSC. Immediately afterward, the researcher - in accordance with each participant's expressed preference - either withdrew from the room or observed the infant from an appropriate distance. Two further father-infant SSC sessions were held on day 2 and day 3, respectively, in either the nursery or maternity ward. The sessions took place in a secluded section of the nursery or ward about two hours after one of the daily feedings and only after the infant had been bathed, towel dried, and fitted with a diaper. The session space included a comfortable armchair, a footrest, a partition screen, a pillow, and a towel or blanket. The ambient temperature was held at a constant 25~27°C.

Prior to touching their infant, participants wore a loose-fitting, front-button shirt or hospital smock and washed their hands. They then sat in the provided armchair and exposed their chest. A pillow and footrest were also made available for use. After the researcher confirmed the safety of all preparations, participants were given their infant to hold. The infant was cradled on the participant's chest in a fetal position, with the head held upwards either vertically or at a 30~60° angle. The exposed back of the infant was then covered by a blanket or clothing. The participant supported the infant with his hands placed on the infant's shoulder and back. Next, he made eye contact with the infant. Touch and soft voice contact commenced only after the infant was appropriately relaxed, as indicated by relaxed eyebrows, forehead, and chin muscles; slightly curled hands; a comfortably curled body position; and calm smile.18 Previous studies found that infants feel most at ease within 15 minutes of SSC with their parents and that verbal and non-verbal communication typically commences within this time period as well.16, 20 Thus, the researchers defined the minimum duration of SSC sessions as 15 minutes, with sessions longer than this duration allowed to continue until either consciously ended by the father or interrupted by other infant-care priorities.

After receiving institutional review board (IRB) approval for this study in November 2012, a random allocation computer program generated a random stratified allocation table that was used to direct participant recruitment.23 Upon hospital admission, participants in both the intervention and control groups received the Early Childcare for Fathers nursing pamphlet in order to promote understanding of early infant care and complete the pretest PAQ instrument. Afterward, intervention-group participants were orally briefed on pamphlet contents and shown how to successfully perform father-infant SSC. These participants subsequently engaged in at least one >15-minute SSC session with their infant on each of the first three postpartum days. On the other hand, control-group participants received only standard nursing care after receiving the pamphlet. After the 3-day study period, all participants completed and submitted the demographic survey form and post-test PAQ.

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: skin-to-skin contact (SSC)
Experimental: a daily skin-to-skin contact (SSC) at least 15 minutes in length
Other: skin to skin contact
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.
No Intervention: Control: hospital routine care
As the hospital routine. Allow the father to visit the neonate, touching the neonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Paternal Attachment measured by the Paternal Attachment Questionnaire (PAQ)
Time Frame: the first three postpartum days
measured by the Paternal Attachment Questionnaire (PAQ)
the first three postpartum days

Collaborators and Investigators

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

Sponsor

National Taipei University of Nursing and Health Sciences

Investigators

  • Study Director: Chien-Huei Kao, PhD, National Taipei University of Nursing and Health Sciences

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

December 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimate)

September 1, 2016

Study Record Updates

Last Update Posted (Estimate)

September 2, 2016

Last Update Submitted That Met QC Criteria

September 1, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CGH-P101077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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