NCT06172972

Brief Summary

It is important for pediatric nurses to apply atraumatic care while providing care to children and their families. Pediatric nurses should use methods appropriate for the child's age and developmental period within the scope of atraumatic care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
219

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 15, 2023

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

November 27, 2023

Last Update Submit

December 14, 2023

Conditions

Keywords

childfearpainphlebotomydistraction methodsatraumatic care

Outcome Measures

Primary Outcomes (2)

  • Children's Fear Scale

    Children's Fear Scale was to measure fear in children who would undergo painful medical procedures

    baseline, pre-intervention and immediately after the intervention

  • Wong-Baker Faces Pain Rating Scale

    This scale is used for 3-18 age group children to describe their pain.

    immediately after the intervention

Secondary Outcomes (1)

  • Assessment of Parental Satisfaction-Visual Analog Scale

    immediately after the intervention

Study Arms (2)

Atraumatic nursing care group

EXPERIMENTAL

Before the phlebotomy, children in the intervention group were allowed to choose a distracting method (foam balloons, stress balls, musical books) to be occupied with during the procedure. It was ensured that the parent was staying with the child and that the child played with this material during the procedure (making a foam balloon, squeezing the ball with the hand in which the procedure was not carried out and reading the book with the parent

Behavioral: Atraumatic nursing care

Control group

NO INTERVENTION

The parents of the children in the control group were ensured to stay with their children during the procedure, and the child's attention was distracted by the nurse asking questions about the child's name, age, and what grade the child was in. This is one of the methods frequently used in Turkiye.

Interventions

Children in the intervention group were allowed to choose a distracting method (foam balloons, stress balls, musical books) to be occupied with during the procedure

Atraumatic nursing care group

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • being able to speak Turkish
  • being between 5-10 years of age
  • having no visual, intellectual or neurological disabilities
  • having the phlebotomy procedure carried out with a single attempt
  • not having a disease that causes chronic pain
  • being accompanied by either mother or father during the procedure
  • not taking painkillers or sedating drugs before the phlebotomy procedure

You may not qualify if:

  • being younger than 5 years or older than 10 years
  • having visual, audio, or speech impairments
  • having a disease that causes chronic pain
  • with a history of sedative and analgesic use within 24 h prior to admission
  • filling out the data collection forms incompletely

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hatice Uzşen

Samsun, Atakum, 55100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Esra Tural Büyük, PhD

    Ondokuz Mayıs University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 27, 2023

First Posted

December 15, 2023

Study Start

March 1, 2023

Primary Completion

June 1, 2023

Study Completion

June 30, 2023

Last Updated

December 15, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations