VenipunctureNCT04983303
Comparison of the Effectiveness of Distraction
A study testing TICK-B group in people with Venipuncture, run by University of Witten/Herdecke.
Trial summary
Venipuncture, a frequently performed needle-related procedure, is one of the foremost frightening experiences, and a typical source of moderate to severe pain for pediatric patients. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Venipuncture
- What is being tested?
- TICK-B group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 1 Oct 2021
- 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
- School-aged 6-12 years old.
- Children who require venipuncture.
Who cannot join
- Respiratory chronic diseases,
- Physical impairment,
- Disability contributing to difficult communication,
- Children of unsatisfied parents,
- Children with neurodevelopment delay,
- Cognitive impairment, hearing impairment or a visual impairment,
- Taking an analgesic within 6 hours, or for those with a syncope history.
About this study
Official title: Comparing The Effectiveness of Tracing Image and Coloring for Kids-Book With Two Active Distractions on Pain and Fear in Children During Venipuncture: A Randomized Controlled Trial
Venipuncture, a frequently performed needle-related procedure, is one of the foremost frightening experiences, and a typical source of moderate to severe pain for pediatric patients.
No randomized studies have compared the effectiveness of balloon inflation, cough trick, and TICK-B on reducing pain in children between 6 and 12 years old during the drawing of venous blood samples. The research hypothesis was that children who draw and color a picture, inflate a balloon, or perform the cough trick while having their blood taken would experience less pain and anxiety than children who did not undergo a pain-reducing intervention.
Read more
Objectives:
To evaluate the roles of the TICK-B, balloon inflation, and cough trick in relieving pain and fear of school-age children during venipuncture.
To compare the effect of TICK-B with the effects of the cough trick, balloon inflation, on reducing pain and anxiety during venipuncture in children.
To compare the effects of three distraction groups with the control group in relieving pain and anxiety during venipuncture.
Read the detailed description
Venipuncture, a frequently performed needle-related procedure, is one of the foremost frightening experiences, and a typical source of moderate to severe pain for pediatric patients. Approximately 83% of young children aged 2.5-6 years, 51% of youngsters aged 7-12 years, and 28% of adolescents (aged more than 12 years) who underwent venipuncture stated high levels of distress during the painful procedure. However, < 10% of venipuncture performing are given pain management.
To relieve pain, fear, and anxiety in children undergoing venipuncture or venous cannulation, both pharmacological and non-pharmacological approaches are used to help control pediatric patients' discomfort. Pain management includes pharmacologic and non-pharmacologic approaches. The most commonly used pharmacological approach to decrease medical procedure-related pain is the application of topical anesthetic creams. Non-pharmacological methods include distraction actions like blowing bubbles, reading, or playing a game.
Balloon inflation causes a reduction in venous return with increased intrathoracic pressure. It has been speculated that this increase in pressure induces baroreceptor activation with contraction of the pulmonary vessels and that the activation of cardiopulmonary and sinoaortic baroreceptor reflex arcs has an antinociceptive effect, resulting in pain relief.
Coughing increases intrathoracic pressure and stimulation to the autonomic nervous system, causing an increase in heart rate and blood pressure, a higher level of pressure in the subarachnoid space, and baroreceptor activation. The increase in pressure in the subarachnoid space activates the segmental pain inhibiting pathways; thus, the increase in blood pressure and baroreceptor activation appears to be efficacious in reducing the perception of pain.
- Conditions
- Venipuncture
- Being tested
- TICK-B group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TICK-B groupOther
Also called Coughing trick group, Balloon inflation group, Control group or no intervention
These interventions will distract the child during venipuncture
| Study group | Role | What they receive |
|---|---|---|
| TICK-B group as intervention group | Experimental | TICK-B group: The children will receive a picture as they want. They will be asked to trace and color the pictures that need coloring. After the procedure, the child will take his or her picture which he colored during the procedure. Receives: Other: TICK-B group |
| Coughing trick | Experimental | Coughing trick: Children in this group will be taught how to cough during the procedure. coughs with start moderate force and then coughs again which coincides with a needle procedure, such as venipuncture for example. Receives: Other: TICK-B group |
| Balloon inflation group as intervention group | Experimental | Balloon inflation group: In this group, the children will receive a balloon colored as their favorite, and they will be asked to inflate the balloon before starting the venipuncture procedure. Receives: Other: TICK-B group |
| Standard care provided group as control group | No intervention | Standard care provided group as the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain
To assess the intensity of pain related to the venipuncture procedure in children.
