Clinical trial NCT04977323: Comparison Effectiveness of Distractions on Pain and Fear of Children
Official title: Comparing The Effectiveness of Tracing Image and Coloring for Kids-Book With Two Passive Distractions on Pain and Fear in Children During Peripheral Intravenous Cannulation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Intravenous Cannulation
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
First posted: 2021-07-26
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: OTHER

Brief summary: Distraction is a non-pharmacological technique that moves focus away from anxiety, discomfort or unpleasant stimulation to more stimulating or friendly stimulation. Distraction is one of the most effective, simplest and inexpensive non-pharmacological pain management methods (Hockenberry \& Wilson, 2018). The benefits of using non-pharmacological methods include decreased pain, distress, and fear reported by the parent, child, and/or observer (Wente, 2013). There are two main types of distraction techniques: active and passive (Mutlu \& Balcı, 2015; Wohlheiter \& Dahlquist, 2013).

Objectives:

To evaluate the roles of the TICK-B, listening music, and watching cartoon, in relieving pain and fear of school-age children during PIVC.

To compare the effect of TICK-B with the effects of the listening music, and watching cartoon, on reducing pain and fear during PIVC in children.

To compare the effects of three distraction groups with the control group in relieving pain and fear during PIVC.

Detailed description: Peripheral intravenous cannulation (PIVC) is an invasive technique. In this technique, a catheter is entrenched through the skin of the recipient into the lumen of a peripheral blood vein. It is the second most painful procedure performed in hospitals. Peripheral intravenous cannulation (PICV) is a common painful procedure for children, and nearly all ill children have experience with PIVC, and up to 80% of patients receive a peripheral venous cannula in a hospital. Therefore, the use of effective methods in pain and anxiety relief is very important during injection procedures in children.

In order to relieve pain and fear in children undergoing PICV. Psychological and physical approaches for coping with children's pain are favored, as well as pharmacological methods. Application of topical anesthetic creams is the most commonly used pharmacological solution to reduce pain associated with the medical procedure, or refrigerant preparations, however, only reduce the perception of pain in children during procedures. These approaches are not resolved anxiety, a core factor of noncooperation, which encumbers the efficiency of the needle procedure. For this cause, non-pharmacological approaches are generally recognized as alternative techniques, which may be used separately or in addition to pharmacological approaches, to provide sufficient pain and fear relief and to offer children a sense of control over the situation.

Eligibility criteria: Inclusion Criteria:

* School-aged 6-12 years old.
* Children who require PIVC.

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: Children's Fear Scale (CFS): Fear (0-4) no anxiety to extreme anxiety
timeFrame: 5 minutes before 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 peripheral cannulation insertion 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 minutes after procedure done.
measure: Children's Fear Scale (CFS): Fear (0-4) no anxiety to extreme anxiety
timeFrame: 0 minute during cannulation procedure.
measure: Children's Fear Scale (CFS): Fear (0-4) no anxiety to extreme anxiety
timeFrame: 1-2 minute after cannulation 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 cannualtion (1-2 minutes after procedure to mask observer)
Locations:
Study officials:
References:
citation: Hockenberry, M. J., & Wilson, D. (2018). Wong's nursing care of infants and children-E-book. Elsevier Health Sciences.
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citation: Mutlu B, Balci S. Effects of balloon inflation and cough trick methods on easing pain in children during the drawing of venous blood samples: a randomized controlled trial. J Spec Pediatr Nurs. 2015 Jul;20(3):178-86. doi: 10.1111/jspn.12112. Epub 2015 Mar 28.
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citation: Friedrichsdorf, Stefan J., Donna Eull, and C. A. Weidner.
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citation: Uman LS, Chambers CT, McGrath PJ, Kisely S. A systematic review of randomized controlled trials examining psychological interventions for needle-related procedural pain and distress in children and adolescents: an abbreviated cochrane review. J Pediatr Psychol. 2008 Sep;33(8):842-54. doi: 10.1093/jpepsy/jsn031. Epub 2008 Apr 2.