Venopuncture in Pediatric Emergency Department Using Koala's Distraction Method

Sponsor

Instituto de Investigación Sanitaria Aragón (Other)

Overall Status

Completed

CT.gov ID

NCT05453305

Collaborator

(none)

220

Enrollment

Location

Arms

12.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nursing Caries Emergencies Venous Puncture	Procedure: Control group: Traditional venipuncture, on the stretcher. Procedure: Intervention group: DAK method venipuncture, simulating a hug	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jun 1, 2021

Actual Primary Completion Date :

Jun 30, 2022

Actual Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control group: Traditional venipuncture, on the stretcher. the companion will place the child on the stretcher in the supine position with the limb to be punctured in decline. At all times, 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 while another colleague will help with tasks of holding and/or collecting samples.	Procedure: Control group: Traditional venipuncture, on the stretcher. 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.
Experimental: Experimental group: DAK method venipuncture, simulating a hug. 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 while another colleague helped with the tasks of holding and/or collecting samples.	Procedure: Intervention group: DAK method venipuncture, simulating a hug 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.

Arm

Intervention/Treatment

Active Comparator: Control group: Traditional venipuncture, on the stretcher.

the companion will place the child on the stretcher in the supine position with the limb to be punctured in decline. At all times, 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 while another colleague will help with tasks of holding and/or collecting samples.

Procedure: Control group: Traditional venipuncture, on the stretcher.

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.

Experimental: Experimental group: DAK method venipuncture, simulating a hug.

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 while another colleague helped with the tasks of holding and/or collecting samples.

Procedure: Intervention group: DAK method venipuncture, simulating a hug

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.

Outcome Measures

Primary Outcome Measures

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

To measure changes in the level of pain in the child's venipunctured using physical restraint and compare to the DAK method. [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.
To measure changes in the level of stress in the child's venipunctured using physical restraint and compare to the DAK method. [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).
To measure the changes in the level of perceived anxiety of companions when performing venipuncture with the DAK method and physical restraint. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 4 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Miguel Servet	Zaragoza		Spain	50009

Sponsors and Collaborators

Instituto de Investigación Sanitaria Aragón

Investigators

Principal Investigator: Tania Fernández, Nursing, Hospital Universitario Miguel Servet (Zaragoza, Spain)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Instituto de Investigación Sanitaria Aragón

ClinicalTrials.gov Identifier:

NCT05453305

Other Study ID Numbers:

PI21/218

First Posted:

Jul 12, 2022

Last Update Posted:

Jul 12, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Instituto de Investigación Sanitaria Aragón

Additional relevant MeSH terms:

Emergencies

Study Results

No Results Posted as of Jul 12, 2022