Children will self-report their pain severity using the Faces Pain Scale-Revised, which has been validated and shown to be reliable.
Measured: 5 minutes before procedure done.
Fear
To assess the fear level of the children related to the venipuncture procedure.
Children will self-report their level of fear using the Children's Fear Scale (CFS), which has been validated and shown to be reliable.
Measured: 5 minutes before venipuncture procedure done
Secondary outcomes (4)
Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain
To assess the intensity of pain related to venipuncture procedure in children:
Children will self-report their pain severity using the Faces Pain Scale-Revised, which has been validated and shown to be reliable.
Measured: 0 minute during venipuncture procedure (time during insertion of cannula).
Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain.
To assess the intensity of pain related to the venipuncture procedure in children.
Children will self-report their pain severity using the Faces Pain Scale-Revised, which has been validated and shown to be reliable.
Measured: 1-2 minute after venipuncture procedure done.
Children's Fear Scale (CFS): Fear (0-4) no anxiety to extreme anxiety
To assess the fear level of the children related to venipuncture procedure:
-Children will self-report their level of fear using the Children's Fear Scale (CFS), which has been validated and shown to be reliable.
Measured: 0 minute during venipuncture procedure.
Children's Fear Scale (CFS): Fear (0-4) no anxiety to extreme anxiety
To assess the fear level of the children related to the venipuncture procedure:
-Children will self-report their level of fear using the Children's Fear Scale (CFS), which has been validated and shown to be reliable.
Measured: 1-2 minute after venipuncture procedure done.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for VenipunctureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Witten/Herdecke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherzad Khudeida Suleman, University of Witten/Herdecke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983303
- Sponsor's protocol ID
- SRS
- Status last verified
- Jul 2021
- First submitted
- 4 Jul 2021
- Last updated
- 30 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stevens BJ, Abbott LK, Yamada J, Harrison D, Stinson J, Taddio A, Barwick M, Latimer M, Scott SD, Rashotte J, Campbell F, Finley GA; CIHR Team in Children's Pain. Epidemiology and management of painful procedures in children in Canadian hospitals. CMAJ. 2011 Apr 19;183(7):E403-10. doi: 10.1503/cmaj.101341. Epub 2011 Apr 4.
PubMed 21464171Walther-Larsen S, Pedersen MT, Friis SM, Aagaard GB, Romsing J, Jeppesen EM, Friedrichsdorf SJ. Pain prevalence in hospitalized children: a prospective cross-sectional survey in four Danish university hospitals. Acta Anaesthesiol Scand. 2017 Mar;61(3):328-337. doi: 10.1111/aas.12846. Epub 2016 Dec 29.
PubMed 28032329Taddio A, Appleton M, Bortolussi R, Chambers C, Dubey V, Halperin S, Hanrahan A, Ipp M, Lockett D, MacDonald N, Midmer D, Mousmanis P, Palda V, Pielak K, Riddell RP, Rieder M, Scott J, Shah V. Reducing the pain of childhood vaccination: an evidence-based clinical practice guideline (summary). CMAJ. 2010 Dec 14;182(18):1989-95. doi: 10.1503/cmaj.092048. Epub 2010 Nov 22. No abstract available.
PubMed 21098067Rogers TL, Ostrow CL. The use of EMLA cream to decrease venipuncture pain in children. J Pediatr Nurs. 2004 Feb;19(1):33-9. doi: 10.1016/j.pedn.2003.09.005.
PubMed 14963868Koller D, Goldman RD. Distraction techniques for children undergoing procedures: a critical review of pediatric research. J Pediatr Nurs. 2012 Dec;27(6):652-81. doi: 10.1016/j.pedn.2011.08.001. Epub 2011 Oct 13.
PubMed 21925588Gupta D, Agarwal A, Dhiraaj S, Tandon M, Kumar M, Singh RS, Singh PK, Singh U. An evaluation of efficacy of balloon inflation on venous cannulation pain in children: a prospective, randomized, controlled study. Anesth Analg. 2006 May;102(5):1372-5. doi: 10.1213/01.ane.0000205741.82299.d6.
