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Venopuncture in Pediatric Emergency Department Using Koala's Distraction Method

Primary Purpose

Nursing Caries, Emergencies, Venous Puncture

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Control group: Traditional venipuncture, on the stretcher.
Intervention group: DAK method venipuncture, simulating a hug
Sponsored by
Instituto de Investigación Sanitaria Aragón
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nursing Caries focused on measuring Venipuncture, pain, anxiety, stress

Eligibility Criteria

3 Years - 4 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Universitario Miguel Servet

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group: Traditional venipuncture, on the stretcher.

Experimental group: DAK method venipuncture, simulating a hug.

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
June 14, 2022
Last Updated
July 11, 2022
Sponsor
Instituto de Investigación Sanitaria Aragón
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1. Study Identification

Unique Protocol Identification Number
NCT05453305
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Sanitaria Aragón

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nursing Caries, Emergencies, Venous Puncture
Keywords
Venipuncture, pain, anxiety, stress

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group: Traditional venipuncture, on the stretcher.
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Experimental group: DAK method venipuncture, simulating a hug.
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Control group: Traditional venipuncture, on the stretcher.
Intervention Description
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 Type
Procedure
Intervention Name(s)
Intervention group: DAK method venipuncture, simulating a hug
Intervention Description
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 Outcome Measure Information:
Title
To measure changes in the child's pain during venipuncture using the Koala Attachment Distraction (DAK) method.
Description
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.
Time Frame
Two time points: Baseline (previous venipuncture) and during procedure (blood draw)
Title
To measure changes in the child's stress during venipuncture using the Koala Attachment Distraction (DAK) method.
Description
Stress will be recorded with Groningen Distress Scale (GDS) which goes from 1 (calm not cry) to 5 (agitated, physical resistance y screaming).
Time Frame
Two time points: Baseline (previous venipuncture) and during procedure (blood draw)
Secondary Outcome Measure Information:
Title
To measure changes in the level of pain in the child's venipunctured using physical restraint and compare to the DAK method.
Description
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.
Time Frame
Two time points: Baseline (previous venipuncture) and during procedure (blood draw)
Title
To measure changes in the level of stress in the child's venipunctured using physical restraint and compare to the DAK method.
Description
Stress will be recorded with Groningen Distress Scale (GDS) which goes from 1 (calm not cry) to 5 (agitated, physical resistance y screaming).
Time Frame
Two time points: Baseline (previous venipuncture) and during procedure (blood draw)
Title
To measure the changes in the level of perceived anxiety of companions when performing venipuncture with the DAK method and physical restraint.
Description
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.
Time Frame
Two time points: Baseline (previous venipuncture) and immediately after procedure (blood draw), where companion must recall their perceived emotions during venipuncture.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tania Fernández, Nursing
Organizational Affiliation
Hospital Universitario Miguel Servet (Zaragoza, Spain)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26720064
Citation
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Results Reference
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Citation
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Results Reference
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Citation
Shave K, Ali S, Scott SD, Hartling L. Procedural pain in children: a qualitative study of caregiver experiences and information needs. BMC Pediatr. 2018 Oct 13;18(1):324. doi: 10.1186/s12887-018-1300-y.
Results Reference
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Citation
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Results Reference
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Venopuncture in Pediatric Emergency Department Using Koala's Distraction Method

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