Distraction Method on Pain and Anxiety During Circumcision

NCT ID: NCT04220346

Last Updated: 2020-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-12-27

Brief Summary

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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

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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.

Conditions

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Pain Anxiety Urological Nursing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Tablet group

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

Group Type EXPERIMENTAL

Tablet group

Intervention Type OTHER

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.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

OTHER

Sponsor Role lead

Responsible Party

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Elif Gezginci

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elif Gezginci, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri Universitesi

Locations

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University of Health Sciences

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 27294708 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22959557 (View on PubMed)

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.

Reference Type BACKGROUND

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

Reference Type BACKGROUND
PMID: 26526331 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22926180 (View on PubMed)

Other Identifiers

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2018-123

Identifier Type: -

Identifier Source: org_study_id

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