search
Back to results

Distraction Method on Pain and Anxiety During Circumcision

Primary Purpose

Pain, Anxiety, Urological Nursing

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Tablet group
Sponsored by
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pain focused on measuring anxiety, children, circumcision, nursing, pain

Eligibility Criteria

7 Years - 12 Years (Child)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tablet group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 5, 2020
Last Updated
January 6, 2020
Sponsor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
search

1. Study Identification

Unique Protocol Identification Number
NCT04220346
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
December 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety, Urological Nursing
Keywords
anxiety, children, circumcision, nursing, pain

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tablet group
Arm Type
Experimental
Arm Description
The Tablet group played the game with Tablet during the whole circumcision.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group did not play game with Tablet during the procedure.
Intervention Type
Other
Intervention Name(s)
Tablet group
Intervention Description
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.
Primary Outcome Measure Information:
Title
change on pain intensity as measured by Visual Analog Scale
Description
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.
Time Frame
"5-10 minutes before procedure", "during procedure" and "5 minutes after" circumcision.
Secondary Outcome Measure Information:
Title
score change on anxiety level as measured by State-Trait Anxiety Inventory for Children
Description
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.
Time Frame
"5-10 minutes before procedure" and "5 minutes after procedure" circumcision.

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Gezginci, RN, PhD
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Health Sciences
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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.
Results Reference
background
PubMed Identifier
27294708
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.
Results Reference
background
PubMed Identifier
22959557
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
26526331
Citation
Wilson-Smith EM. Procedural Pain Management in Neonates, Infants and Children. Rev Pain. 2011 Sep;5(3):4-12. doi: 10.1177/204946371100500303.
Results Reference
background
PubMed Identifier
22926180
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.
Results Reference
background

Learn more about this trial

Distraction Method on Pain and Anxiety During Circumcision

We'll reach out to this number within 24 hrs