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

Using Parental Involvement During Venipuncture to Reduce Venipuncture Pain and Anxiety in Children With Cancer: A Randomized Controlled Study

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

Study Overview

• Status: Completed
• Conditions: Pain; Cancer; Child; Anxiety; Nursing
• Intervention / Treatment: Behavioral: parent involvement application

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Burdur, Turkey
    • Pınar BEKAR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; 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.
Experimental: Parent involvement Group; 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wong-Baker FACES Pain Rating Scale (WB-FACES)	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).	3 MONTHS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's Fear Scale (CFS)	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).	3 MONTHS
Heart Rate	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.	3 MONTHS
Oxygen Saturation	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.	3 MONTHS

Collaborators and Investigators

• Sponsor: Mehmet Akif Ersoy University
• Investigators: Study Director: Emine EFE, Akdeniz University, Department of Child Health and Disease Nursing

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): August 10, 2021
• Study Completion (Actual): August 10, 2021

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: August 13, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Estimate): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 16, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: KAEK-792

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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