NCT04220346

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

1.1 years

First QC Date

January 5, 2020

Last Update Submit

January 6, 2020

Conditions

PainAnxietyUrological Nursing

Keywords

anxietychildrencircumcisionnursingpain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Study Arms (2)

Tablet group

EXPERIMENTAL

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

Other: Tablet group

Control group

NO INTERVENTION

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

Interventions

Tablet groupOTHER

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.

Tablet group

Eligibility Criteria

Age7 Years - 12 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • being between 7-12 years
  • male gender
  • circumcision with local anesthesia
  • agreeing to participate in the study

You may not qualify if:

  • presence of any contraindication for circumcision (hemophilia, bleeding disorders, urinary anatomical disorders-hypospadias, epispadias etc.)
  • any analgesic used 24 hours before circumcision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    BACKGROUND

  • 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.

    PMID: 27294708BACKGROUND

  • 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.

    PMID: 22959557BACKGROUND

  • 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.

    BACKGROUND

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

    PMID: 26526331BACKGROUND

  • 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.

    PMID: 22926180BACKGROUND

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Elif Gezginci, RN, PhD

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 5, 2020

First Posted

January 7, 2020

Study Start

October 1, 2018

Primary Completion

October 31, 2019

Study Completion

December 27, 2019

Last Updated

January 7, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)