- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04648787
A Study of Family-integrated Care for Reducing Uncertainty
September 27, 2023 updated by: Children's Hospital of Fudan University
A Randomized Intervention Study of Family-integrated Care for Reducing Uncertainty About Illness in Parents of Preterm Infants
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ping ge qian, bachelor
- Phone Number: 18621688920
- Email: qiangeping@163.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 201102
- Recruiting
- Children's Hospital of Fudan University
-
Contact:
- geping qian, bachelor
- Phone Number: 021 64931105
- Email: qiangeping@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 hour to 2 months (Child)
Accepts Healthy Volunteers
No
Description
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.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group: traditional nursing with family-integrated care
traditional nursing with 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.
|
Experimental: Control group: traditional nursing
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The total Scores of PPUS(Parents' Perception of Uncertainty Scale )
Time Frame: from adminssion to discharge (almostly 14 hospitalization days )
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Scores of Family satisfaction
Time Frame: The 30th day after discharge.
|
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.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Readmission rate
Time Frame: The 30th day after discharge.
|
the proportion of unplanned readmission in the total number of discharged newborns within 30 days after discharge
|
The 30th day after discharge.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: ping ge qian, bachelor, Children's Hospital of Fudan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 30, 2020
Primary Completion (Estimated)
December 31, 2023
Study Completion (Estimated)
December 31, 2023
Study Registration Dates
First Submitted
November 24, 2020
First Submitted That Met QC Criteria
November 24, 2020
First Posted (Actual)
December 2, 2020
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 27, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- gepingqian
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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