The Effect Of Diverting The Children's Attention To A Different Point During Phlebotomy

The Effect Of Diverting The Children's Attention To A Different Point During Phlebotomy On Pain And Anxiety

This study aimed to investigate the effect of diverting the children's attention to a different point during phlebotomy which is an invasive procedure with acute pain. This is a randomized controlled experimental study. The study was conducted with two groups: the intervention group (n=127) and the control group (n=129). The control group was applied to standard phlebotomy procedures. In contrast, the intervention group had a piece of equipment that looks like a blood tube in front of them during the phlebotomy process to divert their attention from the phlebotomy process to the equipment.

Study Overview

• Status: Completed
• Conditions: Pain and Anxiety of Children During Phlebotomy
• Intervention / Treatment: Device: Equipment to divert the focus of children

Detailed Description

The equipment used for the intervention group was designed and developed by the researchers with the project support of TÜBİTAK BİDEB 2209A in 2016. It is an equipment that looks like a blood tube with a fixed arm on the right and a moving arm on the left with a total height of 80 cm. It has some answers to common questions of parents as well as the key concerns of the children " Will it hurt me?"

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Manavgat
    • Antalya, Manavgat, Turkey, 07600
      • Manavgat State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• making a request for the phlebotomy
• being in the 7-12 age group
• having the consent of the parent
• willing to participate in the research
• with the history of invasive procedure
• not using any medication with analgesic effect in the last 12 hours
• without any communication barriers of either child or the parent
• with a normal level of consciousness during the process
• without the history of passing out during the phlebotomy

Exclusion Criteria:

• not being in the 7-12 age group
• not having the consent of the parent
• not willing to participate in the research
• without the history of invasive procedure
• had medication with analgesic effect in the last 12 hours
• with communication barriers of either child or the parent
• with an abnormal level of consciousness during the process
• with the history of passing out during the phlebotomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Equipment Intervention Group; The intervention group had equipment that looks like a blood tube in front of them during the blood collection process to divert their attention from the blood collection process to the equipment. This equipment was with a fixed arm on the right and a moving arm on the left with a total height of 80 cm as well as a red light-emitting diode(LED) to stimulate the blood collection. It had some answers to common questions of parents as well as the key concerns of the children like " Will it hurt me?". The equipment was made a musical device by loading the most popular children's songs into its database.	Device: Equipment to divert the focus of children; The equipment was placed in an area where the children would be able to see easily during the blood collection process. It was turned on as soon as the children sat on to the chair where the process would take place to divert the focus of the children at the equipment.
NO_INTERVENTION: No Intervention Group; Standard blood collection procedures were applied to the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Children's Anxiety Level Change	Children's Fear Scale is an instrument with five different face images changing from neutral (0= no fear) to most scared (4= with the most fear) to evaluate the scare level of the children during the procedure.	Twice ( Immediately after the procedure and 14 days after the procedure)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revised Face Pain Scale (FPS-R)	The FPS-R is a scale to measure how children feel in their inner world than how their faces look. It is designed on the widely accepted 0-to-10 metric according to the chosen face. "0" equals "No pain" and "10" equals "Very much pain."	Twice ( During the procedure and 5-10 minutes after the procedure)

Collaborators and Investigators

• Sponsor: Afyonkarahisar Health Sciences University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 18, 2019
• Primary Completion (ACTUAL): March 28, 2019
• Study Completion (ACTUAL): March 28, 2019

Study Registration Dates

• First Submitted: August 8, 2020
• First Submitted That Met QC Criteria: August 13, 2020
• First Posted (ACTUAL): August 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 14, 2020
• Last Update Submitted That Met QC Criteria: August 13, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2019/37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No