Clinical trial NCT06772259: Comparison of the Effect of Two Different Interventions
Official title: Comparison of the Effect of Two Different Interventions on Pain and Fear in Peripheric Intravenous Catheterization in Children: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: To Compare the Effect of Two Different Nonpharmacological Methods on Pain and Fear During Peripheral Intravenous Catheterization
Keywords: pain
fear
children
distraction
palm stimulator
cartoon
peripheral intravenous
catheterization
cannulation
Lead sponsor: Sakarya University
Sponsor class: OTHER
Collaborators: name: Sakarya University Education and Research Hospital
First posted: 2025-01-13
Enrollment: 90
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to compare the effect of two different non-pharmacologic interventions with the control group in reducing pain due to peripheral intravenous catheterization application in children aged 5-12 years.

Hypotheses:

H1: Pain level differs in the group that received PIK with Palm Stimulator compared to the control group.

H2: The level of fear in the group with PIK application with Palm Stimulator differs from the control group.

H3: Satisfaction level is different in the group with PIK application with Palm Stimulator compared to the control group.

H4: The pain level differs in the group that received PIK application by watching cartoons compared to the control group.

H5: The level of fear is different in the group that received PIK application by watching cartoons compared to the control group.

H6: Satisfaction level is different in the group that received PIK application by watching cartoons compared to the control group.

H7: Pain level is different in the Palm Stimulator PIK group compared to the cartoon group.

H8: The level of fear is different in the Palm Stimulator PIK group compared to the cartoon group.

H9: The satisfaction level in the group with PIK application with Palm Stimulator is different from the cartoon group.

H10: PIK application time is different in the palm stimulator group compared to the control group.

H11: PIK application time is different in the cartoon group compared to the co

Detailed description: 1. To measure the pain and fear levels of children by placing a palm stimulator on their palms during PIK application
2. Measuring pain and fear levels by watching cartoons to children during PIK application

Eligibility criteria: Inclusion Criteria:

1. Voluntary participation in the study,
2. Pediatric patients for whom written and verbal consent has been obtained from the parent,
3. Pediatric patients for whom verbal consent was obtained,

(3) Not under the influence of sedative/anticonvulsant/analgesic drugs, (4) Pediatric patients aged 5-12 years, (5) Pediatric patients who can communicate, understand, and carry out commands and are not dependent on technological devices.

Exclusion Criteria:

1. Not volunteering to participate in the study,
2. More than one PIK attempt,
3. Children with a chronic, acute, or life-threatening illness.

Primary outcomes:
measure: Pain Measurement
timeFrame: 3 months
measure: Fear
timeFrame: 3 months
Secondary outcomes:
measure: Saticfaction
timeFrame: 3 months
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya University
state: Serdivan
Study officials:
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