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

Pain and Anxiety of Children During Phlebotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04513873
• Other study ID #: 2019/37
• Status: Completed
• Phase: N/A
• Start date: January 18, 2019
• Est. completion date: March 28, 2019

Study information

• Verified date: August 2020
• Source: Afyonkarahisar University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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?"

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: March 28, 2019
• Est. primary completion date: March 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Pain and Anxiety of Children During Phlebotomy

Intervention

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.

Locations

Country	Name	City	State
Turkey	Manavgat State Hospital	Antalya	Manavgat

Sponsors (1)

Lead Sponsor	Collaborator
Afyonkarahisar University of Health Sciences

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)