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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05592210
Other study ID # preterm infant(PES)
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 16, 2023
Est. completion date April 1, 2024

Study information

Verified date May 2023
Source Sun Yat-sen University
Contact Wei Xia, PhD
Phone +86-18823359471
Email xiaw23@mail.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to investigate the parenting stress, parenting self-efficacy and dyadic coping of preterm parents and explore the influence and pathway analysis of dyadic coping between parenting stress and parenting self-efficacy.


Description:

For now, there is a lack of investigation and research on parenting stress, parenting self-efficacy and dyadic coping of co-parenting for discharged premature infants in the literature, and the mediating effect of dyadic coping between parenting stress and parenting self-efficacy of preterm parents has not been verified yet. This study aims to provide a theoretical basis for effective intervention for preterm parents with high parenting pressure and insufficient parenting self-efficacy in clinical work.


Recruitment information / eligibility

Status Recruiting
Enrollment 308
Est. completion date April 1, 2024
Est. primary completion date December 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria for parents - Parents of hospitalized preterm infants with a gestational age of less than 37 weeks; - Both parents are at least 18 years old; - Able to read and communicate in Chinese, able to complete the questionnaire independently or with the help of the investigator; Inclusion criteria for Infants - Gestational age less than 37 weeks; - admitted to the NU or NICU and discharged after treatment Exclusion criteria for parents - Single-parent family; - Parents diagnosed with severe anxiety and depression; Exclusion criteria for Infants - for birth defects cannot be cured and affect the quality of life; - infants who were given up treatment due to illness or family reasons; - transferred or death;

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaires
Participants will be asked to fill out the the Demographic Information Sheet, Karitane parenting confidence scale, Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU) and Dyadic Coping Inventory.

Locations

Country Name City State
China Peking University Shenzhen Hosipital Shenzhen

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Karitane parenting confidence scale The Karitane parenting confidence scale will measure the Parenting Self-efficacy of preterm parents. The scale adopts a Likert 4-level scoring method, with 0 representing hardly ever and 3 representing most of the time. The higher the scores of each dimension and the total score, the higher the self-efficacy of the Parenting Self-efficacy of preterm parents. baseline
Primary Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU) The Parenting Stress of preterm parents will be measured by Parental Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU). The scale was scored from 1(not experient) to 5(extremely stressful) points, and the higher the score, the higher the feeling of parenting stress. baseline
Primary Dyadic Coping Inventory The Dyadic Coping of preterm parents will be measured by Dyadic Coping Inventory. The total score ranges from 36 to 180.. The higher the score, the more supportive behaviors the partner gives. baseline
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