Comparison of the Effectiveness of Distraction

Venipuncture Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04983303
• Other study ID #: SRS
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: July 2021
• Source: University of Witten/Herdecke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• School-aged 6-12 years old.

• Children who require venipuncture.

Exclusion Criteria:

1. Respiratory chronic diseases,

2. Physical impairment,

3. Disability contributing to difficult communication,

4. Children of unsatisfied parents,

5. Children with neurodevelopment delay,

6. Cognitive impairment, hearing impairment or a visual impairment,

7. Taking an analgesic within 6 hours, or for those with a syncope history.

Related Conditions & MeSH terms

• Venipuncture

Intervention

Other:
• TICK-B group
These interventions will distract the child during venipuncture

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Witten/Herdecke

References & Publications (8)

Gupta 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. — View Citation

Koller 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. Review. — View Citation

Rogers TL, Ostrow CL. The use of EMLA cream to decrease venipuncture pain in children. J Pediatr Nurs. 2004 Feb;19(1):33-9. Review. — View Citation

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. — View Citation

Taddio 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. Review. — View Citation

Usichenko 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):343-5, table of contents. — View Citation

Wallace 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. — View Citation

Walther-Larsen S, Pedersen MT, Friis SM, Aagaard GB, Rømsing 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visual Analog Scale (VAS), to measure the pain and Fear of children by the parents and observer.	Visual Analog Scale (VAS) will be used to measure pain and fear of children during venipuncture by parent and observer	Immediately after venipuncture (1-2 min.)
Primary	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.	5 minutes before procedure done.
Primary	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.	5 minutes before venipuncture procedure done
Secondary	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.	0 minute during venipuncture procedure (time during insertion of cannula).
Secondary	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.	1-2 minute after venipuncture procedure done.
Secondary	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.	0 minute during venipuncture procedure.
Secondary	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.	1-2 minute after venipuncture procedure done.