Distraction Method on Pain and Anxiety During Circumcision

Not Applicable

Completed

• Conditions: Anxiety; Pain; Urological Nursing
• Interventions: Other: Tablet group

• Registration Number: NCT04220346
• Lead Sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2019-10-31
• Study Completion: 2019-12-27
• Status Verified: 2020-01
• Study First Submitted: 2020-01-05
• Study First Submitted QC: 2020-01-06
• Last Update Submitted: 2020-01-06
• Study First Posted: 2020-01-07
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tablet group	Tablet group	The Tablet group played the game with Tablet during the whole circumcision.

Primary Outcome Measures

Name	Time	Method
change on pain intensity as measured by Visual Analog Scale	"5-10 minutes before procedure", "during procedure" and "5 minutes after" circumcision.	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.

Secondary Outcome Measures

Name	Time	Method
score change on anxiety level as measured by State-Trait Anxiety Inventory for Children	"5-10 minutes before procedure" and "5 minutes after procedure" circumcision.	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.

Trial Locations

Locations (1)

University of Health Sciences; 🇹🇷 Istanbul, Turkey