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AttachmentNCT06781307

Effects of Mother-infant Skin-to-skin Contact in Postpartum Women

A study testing skin to skin in people with Attachment, run by Jen-Ai Hospital Institutional Review Board at 1 site in Taiwan.

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

When a newborn is delivered in good physiological condition, immediate skin-to-skin contact with the mother is required. Skin-to-skin contact has a wide range of benefits for both mother and baby. The implementation time can start from the birth of the newborn and continue until thereafter. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Attachment
What is being tested?
skin to skin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteTaiwan
Study dates
24 Nov 2023to 31 May 2025
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 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Vaginal delivery to primiparous women
  • Full-term delivery over 37 weeks
  • The pregnancy and delivery process are low-risk cases
  • Can listen, listen, read and write Chinese
  • Agree to participate in this study
  • No mental condition
Show all 9Show fewer
  • The newborn's vital signs are stable after birth
  • The body appearance is normal after birth and there are no other complications.
  • Can be discharged from hospital together with mother

Who cannot join

  • (1)Transfer of newborn to sick nursery after birth

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Jung Ti

    Taichung, 412224

Other trials in Taiwan

About this study

Official title: Department of Nurse-Midwifery and Women Health Graduate Institute of Nurse-Nurse-Midwifery

When a newborn is delivered in good physiological condition, immediate skin-to-skin contact with the mother is required. Skin-to-skin contact has a wide range of benefits for both mother and baby. The implementation time can start from the birth of the newborn and continue until thereafter. There are benefits both in the short and long term, such as physiological stability, parent-child relationship development, and stability of children's behavioral development. There were 108 cases admitted and the attrition rate was 10%. Therefore, the total number of cases admitted was 118, divided into experimental groups and control groups, and intervention measures were implemented in the experimental group. From the 1st to the 30th day after delivery, there is 1 hour of skin-to-skin contact between mother and baby every day. Fill out the Sleep Quality Visual Analog Scale, Maternal Confidence Scale, and Mother-Infant Bonding Scale on the day after delivery and at one month later.

Read the detailed description

According to the World Health Organization's clinical care guidelines for childbirth, neonatal care in the third stage of labor: When the newborn is delivered in good physiological condition, it needs to have skin-to-skin contact with the mother immediately. Skin-to-skin contact has extensive benefits for both mother and baby. The implementation time can start from the birth of the newborn and continue thereafter. It has benefits in both the short and long term, such as physiological stability, parent-child relationship development, and child behavioral development stability, etc. Therefore, this study was designed as a quasi-experimental study, using a random method to accept cases. The number of admitted cases was 128, and the attrition rate was 10%. Therefore, the total number of admitted cases was 140, divided into experimental groups and control groups, with intervention measures for the experimental group, and intervention measures. From the 1st to 30th day after delivery, there was 1 hour of skin-to-skin contact between mother and baby every day. On the postpartum day and at the full moon, the sleep quality visual analog scale, maternal confidence scale, and mother-infant bonding scale were filled in, and the statistical method was chi-square. Test, independent sample t test, sample t test, Pearson correlation test, simple regression analysis of the relationship between independent variables and dependent variables and the difference between the experimental group and the control group.

Conditions
Attachment
Being tested
skin to skin
Keywords
Sleep quality, maternal confidence, bonding
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

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

  • skin to skinOther

    Intervention measures include 1 hour of skin-to-skin contact between mother and baby every day from day 1 to day 30 postpartum.

Study groups in NCT06781307
Study groupRoleWhat they receive
SKIN TO SKINExperimentalDaily skin-to skin contact within 30 days of postpartum
Receives: Other: skin to skin
usual careNo interventionusual care

What is being measured

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

  1. sleep quity Visual Analogue Scale

    A score of 0 is the worst sleep quality A score Score 10 points for best sleep quality

    Measured: postpartum 30 DAY

  2. maternal confidence scale

    A score of 0 means never A score of 1 means very little A score of 2 means sometimes A score of 3 mean often A score of 4 mean always The higher the score, the higher the confidence in parenting.

    Measured: postpartum 30 DAY

  3. bonding scale

    A score of 1 represents strongly disagree, A score of 2 means disagreement, A score of 3 means somewhat disagreeing, A score of 4 means somewhat agree, A score of 5 means agreement A score of 6 means strongly agree The higher the score, the closer the emotional connection between mother and baby.

    Measured: postpartum 30 DAY

Timeline

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

  1. First posted17 Jan 2025
  2. Study start24 Nov 2023
  3. Primary completion31 May 2025
  4. Study completion31 May 2025

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
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06781307
Sponsor's protocol ID
JenAiH
Status last verified
Aug 2025
First submitted
6 Apr 2024
Last updated
14 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • World Health Organization/UNICEF.(2018). Monitoring the situation of children and Women:Breastfeeding.

