Clinical trial NCT06854549: Impact of Picture Book Reading on Preterm Infant Stability, Parental Anxiety, and Parent-Child Attachment
Official title: The Effectiveness of Parental Reading Picture-book Intervention on Cardiopulmonary Stability, Hospitalization Anxiety and Parent-Child Attachment Relationship With Premature Infants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Effects of Parent-Child Reading on Preterm Infant Stability, Parental Anxiety, and Parent-Child Attachment
Keywords: Reading Picture-book
Premature Infants
Hospitalization anxiety
Cardiopulmonary stability
parent-child attachment relationship
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
Collaborators: name: Taipei Veterans General Hospital, Taiwan
First posted: 2025-03-03
Enrollment: 88
Sex: ALL
Minimum age (years): 28
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cardiopulmonary stability
timeFrame: ecorded at 14:00, 14:10, and 14:20 on the second to fourth days after incubator transfer, as well as at 14:20 on the fifth day.
Secondary outcomes:
measure: Hospitalization anxiety
timeFrame: After confirming the assigned group, and research Day 5
measure: parent-to-infant attachment
timeFrame: After group assignment is confirmed ,and the fifth day of the study.
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Veterans General Hospital, Taipei
name: Mei-Jy Jeng, PhD
role: STUDY_CHAIR
References: