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

Pediatric Nursing in Bagcilar Training and Research Hospital

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.

Study Overview

• Status: Unknown
• Conditions: Family Centered Care
• Intervention / Treatment: Other: not interventional

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34000
    • Bagcilar Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 2 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
parental involvement group; n=46
parental presence group; n=42
parental absence group; control group, n=32	Other: not interventional; This randomized controlled trial included data from 120 cases in the pediatric health and diseases department.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bagcilar Training and Research Hospital
• Investigators: Principal Investigator: Nilüfer Demir, Nurse, Bagcilar Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): March 1, 2020
• Study Completion (Anticipated): August 31, 2020

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): May 7, 2020
• Last Update Submitted That Met QC Criteria: May 4, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: family centered care
• Other Study ID Numbers: 16867222; Seda Caglar (Other Identifier: Istanbul University Cerrahpaşa)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No