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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05012904
• Other study ID #: KAEK-792
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: August 10, 2021

Study information

• Verified date: January 2023
• Source: Mehmet Akif Ersoy University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 10, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Cancer
• Child
• Nursing
• Pain

Intervention

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.

Locations

Country	Name	City	State
Turkey	Pinar BEKAR	Burdur

Sponsors (1)

Lead Sponsor	Collaborator
Mehmet Akif Ersoy University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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