Back to resultsThe Effect Of Diverting The Children's Attention To A Different Point During Phlebotomy
Primary Purpose
Pain and Anxiety of Children During Phlebotomy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Equipment to divert the focus of children
Sponsored by
About this trial
This is an interventional supportive care trial for Pain and Anxiety of Children During Phlebotomy
Eligibility Criteria
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
Sites / Locations
- Manavgat State Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Equipment Intervention Group
No Intervention Group
Arm Description
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.
Standard blood collection procedures were applied to the control group.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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."
Full Information
NCT ID
NCT04513873
First Posted
August 8, 2020
Last Updated
August 13, 2020
Sponsor
Afyonkarahisar Health Sciences University
1. Study Identification
Unique Protocol Identification Number
NCT04513873
Brief Title
The Effect Of Diverting The Children's Attention To A Different Point During Phlebotomy
Official Title
The Effect Of Diverting The Children's Attention To A Different Point During Phlebotomy On Pain And Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 18, 2019 (Actual)
Primary Completion Date
March 28, 2019 (Actual)
Study Completion Date
March 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Afyonkarahisar Health Sciences University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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?"
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain and Anxiety of Children During Phlebotomy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
256 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Equipment Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
No Intervention Group
Arm Type
No Intervention
Arm Description
Standard blood collection procedures were applied to the control group.
Intervention Type
Device
Intervention Name(s)
Equipment to divert the focus of children
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of Children's Anxiety Level Change
Description
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.
Time Frame
Twice ( Immediately after the procedure and 14 days after the procedure)
Secondary Outcome Measure Information:
Title
Revised Face Pain Scale (FPS-R)
Description
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."
Time Frame
Twice ( During the procedure and 5-10 minutes after the procedure)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Manavgat State Hospital
City
Antalya
State/Province
Manavgat
ZIP/Postal Code
07600
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect Of Diverting The Children's Attention To A Different Point During Phlebotomy
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