Effects of Virtual Reality Glasses, Kaleidoscope and Distraction Cards on Pain and Anxiety During Blood Draw in Children

NCT ID: NCT06192498

Last Updated: 2024-01-09

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study was designed as a randomized controlled experimental research with the purpose of determining the effect of distraction by using Virtual Reality Glasses, Kaleidoscope and Distraction Cards in reducing pain and anxiety during blood draw in children.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

n the literature, it is stated that nurses should use pharmacological and non-pharmacological methods in pain and anxiety management in painful procedures. Evidence-based studies are needed to show the effectiveness of non-pharmacological methods in reducing pain during invasive procedures and to investigate the effects of easy-to-apply methods on pain. In light of this information, this study aimed to compare the effect of distraction by using Virtual Reality Glasses, Kaleidoscope and Distraction Cards in reducing pain and anxiety during blood draw in children.

This study is a prospective, randomized and controlled trial. Children aged 7 to 11 years who required blood draw were divided into three groups; Virtual Reality Glasses, Kaleidoscope, Distraction Cards and Control. Data were obtained through face-to-face interviews with the children, their parents, and the observer before and after the procedure. The children's pain levels were assessed and reported by the parents and observers and the children themselves who self-reported using Wong-Baker FACES. The children's anxiety levels were also assessed using the Children's Fear Scale.

The study population consisted of children aged 7 to 11 years who presented to the children's blood draw room of the hospital.

Sample of the study consisted of a total of 400 children who met the sample selection criteria and were selected via randomization method.

Children were randomized into three groups: Virtual Reality Glasses group (n= 100), Kaleidoscope group (n= 100), Distraction Cards group (n= 100) and Control group (n= 100).

Data were collected using the Interview and Observation Form, Wong-Baker FACES Pain Rating Scale, Children's Fear Scale.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety Distraction Cards Nursing Caries Children, Only Fear Acute Pain Virtual Reality Kaleidoscope

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Virtual Reality Glasses Group

Virtual Reality(VR) Glasses were introduced to the children pre-procedure. The children were made to watch a video with VR glasses before starting the application and it continued until the end of the Blood Draw procedure.

Group Type EXPERIMENTAL

Virtual Reality Glasses

Intervention Type OTHER

Virtual Reality(VR) Glasses were introduced to the children pre-procedure. The children were made to watch a video with VR glasses before starting the application and it continued until the end of the Blood Draw procedure.

Kaleidoscope Group

Kaleidoscope were introduced to the children pre-procedure. The children were made to watch Kaleidoscope before starting the application and it continued until the end of the Blood Draw procedure.

Group Type EXPERIMENTAL

Kaleidoscope

Intervention Type OTHER

Kaleidoscope were introduced to the children pre-procedure. The children were made to watch Kaleidoscope before starting the application and it continued until the end of the Blood Draw procedure.

Distraction Cards Group

Distraction Cards were introduced to the children pre-procedure. The children were made to apply Distraction Cards before starting the application and it continued until the end of the Blood Draw procedure.

Group Type EXPERIMENTAL

Distraction Cards

Intervention Type OTHER

Distraction Cards were introduced to the children pre-procedure. The children were made to apply Distraction Cards before starting the application and it continued until the end of the Blood Draw procedure.

Control Group

In this group, children received routine blood draw procedure.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Virtual Reality Glasses

Virtual Reality(VR) Glasses were introduced to the children pre-procedure. The children were made to watch a video with VR glasses before starting the application and it continued until the end of the Blood Draw procedure.

Intervention Type OTHER

Kaleidoscope

Kaleidoscope were introduced to the children pre-procedure. The children were made to watch Kaleidoscope before starting the application and it continued until the end of the Blood Draw procedure.

Intervention Type OTHER

Distraction Cards

Distraction Cards were introduced to the children pre-procedure. The children were made to apply Distraction Cards before starting the application and it continued until the end of the Blood Draw procedure.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Children between the ages of 7-11,
* Volunteering of the child and parent to participate in the study,
* Blood draw for routine control purposes,
* Blood draw should be done by the same nurse,
* The needle on which blood draw will be performed must be of the same thickness.

Exclusion Criteria

* The child has any acute or chronic disease,
* The child has a mental disability, vision, speech or communication problems,
* The parent has hearing, vision or verbal communication difficulties,
* The child used analgesics in the last 6 hours,
* Infection, disruption of skin integrity and rash in the area where the application will be made,
Minimum Eligible Age

7 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Burdur Mehmet Akif Ersoy University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Selda Ateş Beşirik

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Selda Ateş Beşirik, PhD.

Role: PRINCIPAL_INVESTIGATOR

Burdur Mehmet Akif Ersoy University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Karaman Education and Research Hospital

Karaman, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Ates Besirik S, Canbulat Sahiner N. Comparison of the effectiveness of three different distraction methods in reducing pain and anxiety during blood drawing in children: A randomized controlled study. J Pediatr Nurs. 2024 Nov-Dec;79:225-233. doi: 10.1016/j.pedn.2024.09.009. Epub 2024 Sep 19.

Reference Type DERIVED
PMID: 39303378 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

07-2018/22

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Virtual Reality Distraction in Pediatric Patients.
NCT06355492 NOT_YET_RECRUITING PHASE4