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

NCT05012904 | Completed

• 1 other identifier: KAEK-792
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anxiety; Cancer; Child; Nursing; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Children's Fear Scale (CFS)

  3 MONTHS

• Heart Rate

  3 MONTHS

• Oxygen Saturation

  3 MONTHS

Study Arms (2)

Parent involvement Group

EXPERIMENTAL

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.

Behavioral: parent involvement application

Control Group

NO INTERVENTION

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.

Interventions

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.

Parent involvement Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• diagnosed with cancer,
• requiring venipuncture for blood tests,
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mehmet Akif Ersoy University: lead

Study Sites (1)

Pınar BEKAR

Burdur, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Neoplasms; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emine EFE

  Akdeniz University, Department of Child Health and Disease Nursing

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 19, 2021
• Study Start: June 1, 2021
• Primary Completion: August 10, 2021
• Study Completion: August 10, 2021
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)