A Study of Family-integrated Care for Reducing Uncertainty
A Randomized Intervention Study of Family-integrated Care for Reducing Uncertainty About Illness in Parents of Preterm Infants
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2020
CompletedStudy Start
First participant enrolled
November 30, 2020
CompletedFirst Posted
Study publicly available on registry
December 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedSeptember 28, 2023
September 1, 2023
3.1 years
November 24, 2020
September 27, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
The Scores of Family satisfaction
The 30th day after discharge.
Other Outcomes (1)
Readmission rate
The 30th day after discharge.
Study Arms (2)
Intervention group: traditional nursing with family-integrated care
EXPERIMENTALtraditional nursing with family-integrated care
Control group: traditional nursing
EXPERIMENTALtraditional nursing
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Children:
- 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
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
ping ge qian, bachelor
Children's Hospital of Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2020
First Posted
December 2, 2020
Study Start
November 30, 2020
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
September 28, 2023
Record last verified: 2023-09