Pain Clinical Trial
Official title:
Effect Of Distraction Methods On Procedure-Related Fear, Anxiety, And Pain During Intramuscular Injection in Pediatric Emergency Department
Verified date | July 2022 |
Source | Dokuz Eylul University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Buzzy, shot-blocker, distraction cards, and balloon blowing can reduce fear and pain during the intramuscular intervention in the pediatric emergency service unit. This study aimed to evaluate the effect of virtual reality, manual pressure vibration technique, and cold vibration device application on procedure-related pain, fear, and anxiety during intramuscular antibiotics in children aged 5-12 years in the pediatric emergency department.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 30, 2022 |
Est. primary completion date | December 29, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years to 12 Years |
Eligibility | Inclusion Criteria: - Children are between the ages of 5-12 - Intramuscular antibiotics (penicillin, ceftriaxone, amikacin etc.) to be administered - The intervention will be applied from the gluteal region - The child agrees to voluntarily participate in the study. - Parents agree to voluntarily participate in the study - Obtaining consent form from the child and parent Exclusion Criteria: - child with a physical and psychological deficit to prevent him from wearing the glasses to be worn on his head so that he can watch virtual reality. - child with sedative or analgesic medication. - child with a neurodegenerative disease, mental retardation, vision and hearing problems, chronic, life-threatening (sepsis, shock, respiratory / cardiac arrest) or genetic disease |
Country | Name | City | State |
---|---|---|---|
Turkey | Gülçin Özalp Gerçeker | Izmir |
Lead Sponsor | Collaborator |
---|---|
Dokuz Eylul University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain assesed by Wong-Baker FACES | Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst). | procedure (during the intramuscular injection) | |
Primary | Anxiety assesed by Children Anxiety Meter-State | The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). This scale ranges from 0 to 10. Higher values represent higher anxiety | procedure (during the intramuscular injection) | |
Primary | Fear assesed by Child Fear Scale | The Child Fear Scale (CFS). The Child Fear Scale will use.This one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear. This rating scale ranges from 0 to 4. It ranges from a no fear (neutral) face (0) on the far left to a face showing extreme fear on the far right. Higher scores mean a worse outcome. The rater responds indicates the level of fear. It can be used during the procedure for children aged 5-10 years. | procedure (during the intramuscular injection) | |
Secondary | Emotional Appearance Scale for Children | This scale allows direct behavioral observation, consists of 5 different behavioral categories; 'Facial Expression', 'Speaking', 'Activity', 'Interaction' and 'Cooperation Level'. Scale scoring is done by reviewing the descriptions of behavior in each category and selecting the numerical value that most represents the observed behavior. Each category is scored from 1 to 5. The total score is made so that the numerical value is between 5-25 by adding the points obtained for each category. Higher scale score indicates the appearance of more negative emotional behaviors. |
Baseline (before the intramuscular injection) |
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