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.
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.
- Conditions
- Parent-Child Relations
- 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 group | Role | What they receive |
|---|---|---|
| skin-to-skin contact (SSC) | Experimental | Experimental: a daily skin-to-skin contact (SSC) at least 15 minutes in length Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted1 Sep 2016 (estimated)
- Study startDec 2012
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Er-Mei Chen, National Taipei University of Nursing and Health Sciences
- Investigators
- Chien-Huei Kao, PhD, Study director, National Taipei University of Nursing and Health Sciences
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 27476026Cong 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 25988992Nimbalkar 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 25509971Moore 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 17636727Cho 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 26975461Stevens 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 24720501Conde-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 21412879Lee 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 17992067Wang 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 17004211Chen 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Father-Neonate Skin-to-Skin Contact on Attachment: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02886767
- Acronym / sponsor ID
- FNSSC / CGH-P101077
- Conditions
- Parent-Child Relations
- Keywords
- skin to skin contact
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 1 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| skin-to-skin contact (SSC) | Experimental | Other: skin to skin contactExperimental: a daily skin-to-skin contact (SSC) at least 15 minutes in length |
| Control: hospital routine care | No intervention | –As the hospital routine. Allow the father to visit the neonate, touching the neonate |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- the neonate gestational age less than 37 weeks;
- the neonate vital signs unstable; and
- the neonate with congenital abnormalities or diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin to skin contactThe 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. | Other | skin-to-skin contact (SSC) |
Primary outcome
Paternal Attachment measured by the Paternal Attachment Questionnaire (PAQ)
Time frame: the first three postpartum days
measured by the Paternal Attachment Questionnaire (PAQ)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
- Results publication: PubMed 27476026Shorey 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.
- Results publication: PubMed 25988992Cong 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.
- Results publication: PubMed 25509971Nimbalkar 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.
- Results publication: PubMed 17636727Moore 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.
- Results publication: PubMed 26975461Cho 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.
- Results publication: PubMed 24720501Stevens 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.
- Results publication: PubMed 21412879Conde-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.
- Results publication: PubMed 17992067Lee 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.
- Results publication: PubMed 17004211Wang 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.
- Derived from this study: PubMed 28194281Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chien-Huei Kao, PhD study director
National Taipei University of Nursing and Health Sciences
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.