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Parent-Child RelationsFNSSCNCT02886767

Effects of Father-Neonate Skin-to-Skin Contact on Attachment

A study testing skin to skin contact in people with Parent-Child Relations, run by National Taipei University of Nursing and Health Sciences.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 20 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Parent-Child Relations
What is being tested?
skin to skin contact
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
No sites listed yet
Study dates
Dec 2012to Dec 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

About this study

Official title: 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).

Read the 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.

Being tested
skin to skin contact
Keywords
skin to skin contact

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • skin to skin contactOther

    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.

Study groups in NCT02886767
Study groupRoleWhat they receive
skin-to-skin contact (SSC)ExperimentalExperimental: a daily skin-to-skin contact (SSC) at least 15 minutes in length
Receives: Other: skin to skin contact
Control: hospital routine careNo interventionAs the hospital routine. Allow the father to visit the neonate, touching the neonate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Paternal Attachment measured by the Paternal Attachment Questionnaire (PAQ)

    measured by the Paternal Attachment Questionnaire (PAQ)

    Measured: the first three postpartum days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2016 (estimated)
  2. Study startDec 2012
  3. Primary completionNov 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02886767
Sponsor's protocol ID
CGH-P101077
Acronym
FNSSC
Status last verified
Sep 2016
First submitted
29 Aug 2016
Last updated
2 Sep 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 27476026
  • 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.

    PubMed 25988992
  • 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.

    PubMed 25509971
  • 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.

    PubMed 17636727
  • 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.

    PubMed 26975461
  • 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.

    PubMed 24720501
  • 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.

    PubMed 21412879
  • 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.

    PubMed 17992067
  • 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.

    PubMed 17004211
  • 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.

    PubMed 28194281

Questions about this trial

What is this clinical trial studying?

A study testing skin to skin contact in people with Parent-Child Relations, run by National Taipei University of Nursing and Health Sciences.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Paternal Attachment measured by the Paternal Attachment Questionnaire (PAQ) (time frame: the first three postpartum days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02886767, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2016.

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