Effects of Intelligent Parent-child Bonding Intervention on the Physical, Psychological and Social Health of Parents of Premature Infants During Hospitalization and Return Home

NCT06987227 | Not Yet Recruiting

• 1 other identifier: B2025050055
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study purpose is to construct and validate the effects of "intelligent parent-child bonding intervention" on the physical, psychological and social health of parents of premature infants.

Conditions

Parents of Premature Infants; Intelligent Intervention; Parent-child Connection

Keywords

physical health; psychological health; parents of premature infants; social health; Intelligent intervention; parent-child connection

Outcome Measures

Primary Outcomes (11)

• The Pittsburgh Sleep Quality Index, PSQI

  The sleep quality in the past month was measured, including seven indicators: subjective statement of sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, use of sleep aids and daytime dysfunction. Each indicator was scored between 0-3 points, and the total score ranged from 0-21 points. The higher the score, the worse the sleep quality. When the total score of sleep quality is \>5 points, it means poor sleep quality, and the total score of sleep quality is ≤5 points, it means good sleep quality.

  Changes in parents' sleep patterns before premature infants are discharged from hospital and in the first month after premature infants return home

• Actigraphy and Sleep Diary measures sleep details

  The Cole-Kripke algorithm was used to calculate the following data: (1) total sleep time: the actual time of falling asleep; (2) sleep efficiency: the percentage of time in bed compared to the actual sleep time; (3) sleep latency: the time from the time in bed to the time of falling asleep recorded by the actigraph; and (4) number of awakenings: the number of awakenings during a sleep cycle. The sleep log is recalled by the primary caregiver immediately after waking up every day, recording the sleep time and sleep status of the previous day, in order to understand the total sleep hours, the number of awakening hours/times at night, sleep efficiency, and whether there are any events that affect the mood for falling asleep, medication or physical discomfort, whether stimulants and alcohol are consumed, etc., and the sleep quality of the previous night and the degree of wakefulness when waking up are evaluated on a scale of 1 to 5 points.

  Changes in parents' sleep details before premature infants are discharged from hospital and in the first month after premature infants return home

• Brief Fatigue Inventory, BFI

  The scale is divided into two parts: the severity of fatigue and the degree of interference of fatigue on life. There are 9 questions in total, each with a score of 0 to 10 points. The total score is calculated as the average score of the first part plus the average score of the second part. The higher the score, the higher the degree of fatigue.

  Changes in parental fatigue before premature infants were discharged from hospital and in the first month after they returned home

• Perceived Stress Scale, PSS

  This scale is used to measure the stress level in an individual's life. The original scale has 14 questions, using the Likert scoring method, with a scoring method ranging from 0 (never), 1 (occasionally), 2 (sometimes), 3 (often) to 4 (always). Questions 4, 5, 6, 7, 9, 10, and 13 are reverse scored. The total score ranges from 0 to 56. The higher the score, the higher the stress level of the subject.

  Changes in parental perceived stress before premature infants were discharged from hospital and in the first month after they returned home

• Postpartum Specific Anxiety Scale

  The frequency scale used to assess the anxiety focused on mothers and infants experienced by women in the past week has a total of 12 questions, which are classified into four sub-items according to the content: maternal ability and attachment anxiety, infant safety and health anxiety, infant care anxiety, and maternal psychosocial adaptation. The Likert four-point scoring method is used, with each question ranging from 1 to 4 points, from low to high representing "never", "rarely", "often", and "always". The total score ranges from 12 to 48 points, and the higher the score, the higher the level of anxiety.

  Changes in parental anxiety before premature infants were discharged from hospital and in the first month after they returned home

• Edinburgh Postpartum Depression Scale

  There are 10 questions in total. Each item is scored from 0 to 3 points, and the total score range is 0 to 30 points. The higher the score, the more severe the depression symptoms. It is recommended that scores of ≧10 and ≧9 be used as the criteria for screening postpartum depression symptoms for fathers and mothers respectively.

  Changes in parental depression before premature infants were discharged from hospital and in the first month after they returned home

• Parental Self-efficacy scale, PSE Scale

  It is divided into three aspects: (1) Parenting role evaluation: refers to the overall feeling of one's own parenting effectiveness; (2) Parenting confidence: refers to the feeling of whether one has the confidence and competence to do the work of raising children; (3) Parenting ability: refers to the recognition and understanding of one's own ability to actually carry out the work of raising children. The scale has 20 questions, which are scored on a Likert scale, with a total score of 20-100 points. The higher the score, the higher the evaluation of one's own parenting ability. There are seven questions about parenting confidence, all of which are reverse questions.

  Changes in parental self-efficacy before premature infants were discharged from hospital and in the first month after they returned home

• Parent-infant bonding

  The scale questions adopt the Likert six-point scoring method, with each question scoring from 1 to 6 points, and the options range from "strongly disagree" to "strongly agree". Among them, only the "parenting adaptation" item adopts the reverse scoring method. The higher the score, the better the mother-infant connection in this dimension.

  Changes in parent-infant bonding before premature infants were discharged from hospital and in the first month after they returned home

• Relationship Assessment Scale, RAS

  The scale consists of 7 questions, using the Likert five-point scoring method. Each question has a score of 1 to 5. The number 1 indicates the lowest score (such as "very poor" or "unsatisfied"), and the number 5 indicates the highest score (such as "very good" or "completely satisfied"). Please answer according to your own feelings. The total score ranges from 7 to 35 points. The higher the score, the more satisfied the individual is with the relationship between husband and wife/partner.

  Changes in parental relationship before premature infants were discharged from hospital and in the first month after they returned home

• Family Resilience Assessment

  This scale has a total of 31 questions, covering three categories, namely belief system (a total of 13 questions), organizational model (a total of 9 questions) and family communication process (a total of 9 questions). It adopts Likert's five-point scoring method, "strongly agree" (5 points) and "strongly disagree" (1 point). The higher the score, the better the family resilience.

  Changes in family resilience before premature infants were discharged from hospital and in the first month after they returned home

• World Health Organization Quality of Life-BREF, WHOQOL-BREF

  There are 28 questions in total, with the past two weeks as the reference point, to assess the quality of life. The content includes four aspects: physical health, psychology, social relations and environment. The Likert five-point scoring method is adopted. The higher the score, the better the quality of life.

  Changes in quality of life before premature infants were discharged from hospital and in the first month after they returned home

Study Arms (2)

Intelligent intervention to enhance parent-child connection

EXPERIMENTAL

In addition to routine care, premature infants will receive "intelligent parent-child connection intervention" during hospitalization and continue to use it until one month after the premature infant returns home.

Behavioral: Intelligent intervention to enhance parent-child connection; Other: Routine care

Routine care group

ACTIVE COMPARATOR

Routine care is provided to premature infants during hospitalization, and general nursing guidance for premature infant discharge care is provided before discharge.

Other: Routine care

Interventions

Intelligent intervention to enhance parent-child connection BEHAVIORAL

The "Intelligent Intervention to Enhance Parent-Child Connection" support program is mainly carried out through web pages, Figma software, cloud files and official Line accounts. It can be divided into: the first stage is to provide parents with care knowledge and skills during the hospitalization of premature infants, provide parents with physical and mental support, and encourage parents to establish parent-child connections and prepare for discharge. The second stage is after discharge, continuing to provide premature infants' families with the care guidance needed to respond to the different stages of development of premature infants, including interpersonal support, sleep schedule establishment, crying comfort, premature infant nutrition and couple relationship management, etc., and continue to provide family support, answer questions and track its implementation status.

Intelligent intervention to enhance parent-child connection

Routine care OTHER

Premature infants receive routine care during their hospitalization, and general nursing guidance for premature infant discharge care is provided before discharge.

Intelligent intervention to enhance parent-child connection; Routine care group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• National Defense Medical Center, Taiwan: lead

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Lan Hsiang-Yun, A.P.

CONTACT

+886287923100 Ext. 18781; shinnylan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: May 23, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: May 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share