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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorNational Defense Medical Center, Taiwan

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Parents of premature infants born less than 37 weeks of age; 2. Parents of premature infants aged 20 or above and able to communicate in Mandarin and Taiwanese; 3. Parents of premature infants agree to participate in this study and sign the research consent form; 4. The child is currently in the Pediatric and Neonatal Intensive Care Center

Disqualifiers

The premature baby has congenital abnormalities or is in critical condition and cannot survive; 2. The parents cannot use mobile phones or other Internet devices; 3. The parents have a history of mental illness, intellectual disability or substance abuse.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Routine care

    Other intervention

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

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: Intelligent intervention to enhance parent-child connectionExperimental treatment 2 interventions
Group B: Routine care groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Changes in parents' sleep patterns before premature infants are discharged from hospital and in the first month after premature infants return home
2

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.

Time frame
Changes in parents' sleep details before premature infants are discharged from hospital and in the first month after premature infants return home
3

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.

Time frame
Changes in parental fatigue before premature infants were discharged from hospital and in the first month after they returned home
4

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.

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

Secondary outcomes

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Hsiang-Yun LanRecruiting Teipei, TaiwanTaiwanTaiwan

Sponsors and contacts

Click on the lead sponsor to view all of their trials.