NCT04378673

Brief Summary

Children's changing emotional and physical needs, continuous, comprehensive, accessible, coordinated and family requires a centered care.Parental presence during invasive procedures is important in family-centered-care. Family-centered-care is a basic principle of pediatric nursing. It is extremely important that parents are with their children during painful procedures. Research; parents during peripheral intravenous catheterization in infancy It was planned to determine the effect of inclusion on pain and anxiety.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

May 7, 2020

Status Verified

May 1, 2020

Enrollment Period

Same day

First QC Date

May 4, 2020

Last Update Submit

May 4, 2020

Conditions

Keywords

family centered care

Outcome Measures

Primary Outcomes (1)

  • hypothesis 0

    There is no difference between the pain and anxiety levels of the children whose parents were included in the procedure during peripheral intravenous catheterization and the pain and anxiety levels of the children whose parents were only with the child during the procedure and who were not with the child during the procedure.

    March 2020-August 2020

Study Arms (3)

parental involvement group

n=46

parental presence group

n=42

parental absence group

control group, n=32

Other: not interventional

Interventions

This randomized controlled trial included data from 120 cases in the pediatric health and diseases department.

parental absence group

Eligibility Criteria

Age2 Months - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

infants and their parents were randomly sampled from the universe using a simple random sampling method, peripheral intravenous catheterization, volunteering to participate in the study, infants and parents between 1 and 24 months.

You may qualify if:

  • Children within the age group of 1-24 months Parents know Turkish language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bagcilar Training And Research Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

Study Officials

  • Nilüfer Demir, Nurse

    Bagcilar Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 7, 2020

Study Start

March 1, 2020

Primary Completion

March 1, 2020

Study Completion

August 31, 2020

Last Updated

May 7, 2020

Record last verified: 2020-05

Locations