Two Different Therapeutic Interventions Applied During Blood Sampling in Children
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age5-7
SponsorIgdir University
About this trial
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:
1. Group (Experiment 1): Distraction method using betta fish observation 2. Group (Experiment 2): Distraction method using hand puppets 3. 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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,
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
experimental group
Combination productBefore, 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
experiment group
Combination productBefore, 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
Control Group
Combination productBefore, 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)
Treatment groups
105 Participants
are divided into 3 treatment groupsGroup A: Experimental: experimental groupExperimental treatment 1 intervention
Group B: Experimental: experimental 2 groupExperimental treatment 1 intervention
Group C: Experimental: Experimental: Control GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
FLACC Pain Assessment Scale
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.
Time frame
through study completion, an average of 1 year2
Children's Fear Scale
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.
Time frame
through study completion, an average of 1 year3
Child Anxiety Scale
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.
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov