Distraction Method on Pain and Anxiety During Circumcision

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04220346
• Other study ID #: 2018-123
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 27, 2019

Study information

• Verified date: January 2020
• Source: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 27, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 7 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain
• Urological Nursing

Intervention

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.

Locations

Country	Name	City	State
Turkey	University of Health Sciences	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

American Academy of Pediatrics Task Force on Circumcision. Circumcision policy statement. Pediatrics. 2012 Sep;130(3):585-6. doi: 10.1542/peds.2012-1989. Epub 2012 Aug 27. — View Citation

Hussein HA. Effect of active and passive distraction on decreasing pain associated with painful medical procedures among school aged children. World Journal of Nursing Sciences 1(2): 13-23, 2015.

Liguori S, Stacchini M, Ciofi D, Olivini N, Bisogni S, Festini F. Effectiveness of an App for Reducing Preoperative Anxiety in Children: A Randomized Clinical Trial. JAMA Pediatr. 2016 Aug 1;170(8):e160533. doi: 10.1001/jamapediatrics.2016.0533. Epub 2016 Aug 1. — View Citation

Polat F, Tuncel A, Balci M, Aslan Y, Sacan O, Kisa C, Kayali M, Atan A. Comparison of local anesthetic effects of lidocaine versus tramadol and effect of child anxiety on pain level in circumcision procedure. J Pediatr Urol. 2013 Oct;9(5):670-4. doi: 10.1016/j.jpurol.2012.07.022. Epub 2012 Sep 7. — View Citation

Rizalar S, Tural Buyuk E, Yildirim N. Children's perspectives on the medical and cultural aspects of circumcision. Iranian Journal of Pediatrics 27(2): 1-7, 2017.

Wilson-Smith EM. Procedural Pain Management in Neonates, Infants and Children. Rev Pain. 2011 Sep;5(3):4-12. doi: 10.1177/204946371100500303. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.