Clinical trial NCT04648787: A Study of Family-integrated Care for Reducing Uncertainty
Official title: A Randomized Intervention Study of Family-integrated Care for Reducing Uncertainty About Illness in Parents of Preterm Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature Infant
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To explore the intervention effect of family participatory nursing on the uncertainty of illness of parents of hospitalized premature infants, and to evaluate the uncertainty level of parents of premature infants in different stages. The study will be described the feeling of parents of premature infants after family participation nursing through interview. We will provide support for families of premature infants, and then to provide support for growth and development of premature infants.

Detailed description: Most of the current management mode of restricting or forbidding visiting in neonatology, parents can not establish the perception of premature infants and lack of communication with medical staff, which will lead to negative emotions represented by uncertainty of disease.The research on uncertainty of disease started late in China, mostly used in tumor, epilepsy and congenital heart disease. The research on parents of NICU children mostly focused on the analysis of influencing factors of uncertainty of disease, lacking intervention research, and the measures were only the information support mode based on health education. We want to explore the intervention effect of family participatory nursing on the uncertainty of illness of parents of hospitalized premature infants, and to evaluate the uncertainty level of parents of premature infants in different stages. Describe the feeling of parents of premature infants after family participation nursing through interview. We will provide support for families of premature infants, and then to provide support for growth and development of premature infants.

Eligibility criteria: Inclusion Criteria:

Children:

* 32 weeks \< gestational age \< 37 weeks
* Birth weight ≤ 2500g
* Apgar score \> 7
* Transferred to our hospital within 8 hours after birth

Parents:

* Have normal communication ability and understanding ability
* Agreed to participate in this study

Exclusion Criteria:

Children:

-With serious life-threatening diseases, the neonatal critical cases score (discussion draft) was rated as "extremely critical"

Parents:

-There are serious diseases or major negative events in the family (such as traffic accidents, natural disasters, etc.)

Primary outcomes:
measure: The total Scores of PPUS(Parents' Perception of Uncertainty Scale )
timeFrame: from adminssion to discharge (almostly 14 hospitalization days )
Secondary outcomes:
measure: The Scores of Family satisfaction
timeFrame: The 30th day after discharge.
Other outcomes:
measure: Readmission rate
timeFrame: The 30th day after discharge.
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: ping ge qian, bachelor
role: STUDY_CHAIR
References: