A Study of Family-integrated Care for Reducing Uncertainty

Premature Infant Clinical Trial

Official title:

A Randomized Intervention Study of Family-integrated Care for Reducing Uncertainty About Illness in Parents of Preterm Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04648787
• Other study ID #: gepingqian
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: Children's Hospital of Fudan University
• Contact: ping ge qian, bachelor
• Phone: 18621688920
• Email: qiangeping[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Hour to 2 Months

Eligibility

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.)

Related Conditions & MeSH terms

• Premature Infant

Intervention

Behavioral:
• family-integrated care
One week after admission, the parents of premature infants were informed by telephone one day in advance to enter the ward for family participation nursing, and the guidance of daily life nursing for premature infants was given on the same day, including hand hygiene, breast feeding, pacification, changing diapers, bathing and establishment of parent-child relationship. Before discharge, theparents of premature infants should be informed by telephone one day in advance to enter the ward again for family participation nursing, and half a day's guidance was given, including observation and treatment of common symptoms and signs, guidance of home safety prevention and learning to write diary of premature infants.
• traditional nursing
In hospital education: the health education manual for premature infants will be issued at the time of discharge; the patient's condition will be answered by telephone from 14:00 to 16:00 every day.

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Readmission rate	the proportion of unplanned readmission in the total number of discharged newborns within 30 days after discharge	The 30th day after discharge.
Primary	The total Scores of PPUS(Parents' Perception of Uncertainty Scale )	The scale is one of a series of uncertainty scales developed by Mishel in 1998 under the guidance of uncertainty theory of disease, which is one of the series of uncertainty scales for different groups of people. Its content includes 4 dimensions, 31 items, unclear (13 items), complexity (9 items), lack of information (5 items), and unpredictable (4 items). It includes one score from 4 dimensions adding. The score is much higher, the parents maybe feel more uncertainty.According to the response of the responders, from "completely disagree" to "completely agree", the total score is "31-155". The higher the score is, the stronger the uncertainty of the disease is. When the total score is more than 50% of the highest score, the responders are considered to have higher uncertainty of the disease.	from adminssion to discharge (almostly 14 hospitalization days )
Secondary	The Scores of Family satisfaction	Likert 5-point method was used to score, that is, 2 = very dissatisfied, 4 = dissatisfied, 6 = average, 8 = satisfied and 10 = very satisfied. The satisfaction level of each question was quantified by scoring.satisfied, satisfied and very satisfied with the score of inpatient satisfaction in the total number of discharged children.	The 30th day after discharge.