Comparison Effectiveness of Distractions on Pain and Fear of Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Peripheral Intravenous Cannulation

Intervention / Treatment
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* Other: TICK-B group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: School-aged 6-12 years old. Children who require PIVC. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TICK-B group as intervention group<br>TICK-B group: The children will receive the pictures they want. They will be asked to trace and color the pictures that need coloring. The nurse will color with children during the procedure. And after the procedure, the child will take his or her picture which he colored during the procedure. | Other: TICK-B group<br>* These interventions will use as distraction techniques.<br>* Other names: Watching cartoons;|
| Experimental: Watching cartoons<br>Watching cartoons: In this group, children will watch cartoons as they like. Watching will continue until the procedure is complete. | Other: TICK-B group<br>* These interventions will use as distraction techniques.<br>* Other names: Watching cartoons;|
| Experimental: Group listening to music<br>Listening to music: In this group, children will listen to cartoon music as they like. Listen will continue until the procedure is complete. | Other: TICK-B group<br>* These interventions will use as distraction techniques.<br>* Other names: Watching cartoons;|
| No Intervention: Standard care provided group as control group<br>Control group. The kids in this group will be allowed to keep their family near. The routine blood taking | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Peripheral intravenous cannulation 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. | 
| Children's Fear Scale (CFS): Fear (0-4) no anxiety to extreme anxiety | To assess the fear level of the children related to Peripheral intravenous cannulation 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 procedure done | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Peripheral intravenous cannulation 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 peripheral cannulation insertion 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 peripheral intravenous cannulation 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 minutes after 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 peripheral intravenous cannulation 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 cannulation procedure. | 
| Children's Fear Scale (CFS): Fear (0-4) no anxiety to extreme anxiety | To assess the fear level of the children related to peripheral intravenous cannulation 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 cannulation procedure done. |