NCT06781307

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

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

November 24, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2024

Completed
10 months until next milestone

First Posted

Study publicly available on registry

January 17, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

August 14, 2025

Status Verified

August 1, 2025

Enrollment Period

1.5 years

First QC Date

April 6, 2024

Last Update Submit

August 13, 2025

Conditions

Keywords

Sleep qualitymaternal confidencebonding

Outcome Measures

Primary Outcomes (3)

  • sleep quity Visual Analogue Scale

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

    postpartum 30 DAY

  • 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.

    postpartum 30 DAY

  • 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.

    postpartum 30 DAY

Study Arms (2)

SKIN TO SKIN

EXPERIMENTAL

Daily skin-to skin contact within 30 days of postpartum

Other: skin to skin

usual care

NO INTERVENTION

usual care

Interventions

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

SKIN TO SKIN

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jung Ti

Taichung, 412224, Taiwan

Location

Related Publications (75)

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    PMID: 35467813BACKGROUND
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    RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • TSAN-WEN HUANG, college

    Jen-Ai Hospital Institutional Review Board

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jen-Ai Hospital Principal Investigator

Study Record Dates

First Submitted

April 6, 2024

First Posted

January 17, 2025

Study Start

November 24, 2023

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

August 14, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations