Pain, Acute Clinical Trial
Official title:
The Effect of "Quantum-Touch" on Venipuncture Pain, Fear, and Anxiety in Children Aged 7-12 Years Old; Randomized Controlled Study
NCT number | NCT05828264 |
Other study ID # | KU |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 1, 2022 |
Est. completion date | April 1, 2023 |
Verified date | April 2023 |
Source | Trakya University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This research is a randomized controlled experimental study designed to determine the effect of the Quantum-Touch method applied during the vascular access procedure in children aged 7-12 years, on the level of pain, fear and anxiety in children.
Status | Completed |
Enrollment | 113 |
Est. completion date | April 1, 2023 |
Est. primary completion date | April 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years to 12 Years |
Eligibility | Inclusion Criteria: - The child and family agree to participate in the research, - The child's being literate, - The child is between the ages of 7-12 - The child does not have a chronic and mental health problem. - No history of sedative, analgesic or narcotic substance use within 24 hours before admission - Not having a febrile illness at the time of application - Previous vascular access Exclusion Criteria: - The child and family do not agree to participate in the research, - The child's illiteracy, - Having a visual and auditory problem, - The child is less than 7 years old or older than 12 years old - The child has a chronic and mental health problem - Failure to open vascular access in a single attempt - Having a phobia of pain |
Country | Name | City | State |
---|---|---|---|
Turkey | Remziye Semerci | Edirne | Center |
Lead Sponsor | Collaborator |
---|---|
Trakya University | Koç University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Faces Pain Scale-Revize (FPS-R | This scale consists of 6 facial expressions graded from 0 to 10 according to the presence and severity of pain, and its use is common in children aged 4-16. FPS-R is a valid and reliable individual expression sensitive scale in painful situations in children. | One minute after the venipuncture procedure | |
Primary | Child Fear Scale | In this scale, the child is shown a picture containing five facial expressions evaluated between 0 and 4. 0 indicates no fear or anxiety; 4 indicates the highest fear and anxiety. These; "0" neutral expression (no anxiety) "1" little fear (very little anxiety) "2" some fear (some anxiety) "3" more fear (more anxiety) "4" highest possible fear (severe anxiety) . | One minute after the venipuncture procedure | |
Primary | Child Anxiety Scale-State | ÇAS-D is similar to a thermometer with a light bulb at the bottom and horizontal lines at intervals that go up. The scale is aimed at children aged 4-10 years. To measure state anxiety (CAS-D), the child is asked to mark what he feels "right now". | One minute after the venipuncture procedure |
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