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

• Sponsor: Afyonkarahisar Health Sciences University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04513873
• Collaborator: (none)
• Enrollment: 256
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.3
• Patients Per Site Per Month: 112.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pain and Anxiety of Children During Phlebotomy	Device: Equipment to divert the focus of children	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 256 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Effect Of Diverting The Children's Attention To A Different Point During Phlebotomy On Pain And Anxiety
• Actual Study Start Date: Jan 18, 2019
• Actual Primary Completion Date: Mar 28, 2019
• Actual Study Completion Date: Mar 28, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Assessment of Children's Anxiety Level Change [Twice ( Immediately after the procedure and 14 days after the procedure)]

   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.

Secondary Outcome Measures

1. Revised Face Pain Scale (FPS-R) [Twice ( During the procedure and 5-10 minutes after the procedure)]

   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."

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Manavgat State Hospital	Antalya	Manavgat	Turkey	07600

Sponsors and Collaborators

• Afyonkarahisar Health Sciences University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yeliz Ciğerci, Assistant Professor PhD, Afyonkarahisar Health Sciences University
• ClinicalTrials.gov Identifier: NCT04513873
• Other Study ID Numbers: 2019/37
• First Posted: Aug 14, 2020
• Last Update Posted: Aug 14, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of Aug 14, 2020