Distraction Method on Pain and Anxiety During Circumcision

Study Overview
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Brief Summary
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Circumcision is a common procedure in infants, children and young people around the world for cultural, religious or medical reasons. Since this is a painful procedure, it is performed under local anesthesia or general anesthesia. It is recommended to perform this procedure under local anesthesia if there is no risk. Although local anesthesia is used during the procedure, pain and anxiety levels of children may increase. Distraction methods are commonly used and effective methods to reduce pain and anxiety during painful procedures. The aim of this study was to evaluate the effect of tablet playing during circumcision on pain and anxiety in school age children.

Detailed Description
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Circumcision is a common procedure in the worldwide. To our knowledge, although there have been several randomized controlled trials using video and game techniques, which are distractions to reduce pain and anxiety during painful procedures, no randomized controlled trials using playing the game with Tablet to reduce pain and anxiety during circumcision have been found. Non-pharmacological studies, such as play therapy, are needed to reduce pain and anxiety in school-age children undergoing circumcision under local anesthesia. The aim of this study is to provide evidence about the effectiveness of playing the game with Tablet used to reduce pain and anxiety during circumcision, and to contribute to nursing care in pain management.

Official Title
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The Effect of Playing Games With Tablet on Pain and Anxiety During Circumcision in Children: A Randomized Controlled Study

Conditions
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Pain, Anxiety, Urological Nursing

Intervention / Treatment
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* Other: Tablet group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: being between 7-12 years male gender circumcision with local anesthesia agreeing to participate in the study Exclusion Criteria: presence of any contraindication for circumcision (hemophilia, bleeding disorders, urinary anatomical disorders-hypospadias, epispadias etc.) any analgesic used 24 hours before circumcision

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tablet group<br>The Tablet group played the game with Tablet during the whole circumcision. | Other: Tablet group<br>* Children in the Tablet group started to play the game with Tablet about 5-10 minutes before circumcision, and continued to play the game during the whole procedure.<br>|
| No Intervention: Control group<br>The control group did not play game with Tablet during the procedure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change on pain intensity as measured by Visual Analog Scale | The average score change on pain intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure pain intensity. The scale is a measuring tool with length of 0-10 cm (0-100 mm). High scores on the scale indicate that pain intensity is high. | 5-10 minutes before procedure, during procedure and 5 minutes after circumcision. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score change on anxiety level as measured by State-Trait Anxiety Inventory for Children | The average score change on anxiety level as measured by State-Trait Anxiety Inventory for Children. This scale is used to measure anxiety. The scores on the scale ranges from 20 to 60. The high scores on the scale indicate that anxiety is high. | 5-10 minutes before procedure and 5 minutes after procedure circumcision. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety, children, circumcision, nursing, pain