Clinical trial NCT05179291: Efficacy of VR and Buzzy on Pain and Anxiety
Official title: The Effects of Virtual Reality Glasses and External Cold and Vibration on Procedural Pain and Anxiety in Children During Venous Phlebotomy: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Procedural Pain
Procedural Anxiety
Pain
Children, Only
Keywords: Child
Child nursing
Non-pharmacological method
Pain relief
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 120
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study was designed as a randomized controlled experimental research with the purpose of determining the effect of distraction by using external cold and vibration-Buzzy and VR on reducing procedural pain and anxiety in children aged 7 to 12 years during phlebotomy injection.

Detailed description: In 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 Buzzy and VR on reducing procedural pain and anxiety in children aged 7 to 12 years during phlebotomy.

This study is a prospective, randomized and controlled trial. Children aged 7 to 12 years who required phlebotomy were divided into three groups; buzzy, virtual reality, and controls. 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 12 years who presented to the children's phlebotomy room of the hospital.

Sample of the study consisted of a total of 120 children who met the sample selection criteria and were selected via randomization method.

Children were randomized into three groups: Buzzy (n= 40), VR group (n= 40), and the control group (n= 40).

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

Eligibility criteria: Inclusion Criterial:

The sample selection criteria of the study were as follows: the children who

* were in the age group of 7-12 years,
* Due to undergo phlebotomy for blood testing,

Exclusion Criteria:

* had chronic diseases,
* had neuro-developmentally delayed,
* had visual, audio, or speech impairments,
* were hospital stay for treatment,
* had a history of sedative, analgesic or narcotic use within 24 hours before admission

Primary outcomes:
measure: Wong-Baker FACES Pain Rating Scale
timeFrame: Through painful procedure completion, an average of 10 minutes
measure: Children's Fear Scale
timeFrame: Through painful procedure completion, an average of 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Balikesir
country: Turkey
facility: Bandirma Onyedi Eylul University
state: Bandirma
Study officials:
References: