Two Different Therapeutic Interventions Applied During Blood Sampling in Children
The Effect of Two Different Therapeutic Interventions on Pain, Anxiety and Fear During Venipuncture in Children
This research is a three-group, randomized controlled experimental study designed to determine the effect of two different therapeutic interventions applied during blood sampling on pain, anxiety, and fear levels in children aged 5-7 years.
Children participating in the study will be randomly divided into three groups:
- Group (Experiment 1): Distraction method using betta fish observation
- Group (Experiment 2): Distraction method using hand puppets
- Group (Control): Routine clinical practice (without any therapeutic intervention) Before, during, and after blood sampling, children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be evaluated.
Study Overview
Status
Conditions
Detailed Description
This research is a three-group, randomized controlled experimental study designed to determine the effect of two different therapeutic interventions applied during blood sampling on pain, anxiety, and fear levels in children aged 5-7 years.
Children participating in the study will be randomly divided into three groups:
- Group (Experiment 1): Distraction method using betta fish observation
- Group (Experiment 2): Distraction method using hand puppets
- Group (Control): Routine clinical practice (without any therapeutic intervention) Before, during, and after blood sampling, children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be evaluated.
The obtained data will be compared using statistical analysis methods. The population of the study will consist of children aged 5-7 years who apply to the Pediatric Emergency Unit of Iğdır Dr. Nevruz Erez State Hospital and undergo venous blood sampling. The sample of the study will consist of children and their parents who meet the inclusion criteria and voluntarily agree to participate in the study. Children selected using an appropriate sampling method will be randomly assigned to three groups.
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Eda Gülbetekin, Assoc. Prof.
- Phone Number: 05398612688
- Email: edagulbetekin@gmail.com
Study Locations
-
-
Iğdır
-
Iğdır, Iğdır, Turkey (Türkiye), 76000
- Recruiting
- Igdır University
-
Contact:
- Eda Gülbetekin
- Phone Number: 05398612688
- Email: edagulbetekin@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being between 5 and 7 years old,
- Having a scheduled venous blood sampling procedure in the Pediatric Emergency Unit,
- Having a level of consciousness suitable for communication,
- The child and their parents agreeing to participate in the study,
- Being able to communicate in Turkish.
Exclusion Criteria:
Inability to participate in the application due to visual or hearing problems,
- Inability to administer the scales due to a developmental or neurological disease,
- Being under the influence of sedative or analgesic medication,
- Inability to complete the application during the research process,
- Lack of parental consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: experimental group
Distraction method using betta fish observation Participation in the study is entirely voluntary. After the purpose of the study is explained to the experimental group by the researcher and written and verbal permission is obtained from those who voluntarily agree to participate in the study, the pre-test data will be collected by the researcher. 355 This research is a carefully planned, three-group, randomized controlled study designed to determine the levels of pain, anxiety, and fear experienced by children aged 5-7 years during blood sampling using two different therapeutic interventions. The working children will be randomly assigned to three groups: Group 1 (Experiment 1): Distraction method using betta fish observation |
Before, during, and after blood sampling, the children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be assessed. The obtained data will be compared using statistical analysis methods. Group 1 (Experiment 1): Distraction method using betta fish observation |
|
Experimental: Experimental: experimental 2 group
Hand puppet distraction method This research is a carefully planned, three-group, randomized controlled study designed to determine the levels of pain, anxiety, and fear experienced by children aged 5-7 years during blood sampling with two different therapeutic interventions.
The working children will be randomly assigned to three groups: Group 2 (Experiment 2): Hand puppet distraction method
|
Before, during, and after blood sampling, the children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be assessed. The obtained data will be compared using statistical analysis methods. Group 2 (Experiment 2): Distraction method using hand puppets |
|
Experimental: Experimental: Experimental: Control Group
Standart of care This research is a carefully planned, three-group, randomized controlled trial to determine the levels of pain, anxiety, and fear experienced by children aged 5-7 years during blood sampling with two different therapeutic interventions. The working children will be randomly assigned to three groups: Group 3 (Control): Routine clinical practice (without any therapeutic intervention) |
Before, during, and after blood sampling, the children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be assessed. The obtained data will be compared using statistical analysis methods. Group 3 (Control): Routine clinical practice (without any therapeutic intervention) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
FLACC Pain Assessment Scale
Time Frame: through study completion, an average of 1 year
|
This scale is a pain scale assess pain in children aged 2 months to 7 years.It evaluates leg movements, facial expression, crying, and soothing ability and activity behaviors in relation to the pain experienced by the child.
These behaviors are scored using a scale of 0, 1, and 2 points.
A score of '0' indicates the absence of pain, '1-3' indicates mild pain, '4-6' indicates moderate pain, and '7-10' indicates the presence of severe pain.
|
through study completion, an average of 1 year
|
|
Children's Fear Scale
Time Frame: through study completion, an average of 1 year
|
The scale is designed for children aged 5 to 10 years. A talented graphic artist developed visual depictions showing changes in facial muscles associated with fear, using photographs of individuals with anxious facial expressions. The scale can be used by parents, children, or researchers to assess children's fear levels. The child is presented with a scale consisting of five facial expressions, each scored between "0" and "4". A score of "0" indicates a fearless, neutral expression, while "4" represents the highest level of fear. The scores progress as follows: "0" (neutral statement/no fear), "1" (very little fear), "2" (some fear), "3" (more fear) and "4" (highest possible fear). This scale can be used to measure fear both before and during the procedure. |
through study completion, an average of 1 year
|
|
Child Anxiety Scale
Time Frame: through study completion, an average of 1 year
|
The "Child Anxiety Scale-State (CAS-S)," which resembles a thermometer with horizontal lines, is scored from 0 to 10.
It is a scale developed for children aged 4-10 years.
When the scale is introduced to the child, it is stated that there is no anxiety, that anxiety increases as the scale moves upwards, and that the anxiety level is very high at the top.
Then, the child is asked to indicate the level of anxiety or tension they feel with a line.
The scale, developed by Ersig et al. (Ersig et al., 2013) in 2013, had its Turkish validity and reliability study conducted by Gerçeker et al. in 2018 (Gerçeker et al., 2018).
The "Child Anxiety Scale-State (CAS-S)," which resembles a thermometer with horizontal lines, is scored from 0 to 10.
It is a scale developed for children aged 4-10 years.
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Eda4
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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