NCT05319210

Brief Summary

The purpose of this research; This is a randomized controlled experimental study planned to examine the effect of virtual reality glasses and buzzy application on pain management during venous catheter insertion in children.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

April 8, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

March 21, 2022

Last Update Submit

March 31, 2022

Conditions

Keywords

painvirtual reality glassesbuzzy applicationchildrenvenous catheter

Outcome Measures

Primary Outcomes (1)

  • Pain management

    Management of pain during venous catheter insertion in children. The parameter for pain management will be determined by the Wong Baker Faces Pain Rating Scale.

    4 month

Secondary Outcomes (2)

  • Management of fear in children

    4 month

  • Management of anxiety in children

    4 month

Study Arms (3)

Buzzy application

EXPERIMENTAL

It is fixed on the right upper arm area of the child one minute before the procedure. After cleaning the skin with the appropriate solution, venous catheter placement will be performed. During the procedure, the child's respiratory rate, heart rate and oxygen saturation will be observed.

Procedure: Venous catheter application

Virtual Reality Glasses

EXPERIMENTAL

A dinosaur movie suitable for the 7-12 age group will be watched 2-3 minutes before the venous catheter insertion. In this process, after cleaning the skin with the appropriate solution, a venous catheter will be inserted. During the procedure, the child's respiratory rate, heart rate and oxygen saturation will be observed.

Procedure: Venous catheter application

No intervention

NO INTERVENTION

The routine venous catheter placement protocol in the institution where the study is conducted will be applied. An evidence-based non-pharmacological method is not used to reduce pain during venous catheter insertion in children in the institution. A venous catheter is inserted by attaching a tourniquet to the child. During the procedure, the child's respiratory rate, heart rate and oxygen saturation will be observed.

Interventions

To examine the effect of virtual reality glasses and buzzy application on pain management during venous catheter insertion in children.

Buzzy applicationVirtual Reality Glasses

Eligibility Criteria

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

You may qualify if:

  • Those who volunteered to participate in the research
  • age group
  • The child does not have vision, hearing, mental or neurological sequelae.

You may not qualify if:

  • Children with a history of using sedative, analgesic or narcotic substances with analgesic effect before admission to the outpatient clinic will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suleyman Demirel University

Isparta, 32000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

AgnosiaPain

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Şerife Tutar T Assistant professor, PhD

    Suleyman Demirel University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Şerife Tutar T Assistant professor, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 21, 2022

First Posted

April 8, 2022

Study Start

February 1, 2022

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

April 8, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations