Effects of Parent-Child Reading on Preterm Infant Stability, Parental Anxiety, and Parent-Child AttachmentNCT06854549
Impact of Picture Book Reading on Preterm Infant Stability, Parental Anxiety, and Parent-Child Attachment
A study testing Parental Reading Picture-book in people with Effects of Parent-Child Reading on Preterm Infant Stability, Parental Anxiety, and Parent-Child Attachment, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 to 37 weeks
- Conditions the study is for
- Effects of Parent-Child Reading on Preterm Infant Stability, Parental Anxiety, and Parent-Child Attachment
- What is being tested?
- Parental Reading Picture-book
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Jun 2025to 28 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 28 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm Infants:
- 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.
- Parents of Preterm Infants:
- Able to read and comprehend Chinese-language materials.
- Capable of communicating in Mandarin.
Who cannot join
- Preterm Infants:
- Presence of external ear abnormalities.
- Receiving sedatives, hypnotics, or caffeine therapy.
- Parents of Preterm Infants:
- Having auditory or speech impairments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, Beitou, 112
PEI-YU LO, +886 2-2875-7083, pylo2@vghtpe.gov.tw
About this study
Official title: The Effectiveness of Parental Reading Picture-book Intervention on Cardiopulmonary Stability, Hospitalization Anxiety and Parent-Child Attachment Relationship With Premature Infants
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.
Read the 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.
- Being tested
- Parental Reading Picture-book
- Keywords
- Reading Picture-book, Premature Infants, Hospitalization anxiety, Cardiopulmonary stability, parent-child attachment relationship
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parental Reading Picture-bookBehavioural
Also called Experimental Group
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.
| Study group | Role | What they receive |
|---|---|---|
| Preterm Infant Stability, Parental Anxiety, Parent-Child Attachment | Experimental | Not described Receives: Behavioral: Parental Reading Picture-book |
| Routine Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (2)
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.
Measured: After confirming the assigned group, and research Day 5
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.
Measured: After group assignment is confirmed ,and the fifth day of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start23 Jun 2025
- Primary completion28 Jun 2026 (estimated)
- Study completion28 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of Parent-Child Reading on Preterm Infant Stability, Parental Anxiety, and Parent-Child AttachmentStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Responsible party
- Sponsor
- Investigators
- Mei-Jy Jeng, PhD, Study chair, Taipei Veterans General Hospital, Taipei
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854549
- Sponsor's protocol ID
- 2025-02-002A
- Status last verified
- Jun 2025
- First submitted
- 25 Feb 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Parental Reading Picture-book Intervention on Cardiopulmonary Stability, Hospitalization Anxiety and Parent-Child Attachment Relationship With Premature Infants
- ClinicalTrials.gov ID
- NCT06854549
- Acronym / sponsor ID
- 2025-02-002A
- Keywords
- Reading Picture-book, Premature Infants, Hospitalization anxiety, Cardiopulmonary stability, parent-child attachment relationship
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 28 Jun 2026 (estimated)
- Study completion
- 28 Jun 2026 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm Infant Stability, Parental Anxiety, Parent-Child Attachment | Experimental | Behavioral: Parental Reading Picture-book |
| Routine Care | No intervention | –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. |
Who may qualify
- Ages
- 28 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Preterm Infants:
- Parents of Preterm Infants:
Key exclusion criteria (5 listed)
- Preterm Infants:
- Parents of Preterm Infants:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parental Reading Picture-bookAlso: Experimental GroupIn 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. | Behavioural | Preterm Infant Stability, Parental Anxiety, Parent-Child Attachment |
Primary outcome
Cardiopulmonary stability
Time frame: 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.
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.
2 secondary outcomes
Hospitalization anxiety
Time frame: After confirming the assigned group, and research Day 5
parent-to-infant attachment
Time frame: After group assignment is confirmed ,and the fifth day of the study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mei-Jy Jeng, PhD study chair
Taipei Veterans General Hospital, Taipei
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parental Reading Picture-book in people with Effects of Parent-Child Reading on Preterm Infant Stability, Parental Anxiety, and Parent-Child Attachment, run by National Yang Ming Chiao Tung University 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 30 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CHI-WEN CHEN, PhD (+886989581661 ext. 02-28267348, chiwenchen@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiopulmonary stability (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2025.