Distraction Method on Pain and Anxiety During Circumcision

Sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi (Other)

Overall Status

Completed

CT.gov ID

NCT04220346

Collaborator

(none)

Enrollment

Location

Arms

14.9

Actual Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Anxiety Urological Nursing	Other: Tablet group	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Oct 1, 2018

Actual Primary Completion Date :

Oct 31, 2019

Actual Study Completion Date :

Dec 27, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tablet group The Tablet group played the game with Tablet during the whole circumcision.	Other: Tablet group 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.
No Intervention: Control group The control group did not play game with Tablet during the procedure.

Arm

Intervention/Treatment

Experimental: Tablet group

The Tablet group played the game with Tablet during the whole circumcision.

Other: Tablet group

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.

No Intervention: Control group

The control group did not play game with Tablet during the procedure.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 12 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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