About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Born between 28+0 and 36+6 weeks of gestation.
Transferred out of the incubator as per medical advice.
Passed the newborn hearing screening in both ears.
Able to read and comprehend Chinese-language materials.
Disqualifiers
Presence of external ear abnormalities.
Receiving sedatives, hypnotics, or caffeine therapy.
Having auditory or speech impairments.
Trial design
Parallel
Treatments tested in this trial
Parental Reading Picture-book
BehavioralIn 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.
Treatment groups
Trial outcomes
Primary outcomes
Cardiopulmonary stability
The intervention period in this study begins on the second day after the preterm infant is transferred out of the incubator and concludes on the fifth day. Data collection occurs at 24 time points throughout the study. Physiological indicators, including heart rate, respiratory rate, oxygen saturation, and heart rate variability, are recorded 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
Hospitalization anxiety
After group assignment is confirmed, the parents of the participants complete the pretest questionnaire of the State-Trait Anxiety Inventory (STAI). On the fifth day of the study, they complete the posttest questionnaire of the State Anxiety Scale. The STAI consists of 20 items, scored using a 4-point Likert scale: 1 ("Not at all"), 2 ("Somewhat"), 3 ("Moderately so"), and 4 ("Very much so"). The total score is the sum of all item scores, with higher scores indicating higher levels of anxiety. A total score of 20-39 indicates mild anxiety, 40-59 indicates moderate anxiety, and 60 or above indicates severe anxiety.
parent-to-infant attachment
After group assignment is confirmed, the parents of the participants complete the pretest questionnaire of the "Maternal Attachment Inventory". On the fifth day of the study, they complete the posttest questionnaire of the "Maternal Attachment Inventory(MAI)". The MAI consists of 22 items, scored using a 4-point scale ranging from 1 ("Almost never") to 4 ("Almost always"). The total score ranges from 22 to 88, with higher scores indicating a stronger mother-infant attachment.
Sponsors and contacts
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National Yang Ming Chiao Tung University
Lead sponsor
Taipei Veterans General Hospital, Taiwan
Collaborator