PainNCT05758584
Effect of Vibrating Tourniquet and Distraction Cards on Pain and Anxiety in Children
A study testing Intervention and Distraction card in people with Pain and Anxiety, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to observe the effect of the use of vibrating tourniquet and distraction card on the pain, fear and anxiety levels felt during the blood collection process in children. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- What is being tested?
- Intervention and Distraction card
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 1 May 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child is between the ages of 6-10,
- The child has no pain just before the procedure,
- The child has not taken any analgesic-effective medication in the last 6 hours,
- The child does not have a hearing problem,
- The child and the parent can speak and understand Turkish
- The child has a sufficient level of mental development to understand speech -Parent and child are willing to participate in the research.
Who cannot join
- Children who cannot be successfully drawn in the first application
- Children with oncological disease, epilepsy, migraine, or vestibular disorder.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Turkey
Ankara, 06010
About this study
Official title: Effect of Vibrating Tourniquet and Distraction Cards on Pain and Anxiety Levels During Phlebotomy in Children
The aim of the study was to observe the effect of the use of vibrating tourniquet and distraction card on the pain, fear and anxiety levels felt during the blood collection process in children. The study was conducted between July 2021 and March 2022 as a randomized controlled study with totally 120 children in three groups. The 'Child and Parent Identification Form' was used for socio-demographic data about the child and the parent before phlebotomy. The 'Visual Analog Scale (VAS)', 'Child Fear Scale (CFS)' and 'Child Anxiety Scale-State Scale (ÇAS-D)' were used before, during and after the phlebotomy. Vibrating Tourniquet Group (intervention group 1) consists of a total of 40 children. Distraction Cards Group (intervention group 2) consists of a total of 40 children. Control group consists of a total of 40 children.
- Being tested
- Intervention, Distraction card
- Keywords
- pain, anxiety, children, nurse, phlebotomy
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
Also called Vibrating tourniquet
Vibrating tourniquet
Distraction cardOther
Distraction card
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Vibrating tourniquet group Receives: Other: Intervention |
| Group 2 | Experimental | Distraction cards group Receives: Other: Distraction card |
| Group 3 | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
change on pain intensity as measured by Visual Analog Scale
It is a 10 cm or 100 mm long horizontal or vertical line with anchor statements "no pain or pain at its least" at the left-most end and "unbearable pain or worst pain imaginable" at the right-most end. The VAS score is determined by measuring (in cm) the distance of the mark from the left end of the line.
Measured: "5-10 minutes before procedure", "during procedure" and "5 minutes after" blood collection process
Secondary outcomes (2)
Score change on state anxiety level as measured by Child Anxiety Scale State Scale (ÇAS-D)
The scale is in the form of a thermometer with horizontal lines. For 10 horizontal lines, the line at the bottom of the thermometer, '0', represents the lowest anxiety level, and the line at the top of the thermometer, i.e., '10', represents the highest level of anxiety.
Measured: "5-10 minutes before procedure" and "5 minutes after procedure" blood collection process
Score change on fear level as measured by Children's Fear Scale
These faces are showing different levels of anxiety. This face [point to the left-most face] shows no anxiety at all, this faces shows a little bit more [point to second face from left], a bit more [sweep finger along scale], right up to extreme anxiety [point to the last face on the right]. Have a look at these faces and choose the one that shows how much anxiety you felt during [the needle].
Measured: "5-10 minutes before procedure" and "5 minutes after procedure" blood collection process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start1 Jul 2021
- Primary completion1 Mar 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled study
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hümeyra Erdem, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758584
- Sponsor's protocol ID
- pain_fear_anxiety...///
- Status last verified
- Feb 2023
- First submitted
- 9 Nov 2022
- Last updated
- 7 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bergomi P, Scudeller L, Pintaldi S, Dal Molin A. Efficacy of Non-pharmacological Methods of Pain Management in Children Undergoing Venipuncture in a Pediatric Outpatient Clinic: A Randomized Controlled Trial of Audiovisual Distraction and External Cold and Vibration. J Pediatr Nurs. 2018 Sep-Oct;42:e66-e72. doi: 10.1016/j.pedn.2018.04.011. Epub 2018 May 1.
PubMed 29728296Bukola IM, Paula D. The Effectiveness of Distraction as Procedural Pain Management Technique in Pediatric Oncology Patients: A Meta-analysis and Systematic Review. J Pain Symptom Manage. 2017 Oct;54(4):589-600.e1. doi: 10.1016/j.jpainsymman.2017.07.006. Epub 2017 Jul 14.
PubMed 28712986Gerceker GO, Binay S, Bilsin E, Kahraman A, Yilmaz HB. Effects of Virtual Reality and External Cold and Vibration on Pain in 7- to 12-Year-Old Children During Phlebotomy: A Randomized Controlled Trial. J Perianesth Nurs. 2018 Dec;33(6):981-989. doi: 10.1016/j.jopan.2017.12.010. Epub 2018 Mar 17.
PubMed 29559294Diaz-Rodriguez M, Alcantara-Rubio L, Aguilar-Garcia D, Perez-Munoz C, Carretero-Bravo J, Puertas-Cristobal E. The Effect of Play on Pain and Anxiety in Children in the Field of Nursing: A Systematic Review. J Pediatr Nurs. 2021 Nov-Dec;61:15-22. doi: 10.1016/j.pedn.2021.02.022. Epub 2021 Mar 10.
PubMed 33711642
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vibrating Tourniquet and Distraction Cards on Pain and Anxiety Levels During Phlebotomy in Children
- ClinicalTrials.gov ID
- NCT05758584
- Acronym / sponsor ID
- pain_fear_anxiety...///
- Keywords
- pain, anxiety, children, nurse, phlebotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 7 Mar 2023 (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.
The aim of the study was to observe the effect of the use of vibrating tourniquet and distraction card on the pain, fear and anxiety levels felt during the blood collection process in children. The study was conducted between July 2021 and March 2022 as a randomized controlled study with totally 120 children in three groups. The 'Child and Parent Identification Form' was used for socio-demographic data about the child and the parent before phlebotomy. The 'Visual Analog Scale (VAS)', 'Child Fear Scale (CFS)' and 'Child Anxiety Scale-State Scale (ÇAS-D)' were used before, during and after the phlebotomy. Vibrating Tourniquet Group (intervention group 1) consists of a total of 40 children. Distraction Cards Group (intervention group 2) consists of a total of 40 children. Control group consists of a total of 40 children.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: InterventionVibrating tourniquet group |
| Group 2 | Experimental | Other: Distraction cardDistraction cards group |
| Group 3 | No intervention | –Control group |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- The child is between the ages of 6-10,
- The child has no pain just before the procedure,
- The child has not taken any analgesic-effective medication in the last 6 hours,
- The child does not have a hearing problem,
- The child and the parent can speak and understand Turkish
Key exclusion criteria (2 listed)
- Children who cannot be successfully drawn in the first application
- Children with oncological disease, epilepsy, migraine, or vestibular disorder.
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 |
|---|---|---|
| InterventionAlso: Vibrating tourniquetVibrating tourniquet | Other | Group 1 |
| Distraction cardDistraction card | Other | Group 2 |
Primary outcome
change on pain intensity as measured by Visual Analog Scale
Time frame: "5-10 minutes before procedure", "during procedure" and "5 minutes after" blood collection process
It is a 10 cm or 100 mm long horizontal or vertical line with anchor statements "no pain or pain at its least" at the left-most end and "unbearable pain or worst pain imaginable" at the right-most end. The VAS score is determined by measuring (in cm) the distance of the mark from the left end of the line.
2 secondary outcomes
Score change on state anxiety level as measured by Child Anxiety Scale State Scale (ÇAS-D)
Time frame: "5-10 minutes before procedure" and "5 minutes after procedure" blood collection process
Score change on fear level as measured by Children's Fear Scale
Time frame: "5-10 minutes before procedure" and "5 minutes after procedure" blood collection process
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 7 Mar 2023.
- Background: PubMed 29728296Bergomi P, Scudeller L, Pintaldi S, Dal Molin A. Efficacy of Non-pharmacological Methods of Pain Management in Children Undergoing Venipuncture in a Pediatric Outpatient Clinic: A Randomized Controlled Trial of Audiovisual Distraction and External Cold and Vibration. J Pediatr Nurs. 2018 Sep-Oct;42:e66-e72. doi: 10.1016/j.pedn.2018.04.011. Epub 2018 May 1.
- Background: PubMed 28712986Bukola IM, Paula D. The Effectiveness of Distraction as Procedural Pain Management Technique in Pediatric Oncology Patients: A Meta-analysis and Systematic Review. J Pain Symptom Manage. 2017 Oct;54(4):589-600.e1. doi: 10.1016/j.jpainsymman.2017.07.006. Epub 2017 Jul 14.
- Background: PubMed 29559294Gerceker GO, Binay S, Bilsin E, Kahraman A, Yilmaz HB. Effects of Virtual Reality and External Cold and Vibration on Pain in 7- to 12-Year-Old Children During Phlebotomy: A Randomized Controlled Trial. J Perianesth Nurs. 2018 Dec;33(6):981-989. doi: 10.1016/j.jopan.2017.12.010. Epub 2018 Mar 17.
- Background: PubMed 33711642Diaz-Rodriguez M, Alcantara-Rubio L, Aguilar-Garcia D, Perez-Munoz C, Carretero-Bravo J, Puertas-Cristobal E. The Effect of Play on Pain and Anxiety in Children in the Field of Nursing: A Systematic Review. J Pediatr Nurs. 2021 Nov-Dec;61:15-22. doi: 10.1016/j.pedn.2021.02.022. Epub 2021 Mar 10.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Distraction card in people with Pain and Anxiety, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 6 inclusion and 2 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 7 Mar 2023. 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 Turkey (Türkiye). 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?
change on pain intensity as measured by Visual Analog Scale (time frame: "5-10 minutes before procedure", "during procedure" and "5 minutes after" blood collection process). 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 NCT05758584, which also lists 4 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 7 Mar 2023.