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

NCT ID: NCT05012904

Last Updated: 2023-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2021-08-10

Brief Summary

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

Detailed Description

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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.

Conditions

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Anxiety Cancer Child Nursing Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

parent involvement application

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mehmet Akif Ersoy University

OTHER

Sponsor Role lead

Responsible Party

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Pınar BEKAR

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emine EFE

Role: STUDY_DIRECTOR

Akdeniz University, Department of Child Health and Disease Nursing

Locations

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Pınar BEKAR

Burdur, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KAEK-792

Identifier Type: -

Identifier Source: org_study_id

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