The Effect of Parental Presence on Pain and Anxiety Levels During Peripheral Intravenous Catheterization in Infants

Family Centered Care Clinical Trial

Official title:

Pediatric Nursing in Bagcilar Training and Research Hospital

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04378673
• Other study ID #: 16867222
• Secondary ID: Seda Caglar
• Status: Active, not recruiting
• Start date: March 1, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: May 2020
• Source: Bagcilar Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This randomized controlled trial included data from 120 cases in the Pediatric Health and Diseases Department of Istanbul, during March 2020-August 2020 (parental involvement group, n = 46; parental presence group, n = 42; parental absence group, n = 32). Information form, State-Trait Anxiety Inventory and FLACC scale were used to collect data.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: August 31, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 24 Months

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Family Centered Care

Intervention

Other:
• not interventional
This randomized controlled trial included data from 120 cases in the pediatric health and diseases department.

Locations

Country	Name	City	State
Turkey	Bagcilar Training And Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bagcilar Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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