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

Primary Purpose

Anxiety, Cancer, Child

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
parent involvement application
Sponsored by
Mehmet Akif Ersoy University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosed with cancer,
  • requiring venipuncture for blood tests,
  • 6-12 years old,
  • ceasing analgesics 6 hours before venipuncture,
  • being in a non-terminal phase of the disease,
  • being free of neutropenia,
  • volunteering to participate in the study,
  • both parent and child being free of any health problems that prevent communication

Exclusion Criteria:

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

Sites / Locations

  • Pınar BEKAR

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Parent involvement Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
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.

Full Information

First Posted
August 13, 2021
Last Updated
January 16, 2023
Sponsor
Mehmet Akif Ersoy University
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1. Study Identification

Unique Protocol Identification Number
NCT05012904
Brief Title
Using Parental Involvement During Venipuncture to Reduce Venipuncture Pain and Anxiety in Children With Cancer
Official Title
Using Parental Involvement During Venipuncture to Reduce Venipuncture Pain and Anxiety in Children With Cancer: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
August 10, 2021 (Actual)
Study Completion Date
August 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mehmet Akif Ersoy University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Cancer, Child, Nursing, Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization was done using the closed envelope method. A total of 60 cards with 30 "parent involvement" and 30 "control" labels were placed in sealed envelopes by the nurse who conducted the study. Children were asked to choose one of these envelopes and placed in the selected group. Children were randomized into two groups: a parent involvement group (n = 30) and a control group (n = 30).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parent involvement Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
parent involvement application
Intervention Description
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 Measure Information:
Title
Wong-Baker FACES Pain Rating Scale (WB-FACES)
Description
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).
Time Frame
3 MONTHS
Secondary Outcome Measure Information:
Title
Children's Fear Scale (CFS)
Description
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).
Time Frame
3 MONTHS
Title
Heart Rate
Description
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.
Time Frame
3 MONTHS
Title
Oxygen Saturation
Description
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.
Time Frame
3 MONTHS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emine EFE
Organizational Affiliation
Akdeniz University, Department of Child Health and Disease Nursing
Official's Role
Study Director
Facility Information:
Facility Name
Pınar BEKAR
City
Burdur
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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