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A Study of Family-integrated Care for Reducing Uncertainty

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ClinicalTrials.gov Identifier: NCT04648787
Recruitment Status : Recruiting
First Posted : December 2, 2020
Last Update Posted : March 12, 2021
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Fudan University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Premature Infant Behavioral: family-integrated care Behavioral: traditional nursing Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: A Randomized Intervention Study of Family-integrated Care for Reducing Uncertainty About Illness in Parents of Preterm Infants
Actual Study Start Date : November 30, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Family Issues

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention group: traditional nursing with family-integrated care
traditional nursing with family-integrated care
 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.
Experimental: Control group: traditional nursing
traditional nursing
 Behavioral: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04648787


Contacts
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Contact: ping ge qian, bachelor 18621688920 qiangeping@163.com

Locations
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China, Shanghai
Children's Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 201102
Contact: geping qian, bachelor    64931105 ext 021    qiangeping@163.com   
Sponsors and Collaborators
Children's Hospital of Fudan University
Investigators
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Study Chair: ping ge qian, bachelor Children's Hospital of Fudan University
More Information
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Responsible Party: Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT04648787    
Other Study ID Numbers: gepingqian
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No