Impact of Picture Book Reading on Preterm Infant Stability, Parental Anxiety, and Parent-Child Attachment

NCT ID: NCT06854549

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-23

Study Completion Date

2026-06-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study investigates the effects of a parent-child picture book reading intervention on the cardiopulmonary stability of preterm infants, parental anxiety, and parent-child attachment. A randomized controlled trial will be conducted in a neonatal intensive care unit (NICU) and neonatal intermediate care unit in northern Taiwan. A total of 88 preterm infants and their parents will be randomly assigned to an intervention or control group. Parents in the intervention group will read picture books to their infants from a corrected gestational age of 28 weeks to 36 weeks and 6 days. Physiological data (heart rate, respiratory rate, oxygen saturation, and heart rate variability) and parental anxiety levels will be assessed at multiple time points. The study aims to determine whether this intervention improves infant stability, reduces parental anxiety, and enhances parent-child attachment, contributing to improved neonatal care practices.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Background The birth and survival rates of preterm infants in our country have significantly improved. However, due to the immaturity of their autonomic nervous systems, preterm infants are at risk of complications stemming from unstable vital signs. This instability often induces anxiety in parents, which can further impact their psychological adjustment and hinder the establishment of a secure parent-child attachment. Consequently, this study aims to develop a systematic intervention program using picture book reading to improve the cardiopulmonary stability of preterm infants, alleviate parental anxiety, and enhance the parent-child bond.

Objective To evaluate the effects of a parent-child picture book reading intervention on the cardiopulmonary stability of preterm infants, parental anxiety during hospitalization, and the parent-child attachment relationship.

Methods This study will employ a randomized controlled trial (RCT) design. Participants will include preterm infants and at least one parent from the neonatal intensive care unit (NICU) and neonatal intermediate care unit of a medical center in northern Taiwan. A total of 88 pairs of preterm infants and their parents will be recruited and randomly assigned to either the experimental or control group. The intervention consists of parents reading picture books to their preterm infants, starting at a corrected gestational age of 28 weeks and continuing until 36 weeks and 6 days. Data will be collected at multiple time points, including measurements of heart rate, respiratory rate, oxygen saturation, and heart rate variability. Subjective data will be gathered using the State-Trait Anxiety Inventory (STAI) and the Parent-Child Attachment Scale, while objective data will be recorded via physiological monitors and heart rate variability analyzers. Statistical analyses, including independent samples t-tests, repeated measures ANOVA, and generalized estimating equations (GEE), will be performed to compare the intervention's effectiveness.

Project Goal To develop and evaluate the effectiveness of a parent-child picture book reading intervention program for preterm infants. The findings aim to inform pediatric clinical care practices and support the health and well-being of families with preterm infants.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Effects of Parent-Child Reading on Preterm Infant Stability, Parental Anxiety, and Parent-Child Attachment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Preterm Infant Stability, Parental Anxiety, Parent-Child Attachment

Group Type EXPERIMENTAL

Parental Reading Picture-book

Intervention Type BEHAVIORAL

In addition to receiving routine care, the experimental group will be given the "Reading Picture Books from Scratch" educational booklet once the preterm infant is removed from the incubator, the group assignment is confirmed, and participation in the study is verified. They will then undergo the "Picture Book Reading Intervention." This intervention targets the preterm infant and one of the parents. It involves reading picture books from the second to the fourth day after the infant is removed from the incubator, during the visiting period from 14:10 to 14:20.

Routine Care

The control group in this study will receive standard routine care in the neonatal ward and intensive care unit of a medical center in Northern Taiwan. Routine clinical care involves one parent visiting the preterm infant during visiting hours. After the physician or nurse explains the infant's current condition to the parent, the parent is allowed to visit the preterm infant freely for half an hour. On the day of discharge, control group participants will receive the same educational booklet titled "Reading Picture Books from Scratch" as the experimental group. The benefits and importance of picture book reading interventions will be explained to them, and parents will be encouraged to use the gifted picture books for reading activities at home.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Parental Reading Picture-book

In addition to receiving routine care, the experimental group will be given the "Reading Picture Books from Scratch" educational booklet once the preterm infant is removed from the incubator, the group assignment is confirmed, and participation in the study is verified. They will then undergo the "Picture Book Reading Intervention." This intervention targets the preterm infant and one of the parents. It involves reading picture books from the second to the fourth day after the infant is removed from the incubator, during the visiting period from 14:10 to 14:20.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Experimental Group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Preterm Infants:

1. Born between 28+0 and 36+6 weeks of gestation.
2. Transferred out of the incubator as per medical advice.
3. Passed the newborn hearing screening in both ears.
* Parents of Preterm Infants:

1. Able to read and comprehend Chinese-language materials.
2. Capable of communicating in Mandarin.

Exclusion Criteria

* Preterm Infants:

1. Presence of external ear abnormalities.
2. Receiving sedatives, hypnotics, or caffeine therapy.
* Parents of Preterm Infants:

1. Having auditory or speech impairments.
Minimum Eligible Age

28 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role collaborator

National Yang Ming Chiao Tung University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mei-Jy Jeng, PhD

Role: STUDY_CHAIR

Taipei Veterans General Hospital, Taipei

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Taipei Veterans General Hospital

Taipei, Beitou, Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

CHI-WEN CHEN, PhD

Role: CONTACT

+886989581661 ext. 02-28267348

PEI-YU LO

Role: CONTACT

+886-2-28757083

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

PEI-YU LO

Role: primary

+886 2-2875-7083

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2025-02-002A

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Newborn Nursery Reach Out and Read
NCT04147429 COMPLETED NA