  • WHO recommendations on maternal and newborn care for a positive postnatal experience [Internet]. Geneva: World Health Organization; 2022. Available from http://www.ncbi.nlm.nih.gov/books/NBK579657/

    PubMed 35467813

  • UNICEF(2022) /Too few children benefit from recommended breastfeeding practices

  • Afolabi O, Bunce L, Lusher J, Banbury S. Postnatal depression, maternal-infant bonding and social support: a cross-cultural comparison of Nigerian and British mothers. J Ment Health. 2020 Aug;29(4):424-430. doi: 10.1080/09638237.2017.1340595. Epub 2017 Jul 4.

    PubMed 28675061

  • Aghdas K, Talat K, Sepideh B. Effect of immediate and continuous mother-infant skin-to-skin contact on breastfeeding self-efficacy of primiparous women: a randomised control trial. Women Birth. 2014 Mar;27(1):37-40. doi: 10.1016/j.wombi.2013.09.004. Epub 2013 Nov 9.

    PubMed 24216342

  • Altemus M, Deuster PA, Galliven E, Carter CS, Gold PW. Suppression of hypothalmic-pituitary-adrenal axis responses to stress in lactating women. J Clin Endocrinol Metab. 1995 Oct;80(10):2954-9. doi: 10.1210/jcem.80.10.7559880.

    PubMed 7559880

  • Almutairi WM. Literature Review: Physiological Management for Preventing Postpartum Hemorrhage. Healthcare (Basel). 2021 May 31;9(6):658. doi: 10.3390/healthcare9060658.

    PubMed 34073073

  • Badr LK. Further psychometric testing and use of the Maternal Confidence Questionnaire. Issues Compr Pediatr Nurs. 2005 Jul-Sep;28(3):163-74. doi: 10.1080/01460860500227572.

    PubMed 16251162

  • Balatero JS, Spilker AF, McNiesh SG. Barriers to Skin-to-Skin Contact after Cesarean Birth. MCN Am J Matern Child Nurs. 2019 May/Jun;44(3):137-143. doi: 10.1097/NMC.0000000000000521.

    PubMed 31033584

  • Beato AF, Albuquerque S, Komurcu Akik B, da Costa LP, Salvador A. Do Maternal Self-Criticism and Symptoms of Postpartum Depression and Anxiety Mediate the Effect of History of Depression and Anxiety Symptoms on Mother-Infant Bonding? Parallel-Serial Mediation Models. Front Psychol. 2022 May 26;13:858356. doi: 10.3389/fpsyg.2022.858356. eCollection 2022.

    PubMed 35693484

  • Bicking Kinsey C, Hupcey JE. State of the science of maternal-infant bonding: a principle-based concept analysis. Midwifery. 2013 Dec;29(12):1314-20. doi: 10.1016/j.midw.2012.12.019. Epub 2013 Feb 27.

    PubMed 23452661

  • Bieleninik L, Lutkiewicz K, Cieslak M, Preis-Orlikowska J, Bidzan M. Associations of Maternal-Infant Bonding with Maternal Mental Health, Infant's Characteristics and Socio-Demographical Variables in the Early Postpartum Period: A Cross-Sectional Study. Int J Environ Res Public Health. 2021 Aug 12;18(16):8517. doi: 10.3390/ijerph18168517.

    PubMed 34444265

  • Boonstra TW, Stins JF, Daffertshofer A, Beek PJ. Effects of sleep deprivation on neural functioning: an integrative review. Cell Mol Life Sci. 2007 Apr;64(7-8):934-46. doi: 10.1007/s00018-007-6457-8.

    PubMed 17347797

  • Brimdyr K, Stevens J, Svensson K, Blair A, Turner-Maffei C, Grady J, Bastarache L, Al Alfy A, Crenshaw JT, Giugliani ERJ, Ewald U, Haider R, Jonas W, Kagawa M, Lillieskold S, Maastrup R, Sinclair R, Swift E, Takahashi Y, Cadwell K. Skin-to-skin contact after birth: Developing a research and practice guideline. Acta Paediatr. 2023 Aug;112(8):1633-1643. doi: 10.1111/apa.16842. Epub 2023 May 24.

    PubMed 37166443

  • Bystrova K, Matthiesen AS, Vorontsov I, Widstrom AM, Ransjo-Arvidson AB, Uvnas-Moberg K. Maternal axillar and breast temperature after giving birth: effects of delivery ward practices and relation to infant temperature. Birth. 2007 Dec;34(4):291-300. doi: 10.1111/j.1523-536X.2007.00187.x.

    PubMed 18021144

Questions about this trial

What is this clinical trial studying?

A study testing skin to skin in people with Attachment, run by Jen-Ai Hospital Institutional Review Board at 1 site in Taiwan.

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 9 inclusion and 1 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 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

sleep quity Visual Analogue Scale (time frame: postpartum 30 DAY). The study lists 3 primary outcomes in all. 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 NCT06781307, which also lists 75 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 14 Aug 2025.

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