PubMed 16632812Usichenko TI, Pavlovic D, Foellner S, Wendt M. Reducing venipuncture pain by a cough trick: a randomized crossover volunteer study. Anesth Analg. 2004 Feb;98(2):343-345. doi: 10.1213/01.ANE.0000094983.16741.AF.
PubMed 14742367Wallace DP, Allen KD, Lacroix AE, Pitner SL. The "cough trick:" a brief strategy to manage pediatric pain from immunization injections. Pediatrics. 2010 Feb;125(2):e367-73. doi: 10.1542/peds.2009-0539. Epub 2010 Jan 11.
PubMed 20064862
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing The Effectiveness of Tracing Image and Coloring for Kids-Book With Two Active Distractions on Pain and Fear in Children During Venipuncture: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04983303
- Acronym / sponsor ID
- SRS
- Conditions
- Venipuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Witten/HerdeckeUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 30 Jul 2021 (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.
Venipuncture, a frequently performed needle-related procedure, is one of the foremost frightening experiences, and a typical source of moderate to severe pain for pediatric patients.
No randomized studies have compared the effectiveness of balloon inflation, cough trick, and TICK-B on reducing pain in children between 6 and 12 years old during the drawing of venous blood samples. The research hypothesis was that children who draw and color a picture, inflate a balloon, or perform the cough trick while having their blood taken would experience less pain and anxiety than children who did not undergo a pain-reducing intervention.
Objectives:
To evaluate the roles of the TICK-B, balloon inflation, and cough trick in relieving pain and fear of school-age children during venipuncture.
To compare the effect of TICK-B with the effects of the cough trick, balloon inflation, on reducing pain and anxiety during venipuncture in children.
To compare the effects of three distraction groups with the control group in relieving pain and anxiety during venipuncture.
Detailed description
Venipuncture, a frequently performed needle-related procedure, is one of the foremost frightening experiences, and a typical source of moderate to severe pain for pediatric patients. Approximately 83% of young children aged 2.5-6 years, 51% of youngsters aged 7-12 years, and 28% of adolescents (aged more than 12 years) who underwent venipuncture stated high levels of distress during the painful procedure. However, < 10% of venipuncture performing are given pain management.
To relieve pain, fear, and anxiety in children undergoing venipuncture or venous cannulation, both pharmacological and non-pharmacological approaches are used to help control pediatric patients' discomfort. Pain management includes pharmacologic and non-pharmacologic approaches. The most commonly used pharmacological approach to decrease medical procedure-related pain is the application of topical anesthetic creams. Non-pharmacological methods include distraction actions like blowing bubbles, reading, or playing a game.
Balloon inflation causes a reduction in venous return with increased intrathoracic pressure. It has been speculated that this increase in pressure induces baroreceptor activation with contraction of the pulmonary vessels and that the activation of cardiopulmonary and sinoaortic baroreceptor reflex arcs has an antinociceptive effect, resulting in pain relief.
Coughing increases intrathoracic pressure and stimulation to the autonomic nervous system, causing an increase in heart rate and blood pressure, a higher level of pressure in the subarachnoid space, and baroreceptor activation. The increase in pressure in the subarachnoid space activates the segmental pain inhibiting pathways; thus, the increase in blood pressure and baroreceptor activation appears to be efficacious in reducing the perception of pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TICK-B group as intervention group | Experimental | Other: TICK-B groupTICK-B group: The children will receive a picture as they want. They will be asked to trace and color the pictures that need coloring. After the procedure, the child will take his or her picture which he colored during the procedure. |
| Coughing trick | Experimental | Other: TICK-B groupCoughing trick: Children in this group will be taught how to cough during the procedure. coughs with start moderate force and then coughs again which coincides with a needle procedure, such as venipuncture for example. |
| Balloon inflation group as intervention group | Experimental | Other: TICK-B groupBalloon inflation group: In this group, the children will receive a balloon colored as their favorite, and they will be asked to inflate the balloon before starting the venipuncture procedure. |
| Standard care provided group as control group | No intervention | –Standard care provided group as the control group |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- School-aged 6-12 years old.
- Children who require venipuncture.
Key exclusion criteria (7 listed)
- Respiratory chronic diseases,
- Physical impairment,
- Disability contributing to difficult communication,
- Children of unsatisfied parents,
- Children with neurodevelopment delay,
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 |
|---|---|---|
| TICK-B groupAlso: Coughing trick group, Balloon inflation group, Control group or no interventionThese interventions will distract the child during venipuncture | Other | Balloon inflation group as intervention group, Coughing trick, TICK-B group as intervention group |
Primary outcome
Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain
Time frame: 5 minutes before procedure done.
To assess the intensity of pain related to the venipuncture procedure in children. Children will self-report their pain severity using the Faces Pain Scale-Revised, which has been validated and shown to be reliable.
Fear
Time frame: 5 minutes before venipuncture procedure done
To assess the fear level of the children related to the venipuncture procedure. Children will self-report their level of fear using the Children's Fear Scale (CFS), which has been validated and shown to be reliable.
4 secondary outcomes
Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain
Time frame: 0 minute during venipuncture procedure (time during insertion of cannula).
Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain.
Time frame: 1-2 minute after venipuncture procedure done.
Children's Fear Scale (CFS): Fear (0-4) no anxiety to extreme anxiety
Time frame: 0 minute during venipuncture procedure.
Children's Fear Scale (CFS): Fear (0-4) no anxiety to extreme anxiety
Time frame: 1-2 minute after venipuncture procedure done.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Background: PubMed 21464171Stevens BJ, Abbott LK, Yamada J, Harrison D, Stinson J, Taddio A, Barwick M, Latimer M, Scott SD, Rashotte J, Campbell F, Finley GA; CIHR Team in Children's Pain. Epidemiology and management of painful procedures in children in Canadian hospitals. CMAJ. 2011 Apr 19;183(7):E403-10. doi: 10.1503/cmaj.101341. Epub 2011 Apr 4.
- Background: PubMed 28032329Walther-Larsen S, Pedersen MT, Friis SM, Aagaard GB, Romsing J, Jeppesen EM, Friedrichsdorf SJ. Pain prevalence in hospitalized children: a prospective cross-sectional survey in four Danish university hospitals. Acta Anaesthesiol Scand. 2017 Mar;61(3):328-337. doi: 10.1111/aas.12846. Epub 2016 Dec 29.
- Background: PubMed 21098067Taddio A, Appleton M, Bortolussi R, Chambers C, Dubey V, Halperin S, Hanrahan A, Ipp M, Lockett D, MacDonald N, Midmer D, Mousmanis P, Palda V, Pielak K, Riddell RP, Rieder M, Scott J, Shah V. Reducing the pain of childhood vaccination: an evidence-based clinical practice guideline (summary). CMAJ. 2010 Dec 14;182(18):1989-95. doi: 10.1503/cmaj.092048. Epub 2010 Nov 22. No abstract available.
- Background: PubMed 14963868Rogers TL, Ostrow CL. The use of EMLA cream to decrease venipuncture pain in children. J Pediatr Nurs. 2004 Feb;19(1):33-9. doi: 10.1016/j.pedn.2003.09.005.
- Background: PubMed 21925588Koller D, Goldman RD. Distraction techniques for children undergoing procedures: a critical review of pediatric research. J Pediatr Nurs. 2012 Dec;27(6):652-81. doi: 10.1016/j.pedn.2011.08.001. Epub 2011 Oct 13.
- Background: PubMed 16632812Gupta D, Agarwal A, Dhiraaj S, Tandon M, Kumar M, Singh RS, Singh PK, Singh U. An evaluation of efficacy of balloon inflation on venous cannulation pain in children: a prospective, randomized, controlled study. Anesth Analg. 2006 May;102(5):1372-5. doi: 10.1213/01.ane.0000205741.82299.d6.
- Background: PubMed 14742367Usichenko TI, Pavlovic D, Foellner S, Wendt M. Reducing venipuncture pain by a cough trick: a randomized crossover volunteer study. Anesth Analg. 2004 Feb;98(2):343-345. doi: 10.1213/01.ANE.0000094983.16741.AF.
- Background: PubMed 20064862Wallace DP, Allen KD, Lacroix AE, Pitner SL. The "cough trick:" a brief strategy to manage pediatric pain from immunization injections. Pediatrics. 2010 Feb;125(2):e367-73. doi: 10.1542/peds.2009-0539. Epub 2010 Jan 11.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing TICK-B group in people with Venipuncture, run by University of Witten/Herdecke.
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 7 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: status not confirmed, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain (time frame: 5 minutes before procedure done.). 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 NCT04983303, which also lists 8 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 30 Jul 2021.