Clinical trial NCT04220346: Distraction Method on Pain and Anxiety During Circumcision
Official title: The Effect of Playing Games With Tablet on Pain and Anxiety During Circumcision in Children: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Urological Nursing
Keywords: anxiety
children
circumcision
nursing
pain
Lead sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 70
Sex: MALE
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: change on pain intensity as measured by Visual Analog Scale
timeFrame: "5-10 minutes before procedure", "during procedure" and "5 minutes after" circumcision.
Secondary outcomes:
measure: score change on anxiety level as measured by State-Trait Anxiety Inventory for Children
timeFrame: "5-10 minutes before procedure" and "5 minutes after procedure" circumcision.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: University of Health Sciences
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Elif Gezginci, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
citation: Wilson-Smith EM. Procedural Pain Management in Neonates, Infants and Children. Rev Pain. 2011 Sep;5(3):4-12. doi: 10.1177/204946371100500303.
citation: 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.