Clinical trial NCT05453305: Venopuncture in Pediatric Emergency Department Using Koala's Distraction Method
Official title: Venopuncture in Pediatric Emergency Department Using Koala's Distraction Method. Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Caries
Emergencies
Venous Puncture
Keywords: Venipuncture
pain
anxiety
stress
Lead sponsor: Instituto de Investigación Sanitaria Aragón
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 220
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A randomized clinical trial will be performed. Patients aged 3 and 4 years who attend the pediatric emergency service of the Miguel Servet Hospital in Zaragoza and require venipuncture will be selected. In the control group, traditional venipuncture will be performed, placing the child in supine position on the stretcher with the limb to be punctured in decline. In the intervention group, the DAK method will be used, where the adult will hold the child simulating a hug. A professional will take care of immobilizing the chosen limb, and the nurse will perform the venipuncture. The researchers believe that 3 and 4-year-old children subjected to venipuncture using the Koala Attachment Distraction method present a lower level of stress and pain, as well as their companions a lower level of anxiety, compared to those subjected to physical restraint.

Condition of disease: Patients aged 3 and 4 years, who attend the pediatric emergency service of the Miguel Servet Hospital in Zaragoza and require venipuncture.

Intervention: Traditional venipuncture, in supine position on the stretcher with the limb to be punctured in decline. + DAK method, simulating a hug.

Detailed description: A randomized clinical trial will be performed. 220 participants between 3 and 4 years old will be selected and randomized to participate. Control group and experimental group will enrolled 110 participants each one. Control group will be venipunctured in the traditional way. Intervention group will be venipunctured using the DAK method. Before and during the venipuncture, three tests will be performed. To assess level's pain, before and during the technique, the Face, Legs, Activity and Consolability (FLACC) scale will be used, obtaining an assessment of maximum, severe, moderate, mild or no pain.

To evaluate the child's stress, before and during the technique, the Groningen Anxiety Scale will be used, which assesses 3 items: the child's condition, muscle tension and crying, classifying them in 5 degrees from least to greatest stress. To assess the perceived anxiety of the companion, the State-Trait Anxiety Inventory (STAI) questionnaire will be used, classifying it in percentiles according to age and sex. In both groups, a trained observer will evaluate the child's pain and stress before and during the technique, and the companion will fill out the STAI questionnaire. Study participants will be required to read an information sheet and sign an informed consent.

Eligibility criteria: Inclusion Criteria:

* Children aged 3 and 4 years who require venipuncture in the Emergency Department.
* To signature of the informed consent by the patient's companion.

Exclusion Criteria:

* Children with psychomotor retardation, due to difficulties in assessing stress and pain in this group of patients.
* Cancer patients with subcutaneous reservoir.
* Patients with diabetes mellitus or other pathologies that imply alterations in the sensitivity of the skin.
* Children classified as priority level I or II in triage.
* Children with special needs and/or classified as "minimum waiting".
* Children with an inability to understand and express the language (linguistic barrier).
* Previous administration of analgesic, sedative or relaxing drugs.
* Prior venipuncture less than 24 hours.

Primary outcomes:
measure: To measure changes in the child's pain during venipuncture using the Koala Attachment Distraction (DAK) method.
timeFrame: Two time points: Baseline (previous venipuncture) and during procedure (blood draw)
measure: To measure changes in the child's stress during venipuncture using the Koala Attachment Distraction (DAK) method.
timeFrame: Two time points: Baseline (previous venipuncture) and during procedure (blood draw)
Secondary outcomes:
measure: To measure changes in the level of pain in the child's venipunctured using physical restraint and compare to the DAK method.
timeFrame: Two time points: Baseline (previous venipuncture) and during procedure (blood draw)
measure: To measure changes in the level of stress in the child's venipunctured using physical restraint and compare to the DAK method.
timeFrame: Two time points: Baseline (previous venipuncture) and during procedure (blood draw)
measure: To measure the changes in the level of perceived anxiety of companions when performing venipuncture with the DAK method and physical restraint.
timeFrame: Two time points: Baseline (previous venipuncture) and immediately after procedure (blood draw), where companion must recall their perceived emotions during venipuncture.
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Hospital Universitario Miguel Servet (Zaragoza, Spain)
name: Tania Fernández, Nursing
role: PRINCIPAL_INVESTIGATOR
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