Nursing CariesNCT05453305
Venopuncture in Pediatric Emergency Department Using Koala's Distraction Method
A study testing Intervention group: DAK method venipuncture, simulating a hug in people with Nursing Caries and Emergencies, run by Instituto de Investigación Sanitaria Aragón at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 4 years
- Conditions the study is for
- Nursing Caries, Emergencies, Venous Puncture
- What is being tested?
- Intervention group: DAK method venipuncture, simulating a hug
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3 and 4 years who require venipuncture in the Emergency Department.
- To signature of the informed consent by the patient's companion.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Venopuncture in Pediatric Emergency Department Using Koala's Distraction Method. Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Nursing Caries, Emergencies, Venous Puncture
- Being tested
- Control group: Traditional venipuncture, on the stretcher., Intervention group: DAK method venipuncture, simulating a hug
- Keywords
- Venipuncture, pain, anxiety, stress
- Medical subject headings
- Emergencies, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control group: Traditional venipuncture, on the stretcher.Procedure or surgery
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 hugProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group: Traditional venipuncture, on the stretcher. | Active comparator | 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. Receives: Procedure: Control group: Traditional venipuncture, on the stretcher. |
| Experimental group: DAK method venipuncture, simulating a hug. | Experimental | 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. Receives: Procedure: Intervention group: DAK method venipuncture, simulating a hug |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two time points: Baseline (previous venipuncture) and during procedure (blood draw)
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).
Measured: Two time points: Baseline (previous venipuncture) and during procedure (blood draw)
Secondary outcomes (3)
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.
Measured: Two time points: Baseline (previous venipuncture) and during procedure (blood draw)
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).
Measured: Two time points: Baseline (previous venipuncture) and during procedure (blood draw)
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.
Measured: Two time points: Baseline (previous venipuncture) and immediately after procedure (blood draw), where companion must recall their perceived emotions during venipuncture.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start1 Jun 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Nursing CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria Aragón
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tania Fernández, Nursing, Principal investigator, Hospital Universitario Miguel Servet (Zaragoza, Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453305
- Sponsor's protocol ID
- PI21/218
- Status last verified
- May 2022
- First submitted
- 14 Jun 2022
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ali S, McGrath T, Drendel AL. An Evidence-Based Approach to Minimizing Acute Procedural Pain in the Emergency Department and Beyond. Pediatr Emerg Care. 2016 Jan;32(1):36-42; quiz 43-4. doi: 10.1097/PEC.0000000000000669.
PubMed 26720064Hartling L, Newton AS, Liang Y, Jou H, Hewson K, Klassen TP, Curtis S. Music to reduce pain and distress in the pediatric emergency department: a randomized clinical trial. JAMA Pediatr. 2013 Sep;167(9):826-35. doi: 10.1001/jamapediatrics.2013.200.
PubMed 23857075Shave 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.
PubMed 30316301Thompson S, Ayers S, Pervilhac C, Mahoney L, Seddon P. The association of children's distress during venepuncture with parent and staff behaviours. J Child Health Care. 2016 Sep;20(3):267-76. doi: 10.1177/1367493515598643. Epub 2015 Aug 27.
PubMed 26316521Yoo H, Kim S, Hur HK, Kim HS. The effects of an animation distraction intervention on pain response of preschool children during venipuncture. Appl Nurs Res. 2011 May;24(2):94-100. doi: 10.1016/j.apnr.2009.03.005. Epub 2009 Jul 15.
PubMed 20974061Bailey B, Trottier ED. Managing Pediatric Pain in the Emergency Department. Paediatr Drugs. 2016 Aug;18(4):287-301. doi: 10.1007/s40272-016-0181-5.
PubMed 27260499Bahorski JS, Hauber RP, Hanks C, Johnson M, Mundy K, Ranner D, Stoutamire B, Gordon G. Mitigating procedural pain during venipuncture in a pediatric population: A randomized factorial study. Int J Nurs Stud. 2015 Oct;52(10):1553-64. doi: 10.1016/j.ijnurstu.2015.05.014. Epub 2015 Jun 10.
PubMed 26118441Garcia-Aracil N, Ramos-Pichardo JD, Castejon-de la Encina ME, Jose-Alcaide L, Julia-Sanchis R, Sanjuan-Quiles A. Effectiveness of non-pharmacological measures for reducing pain and fear in children during venipuncture in the emergency department: a vibrating cold devices versus distraction. Emergencias. 2018 Jun;30(3):182-185. English, Spanish.
PubMed 29687673Vagnoli L, Caprilli S, Vernucci C, Zagni S, Mugnai F, Messeri A. Can presence of a dog reduce pain and distress in children during venipuncture? Pain Manag Nurs. 2015 Apr;16(2):89-95. doi: 10.1016/j.pmn.2014.04.004. Epub 2014 Nov 4.
PubMed 25439114Canbulat N, Ayhan F, Inal S. Effectiveness of external cold and vibration for procedural pain relief during peripheral intravenous cannulation in pediatric patients. Pain Manag Nurs. 2015 Feb;16(1):33-9. doi: 10.1016/j.pmn.2014.03.003. Epub 2014 Jun 7.
PubMed 24912740Brenner SM, Rupp V, Boucher J, Weaver K, Dusza SW, Bokovoy J. A randomized, controlled trial to evaluate topical anesthetic for 15 minutes before venipuncture in pediatrics. Am J Emerg Med. 2013 Jan;31(1):20-5. doi: 10.1016/j.ajem.2012.05.003. Epub 2012 Jul 16.
PubMed 22809774Oliveira NC, Santos JL, Linhares MB. Audiovisual distraction for pain relief in paediatric inpatients: A crossover study. Eur J Pain. 2017 Jan;21(1):178-187. doi: 10.1002/ejp.915. Epub 2016 Jul 26.
PubMed 27461092Pillai Riddell RR, Racine NM, Turcotte K, Uman LS, Horton RE, Din Osmun L, Ahola Kohut S, Hillgrove Stuart J, Stevens B, Gerwitz-Stern A. Non-pharmacological management of infant and young child procedural pain. Cochrane Database Syst Rev. 2011 Oct 5;(10):CD006275. doi: 10.1002/14651858.CD006275.pub2.
PubMed 21975752
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venopuncture in Pediatric Emergency Department Using Koala's Distraction Method. Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05453305
- Acronym / sponsor ID
- PI21/218
- Conditions
- Nursing Caries, Emergencies, Venous Puncture
- Keywords
- Venipuncture, pain, anxiety, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria AragónUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group: Traditional venipuncture, on the stretcher. | Active comparator | Procedure: 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. |
| Experimental group: DAK method venipuncture, simulating a hug. | Experimental | Procedure: Intervention group: DAK method venipuncture, simulating a hugthe 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. |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 3 and 4 years who require venipuncture in the Emergency Department.
- To signature of the informed consent by the patient's companion.
Key exclusion criteria (8 listed)
- 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".
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Control group: Traditional venipuncture, on the stretcher. |
| Intervention group: DAK method venipuncture, simulating a hugThe 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. | Procedure or surgery | Experimental group: DAK method venipuncture, simulating a hug. |
Primary outcome
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.
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).
3 secondary outcomes
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)
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)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Results publication: PubMed 26720064Ali S, McGrath T, Drendel AL. An Evidence-Based Approach to Minimizing Acute Procedural Pain in the Emergency Department and Beyond. Pediatr Emerg Care. 2016 Jan;32(1):36-42; quiz 43-4. doi: 10.1097/PEC.0000000000000669.
- Results publication: PubMed 23857075Hartling L, Newton AS, Liang Y, Jou H, Hewson K, Klassen TP, Curtis S. Music to reduce pain and distress in the pediatric emergency department: a randomized clinical trial. JAMA Pediatr. 2013 Sep;167(9):826-35. doi: 10.1001/jamapediatrics.2013.200.
- Results publication: PubMed 30316301Shave 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 publication: PubMed 26316521Thompson S, Ayers S, Pervilhac C, Mahoney L, Seddon P. The association of children's distress during venepuncture with parent and staff behaviours. J Child Health Care. 2016 Sep;20(3):267-76. doi: 10.1177/1367493515598643. Epub 2015 Aug 27.
- Results publication: PubMed 20974061Yoo H, Kim S, Hur HK, Kim HS. The effects of an animation distraction intervention on pain response of preschool children during venipuncture. Appl Nurs Res. 2011 May;24(2):94-100. doi: 10.1016/j.apnr.2009.03.005. Epub 2009 Jul 15.
- Results publication: PubMed 27260499Bailey B, Trottier ED. Managing Pediatric Pain in the Emergency Department. Paediatr Drugs. 2016 Aug;18(4):287-301. doi: 10.1007/s40272-016-0181-5.
- Results publication: PubMed 26118441Bahorski JS, Hauber RP, Hanks C, Johnson M, Mundy K, Ranner D, Stoutamire B, Gordon G. Mitigating procedural pain during venipuncture in a pediatric population: A randomized factorial study. Int J Nurs Stud. 2015 Oct;52(10):1553-64. doi: 10.1016/j.ijnurstu.2015.05.014. Epub 2015 Jun 10.
- Results publication: PubMed 29687673Garcia-Aracil N, Ramos-Pichardo JD, Castejon-de la Encina ME, Jose-Alcaide L, Julia-Sanchis R, Sanjuan-Quiles A. Effectiveness of non-pharmacological measures for reducing pain and fear in children during venipuncture in the emergency department: a vibrating cold devices versus distraction. Emergencias. 2018 Jun;30(3):182-185. English, Spanish.
- Results publication: PubMed 25439114Vagnoli L, Caprilli S, Vernucci C, Zagni S, Mugnai F, Messeri A. Can presence of a dog reduce pain and distress in children during venipuncture? Pain Manag Nurs. 2015 Apr;16(2):89-95. doi: 10.1016/j.pmn.2014.04.004. Epub 2014 Nov 4.
- Results publication: PubMed 24912740Canbulat N, Ayhan F, Inal S. Effectiveness of external cold and vibration for procedural pain relief during peripheral intravenous cannulation in pediatric patients. Pain Manag Nurs. 2015 Feb;16(1):33-9. doi: 10.1016/j.pmn.2014.03.003. Epub 2014 Jun 7.
- Results publication: PubMed 22809774Brenner SM, Rupp V, Boucher J, Weaver K, Dusza SW, Bokovoy J. A randomized, controlled trial to evaluate topical anesthetic for 15 minutes before venipuncture in pediatrics. Am J Emerg Med. 2013 Jan;31(1):20-5. doi: 10.1016/j.ajem.2012.05.003. Epub 2012 Jul 16.
- Results publication: PubMed 27461092Oliveira NC, Santos JL, Linhares MB. Audiovisual distraction for pain relief in paediatric inpatients: A crossover study. Eur J Pain. 2017 Jan;21(1):178-187. doi: 10.1002/ejp.915. Epub 2016 Jul 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tania Fernández, Nursing principal investigator
Hospital Universitario Miguel Servet (Zaragoza, Spain)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group: DAK method venipuncture, simulating a hug in people with Nursing Caries and Emergencies, run by Instituto de Investigación Sanitaria Aragón at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05453305, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022; AzTrials last refreshed its copy on 4 Nov 2026.