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Completed

NCT Number: NCT05453305

Venopuncture in Pediatric Emergency Department Using Koala's Distraction Method

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.

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Key information

Conditions

Nursing Caries Anxiety Disorders Disease Attributes Emergencies Mental Disorders Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Venous Puncture

Age range

3 year–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control group: Traditional venipuncture, on the stretcher.

Procedure

The companion will be given the State/Trait Anxiety Questionnaire(STAI) for the initial assessment of the companion's anxiety and will be asked to recall their perceived emotions during the venipuncture. The observer will assess child pain and stress using FLACC and Groningen scale and will record it. Next, the companion will place the child on the stretcher in supine position with the limb to be punctured in decline. During the technique, the companion will be present, being able to participate by establishing links of consolation or distraction, as is usually done in the hospital. Simultaneously, a professional from the service will be in charge of holding the chosen extremity, as well as the opposite one. The responsible nurse will perform the venipuncture and/or collecting samples. The observer will assess child's pain and stress and caregiver's STAI during the intervention with the same scales.

Intervention group: DAK method venipuncture, simulating a hug

Procedure

The companion will be given the State/Trait Anxiety Questionnaire(STAI) for the initial evaluation of the companion's anxiety and will be asked to recall their perceived emotions during the venipuncture. The observer will assess child's pain and stress using the FLACC and Groningen scale and record it. Subsequently, the caregiver will sit in a chair placing the child on top in front of him, with one leg on each side and the arms resting on the shoulders of the companion. The patient's head will rest on the adult's shoulder, contralateral to the limb to be punctured. Simultaneously, the responsible adult patient will hold the simulating a hug. A professional will take care of immobilizing the chosen limb. The responsible nurse performed the venipuncture and collecting samples. The observer will assess the child's pain and stress during the intervention, and will deliver the STAI to the caregiver, to be completed with their perceived sensations during the technique.

Primary outcomes

  1. To measure changes in the child's pain during venipuncture using the Koala Attachment Distraction (DAK) method.

    Time frame: Two time points: Baseline (previous venipuncture) and during procedure (blood draw)

    The observer will assess child pain using Face, Legs, Activity and Consolability (FLACC) scale, each category is scored 0-2. Total score goes from 0, which indicates relaxed and comfortable to 10, severe pain.

  2. To measure changes in the child's stress during venipuncture using the Koala Attachment Distraction (DAK) method.

    Time frame: Two time points: Baseline (previous venipuncture) and during procedure (blood draw)

    Stress will be recorded with Groningen Distress Scale (GDS) which goes from 1 (calm not cry) to 5 (agitated, physical resistance y screaming).

Secondary outcomes

  1. To measure changes in the level of pain in the child's venipunctured using physical restraint and compare to the DAK method.

    Time frame: Two time points: Baseline (previous venipuncture) and during procedure (blood draw)

    The observer will assess child pain using Face, Legs, Activity and Consolability (FLACC) scale, each category is scored 0-2. Total score goes from 0, which indicates relaxed and comfortable to10, severe pain.

  2. To measure changes in the level of stress in the child's venipunctured using physical restraint and compare to the DAK method.

    Time frame: Two time points: Baseline (previous venipuncture) and during procedure (blood draw)

    Stress will be recorded with Groningen Distress Scale (GDS) which goes from 1 (calm not cry) to 5 (agitated, physical resistance y screaming).

  3. To measure the changes in the level of perceived anxiety of companions when performing venipuncture with the DAK method and physical restraint.

    Time frame: Two time points: Baseline (previous venipuncture) and immediately after procedure (blood draw), where companion must recall their perceived emotions during venipuncture.

    The companion will be given the State part of the State/Trait Anxiety Questionnaire(STAI) Result goes from 0 to 30, being higher scores higher anxiety levels.

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Sanitaria Aragón

Other

Registry information

Official study title

Venopuncture in Pediatric Emergency Department Using Koala's Distraction Method. Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 12, 2022
Registry last updated
Jul 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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