Clinical trial NCT05012904: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Cancer
Child
Nursing
Pain
Lead sponsor: Mehmet Akif Ersoy University
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Wong-Baker FACES Pain Rating Scale (WB-FACES)
timeFrame: 3 MONTHS
Secondary outcomes:
measure: Children's Fear Scale (CFS)
timeFrame: 3 MONTHS
measure: Heart Rate
timeFrame: 3 MONTHS
measure: Oxygen Saturation
timeFrame: 3 MONTHS
Other outcomes:
Locations:
city: Burdur
country: Turkey
facility: Pınar BEKAR
Study officials:
affiliation: Akdeniz University, Department of Child Health and Disease Nursing
name: Emine EFE
role: STUDY_DIRECTOR
References: