The Effect of Parental Presence on Pain and Anxiety Levels During Peripheral Intravenous Catheterization in Infants
Pediatric Nursing in Bagcilar Training and Research Hospital
2 other identifiers
observational
120
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2020
Shorter than P25 for all trials
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedFirst Submitted
Initial submission to the registry
May 4, 2020
CompletedFirst Posted
Study publicly available on registry
May 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedMay 7, 2020
May 1, 2020
Same day
May 4, 2020
May 4, 2020
Conditions
Keywords
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
Interventions
This randomized controlled trial included data from 120 cases in the pediatric health and diseases department.
Eligibility Criteria
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)
Study Officials
- PRINCIPAL INVESTIGATOR
Nilüfer Demir, Nurse
Bagcilar Training and Research Hospital
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