Using Parental Involvement During Venipuncture to Reduce Venipuncture Pain and Anxiety in Children With Cancer

Not Applicable

Completed

• Conditions: Cancer; Child; Pain; Anxiety; Nursing
• Interventions: Behavioral: parent involvement application

• Registration Number: NCT05012904
• Lead Sponsor: Mehmet Akif Ersoy University

Brief Summary

This study aims to determine whether parental involvement during venipuncture reduces venipuncture pain and anxiety in children with cancer.

Detailed Description

This was a randomized controlled trial with parallel groups in which 60 children with cancer aged 6-12 were randomly allocated to a control group (n = 30) and a parent involvement group (n = 30). Each child's anxiety was evaluated by the child using the Children's Fear Scale before, during venipuncture, and each child's pain during the procedure was evaluated by the child using the Wong-Baker Faces Pain Rating Scale. Each child's heart rate and oxygen saturation were measured with a pulse oximeter device before, during the procedure.

Control group (n = 30): Routine venipuncture procedure was applied to the control group. The parent was present in the child's room but did not participate in the procedure.

Parent involvement group (n = 30): A parent was involved in the procedure. The parent held the children in their arms and holding the extremity from which the blood was drawn, holding the hands of children and communicating with their children in the child's room, and in this way the parent was involved in the procedure.

Study Timeline

• Study Start: 2021-06-01
• Primary Completion: 2021-08-10
• Study Completion: 2021-08-10
• Study First Submitted: 2021-08-13
• Study First Submitted QC: 2021-08-13
• Study First Posted: 2021-08-19
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• diagnosed with cancer,
• requiring venipuncture for blood tests,
• 6-12 years old,
• not having taken any analgesics in the 6 hours before venipuncture,
• being in a non-terminal phase of the disease,
• absence of neutropenia,
• volunteering to participate in the study,
• the absence of any health problems that prevent communication in the parent or the child

Exclusion Criteria

• reporting pain for another reason in the time of the venipuncture
• having another chronic disease besides cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parent involvement Group	parent involvement application	A parent was involved in the procedure. The parent held the children in their arms and holding the extremity from which the blood was drawn, holding the hands of children and communicating with their children in the child's room, and in this way the parent was involved in the procedure.

Primary Outcome Measures

Name	Time	Method
Wong-Baker FACES Pain Rating Scale (WB-FACES)	3 MONTHS	The Wong-Baker Faces Pain Rating Scale (WB-FACES) is used to evaluate pain levels in children. This numeric rating scale ranges from 0 to 10 and is represented by faces that display emotions ranging from smiling (0 = very happy or no pain) to crying (10 = the worst pain).

Secondary Outcome Measures

Name	Time	Method
Children's Fear Scale (CFS)	3 MONTHS	The Children's Fear Scale (CFS) is used to evaluate anxiety levels in children. It consists of five facial expressions representing a range from no anxiety (0) to severe anxiety (4).
Heart Rate	3 MONTHS	The heart rate and oxygen saturation values of the children in both groups were measured and recorded by the researcher before the procedure, during the procedure using a pulse oximeter device.
Oxygen Saturation	3 MONTHS	The heart rate and oxygen saturation values of the children in both groups were measured and recorded by the researcher before the procedure, during the procedure using a pulse oximeter device.

Trial Locations

Locations (1)

Pınar BEKAR; 🇹🇷 Burdur, Turkey