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Completed

NCT Number: NCT05012904

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

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

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pınar BEKAR

Burdur, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

parent involvement application

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.

Primary outcomes

  1. Wong-Baker FACES Pain Rating Scale (WB-FACES)

    Time frame: 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 outcomes

  1. Children's Fear Scale (CFS)

    Time frame: 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).

  2. Heart Rate

    Time frame: 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.

  3. Oxygen Saturation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mehmet Akif Ersoy University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 19, 2021
Registry last updated
Jan 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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