NCT05564260

Brief Summary

In literature review, many studies have been found to support the positive effects of various nonpharmacological methods in the alleviation of pain and fear created by invasive procedures.This study was carried out to determine the effects of kaleidoscope and cartoon watching using the virtual reality glasses on the pain and fear states of children during blood draw procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
Last Updated

October 3, 2022

Status Verified

September 1, 2022

Enrollment Period

6 months

First QC Date

September 28, 2022

Last Update Submit

September 28, 2022

Conditions

FearPain

Outcome Measures

Primary Outcomes (3)

  • Pain assesed by child, parent, nurse with Wong-Baker FACES

    Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst). Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst).

    during procedure

  • Pain assesed by Visual Analohg Scale (VAS)

    Visual Analog Scale (VAS): Visual Analog Scale, which is used to measure severity of pain consists of a horizontal or vertical ruler at a length of 10 cm or 100 mm which has "no pain" on one side and "the most severe pain possible" on the other side. While there is "no pain" expression on the left side of the ruler, there is "unberable pain" expression on the right side. VAS is described as understandable and easy-to-use for the children over 7 years old. Its validity and reliability have been shown in the previous studies

    during procedure

  • Fear assesed by The Children's Fear Scale (CFS)

    This is a one-item self-report scale which is used to measure pain-associated fear. This one-item scale is composed of five neutral faces in terms of sex. There is a face showing no fear on the left and a face showing extreme fear on the right. The response of the evaluator shows the level of fear. It can be used by the parents and researchers before and during the procedure for the children aged 5-10 years old

    during procedure

Study Arms (3)

The Kaleidescope Group

EXPERIMENTAL

Kaleidoscope was watched during blood drawing

Behavioral: Kaleidescope

The VR Group

EXPERIMENTAL

watching the application by wearing virtual glasses to the child during the blood drawing

Behavioral: Virtual Reality

Control Group

NO INTERVENTION

No intervention was made.

Interventions

KaleidescopeBEHAVIORAL

watching kaleidescope

Also known as: distraction methods
The Kaleidescope Group
Virtual RealityBEHAVIORAL

wearing virtual reality glasses

Also known as: distraction methods
The VR Group

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • being literate for the child and parent
  • being 7-12 years old
  • having no vision or hearing problems
  • having no chronic or mental health problem.

You may not qualify if:

  • the child with physical and psychological deficit to prevent him from wearing the glasses to be worn on his head so that he can watch virtual reality.
  • having vision or hearing problems
  • having chronic or mental health problem.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bafra State Hospital

Samsun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Esra Tural Buyuk

    Phd, RN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 28, 2022

First Posted

October 3, 2022

Study Start

January 1, 2020

Primary Completion

July 1, 2020

Study Completion

December 1, 2020

Last Updated

October 3, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)