Efficacy of VR and Buzzy on Pain and Anxiety
Primary Purpose
Procedural Pain, Procedural Anxiety, Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Buzzy Group
Virtual Realitiy-VR Group
Sponsored by
About this trial
This is an interventional supportive care trial for Procedural Pain focused on measuring Child, Child nursing, Non-pharmacological method, Pain relief
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
Sites / Locations
- Bandirma Onyedi Eylul University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Buzzy Group
Virtual Realitiy-VR Group
Control Group
Arm Description
In this group external cold and vibration-Buzzy was applied to the children during phlebotomy.
In this group Virtual Realitiy-VR was applied to the children during phlebotomy.
In this group, children received routine phlebotomy procedure
Outcomes
Primary Outcome Measures
Wong-Baker FACES Pain Rating Scale
In the study, pain level evaluations, the children's self-evaluations, parents' evaluations and the researcher's evaluations were carried out using the WB-FACES scale. This scale was developed by Donna Wong and Connie Morain Baker in 1988. The scale is graded between 0-10 points. A smiling face on the far left symbolizes "no pain" (0 very happy/no pain) and the pain increases from left to right. On the other hand, a crying face on the far right symbolizes "unbearable pain" (10 'hurts worst'). As the numbers increase in this scoring system, facial expressions also change referring to an increase in pain levels.
Children's Fear Scale
CFS is used for measuring the child's anxiety level. CFS is a scale which makes an evaluation from 0 to 4 consisting of five facial expressions drawn to show expressions that vary from neutral expression (0=no anxiety) to scared face (4=severe anxiety).
Secondary Outcome Measures
Full Information
NCT ID
NCT05179291
First Posted
December 16, 2021
Last Updated
January 4, 2022
Sponsor
Bandırma Onyedi Eylül University
1. Study Identification
Unique Protocol Identification Number
NCT05179291
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
April 21, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bandırma Onyedi Eylül University
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Procedural Pain, Procedural Anxiety, Pain, Children, Only
Keywords
Child, Child nursing, Non-pharmacological method, Pain relief
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Buzzy Group
Arm Type
Experimental
Arm Description
In this group external cold and vibration-Buzzy was applied to the children during phlebotomy.
Arm Title
Virtual Realitiy-VR Group
Arm Type
Experimental
Arm Description
In this group Virtual Realitiy-VR was applied to the children during phlebotomy.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
In this group, children received routine phlebotomy procedure
Intervention Type
Other
Intervention Name(s)
Buzzy Group
Intervention Description
The Buzzy device was placed 5-10 cm above the injection area and making sure that it was in contact with the skin. The ice pack was kept in the deep freezer and placed into the device before the application. Buzzy was introduced to the children pre-procedure. Cold application and vibration were started pre-procedure and maintained until the procedure was completed. Following the Buzzy application, the device was wiped with 70% alcohol and used for other children. The Buzzy devices were kept in the deep freeze and refrozen. The same person conducted the pain reduction methods during phlebotomy.
Intervention Type
Other
Intervention Name(s)
Virtual Realitiy-VR Group
Intervention Description
VR glasses were introduced to the children pre-procedure. The children were made to watch a video with VR glasses 2-3 minutes before starting the application and it continued until the end of the phlebotomy procedure (three minutes on average). 3D video suggestions (Space Experience, Blue Whale 360 VR Experience) were offered to the children before the phlebotomy procedure and they were asked to choose one of them.
Primary Outcome Measure Information:
Title
Wong-Baker FACES Pain Rating Scale
Description
In the study, pain level evaluations, the children's self-evaluations, parents' evaluations and the researcher's evaluations were carried out using the WB-FACES scale. This scale was developed by Donna Wong and Connie Morain Baker in 1988. The scale is graded between 0-10 points. A smiling face on the far left symbolizes "no pain" (0 very happy/no pain) and the pain increases from left to right. On the other hand, a crying face on the far right symbolizes "unbearable pain" (10 'hurts worst'). As the numbers increase in this scoring system, facial expressions also change referring to an increase in pain levels.
Time Frame
Through painful procedure completion, an average of 10 minutes
Title
Children's Fear Scale
Description
CFS is used for measuring the child's anxiety level. CFS is a scale which makes an evaluation from 0 to 4 consisting of five facial expressions drawn to show expressions that vary from neutral expression (0=no anxiety) to scared face (4=severe anxiety).
Time Frame
Through painful procedure completion, an average of 10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Bandirma Onyedi Eylul University
City
Balikesir
State/Province
Bandirma
ZIP/Postal Code
10200
Country
Turkey
12. IPD Sharing Statement
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Efficacy of VR and Buzzy on Pain and Anxiety
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