Clinical trial NCT04983303: Comparison of the Effectiveness of Distraction
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Venipuncture
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain
timeFrame: 5 minutes before procedure done.
measure: Fear
timeFrame: 5 minutes before venipuncture procedure done
Secondary outcomes:
measure: Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain
timeFrame: 0 minute during venipuncture procedure (time during insertion of cannula).
measure: Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain.
timeFrame: 1-2 minute after venipuncture procedure done.
measure: Children's Fear Scale (CFS): Fear (0-4) no anxiety to extreme anxiety
timeFrame: 0 minute during venipuncture procedure.
measure: Children's Fear Scale (CFS): Fear (0-4) no anxiety to extreme anxiety
timeFrame: 1-2 minute after venipuncture procedure done.
Other outcomes:
measure: Visual Analog Scale (VAS), to measure the pain and Fear of children by the parents and observer.
timeFrame: Immediately after venipuncture (1-2 min.)
Locations:
Study officials:
References:
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citation: 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. doi: 10.1213/01.ane.0000205741.82299.d6.
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):343-345. doi: 10.1213/01.ANE.0000094983.16741.AF.
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.