Pain ManagementNCT05319210
The Effect of Virtual Reality and Buzzy Application on Pain Management in Children
A study testing Venous catheter application in people with Pain Management, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Management
- What is being tested?
- Venous catheter application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Those who volunteered to participate in the research
- 7-12 age group
- The child does not have vision, hearing, mental or neurological sequelae.
Who cannot join
- -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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Suleyman Demirel University
Isparta, 32000
Şerife Tutar, +0905053126429, serifeguven@sdu.edu.tr
Tuğçe Karol, +905079346721, tugcekarol32@gmail.com
About this study
Official title: Investigation of the Effect of Virtual Reality Glasses and Buzzy Application on Pain Management During Venous Catheter Insertion in Children
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.
Read the detailed description
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.
The universe of the research is all children between the ages of 7 and 12 who applied to Hospital Emergency Service will be formed. G power analysis program was used to calculate the sample size of the study. The number of samples was calculated according to 95% power, 0.05 margin of error and 0.80 effect size. It is envisaged that 36 children will be included in the sample for each group. However, considering that sample losses may be experienced during the process of the research, it is planned to include 40 participants (120 participants in total) for each group.
"Child and Parent Diagnosis Form", "Child Fear Scale (CDS)", "Child Anxiety Scale-State (CAS-D)" and Wong-Baker Faces Pain Scale will be used to collect research data.
In the collection of research data, first of all, patients will be divided into intervention and control groups in accordance with the randomization scheme. Our research will consist of two interventions (Buzzy device, virtual reality glasses) and a control group (routine outpatient procedures).
Before the procedure; Written and verbal "Informed Consent" will be obtained from all participants in the intervention and control groups. "Child and Parent Diagnosis Form", "Child Fear Scale (CDS)", "Child Anxiety Scale-State (CAS-D)" and Wong-Baker Faces Pain Scale will be applied to the participants who agree to participate in the study.
Process Sequence and After; Venous catheter insertion will be done in line with the routine practice of the outpatient clinic. Venous catheter placement in all children included in the study will be performed by the researcher working in this one in order to keep the practitioner-related factors under control. Children who cannot insert a venous catheter in a single attempt will be excluded from the study.
Licensed SPSS (Statistical Package for the Social Science) 20.0 package program will be used in the evaluation of the data. Descriptive analyzes such as number, percentage, frequency, mean, standard deviation and percentile distributions will be used to evaluate the characteristics of children. Nonparametric tests will be used according to the results of normal distribution and homogeneity of variance. Mann Whitney U test, Wilcoxon test and correlation analyzes will be used to evaluate the relationships between dependent and independent variables. Results will be evaluated at 95% confidence interval and p<0.05 significance level.
- Conditions
- Pain Management
- Being tested
- Venous catheter application
- Keywords
- pain, virtual reality glasses, buzzy application, children, venous catheter
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous catheter applicationProcedure or surgery
To examine the effect of virtual reality glasses and buzzy application on pain management during venous catheter insertion in children.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 month
Secondary outcomes (2)
Management of fear in children
Management of fear during venous catheter insertion in children. The parameter for fear management will be determined by the Child Fear Scale.
Measured: 4 month
Management of anxiety in children
It is the management of anxiety during venous catheter placement in children. The parameter for Anxiety management will be determined by Child Anxiety Scale.
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start1 Feb 2022
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serife Tutar, Suleyman Demirel University
- Investigators
- Şerife Tutar T Assistant professor, PhD, Principal investigator, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319210
- Sponsor's protocol ID
- 188972
- Status last verified
- Mar 2022
- First submitted
- 21 Mar 2022
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Virtual Reality Glasses and Buzzy Application on Pain Management During Venous Catheter Insertion in Children
- ClinicalTrials.gov ID
- NCT05319210
- Acronym / sponsor ID
- 188972
- Conditions
- Pain Management
- Keywords
- pain, virtual reality glasses, buzzy application, children, venous catheter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The universe of the research is all children between the ages of 7 and 12 who applied to Hospital Emergency Service will be formed. G power analysis program was used to calculate the sample size of the study. The number of samples was calculated according to 95% power, 0.05 margin of error and 0.80 effect size. It is envisaged that 36 children will be included in the sample for each group. However, considering that sample losses may be experienced during the process of the research, it is planned to include 40 participants (120 participants in total) for each group.
"Child and Parent Diagnosis Form", "Child Fear Scale (CDS)", "Child Anxiety Scale-State (CAS-D)" and Wong-Baker Faces Pain Scale will be used to collect research data.
In the collection of research data, first of all, patients will be divided into intervention and control groups in accordance with the randomization scheme. Our research will consist of two interventions (Buzzy device, virtual reality glasses) and a control group (routine outpatient procedures).
Before the procedure; Written and verbal "Informed Consent" will be obtained from all participants in the intervention and control groups. "Child and Parent Diagnosis Form", "Child Fear Scale (CDS)", "Child Anxiety Scale-State (CAS-D)" and Wong-Baker Faces Pain Scale will be applied to the participants who agree to participate in the study.
Process Sequence and After; Venous catheter insertion will be done in line with the routine practice of the outpatient clinic. Venous catheter placement in all children included in the study will be performed by the researcher working in this one in order to keep the practitioner-related factors under control. Children who cannot insert a venous catheter in a single attempt will be excluded from the study.
Licensed SPSS (Statistical Package for the Social Science) 20.0 package program will be used in the evaluation of the data. Descriptive analyzes such as number, percentage, frequency, mean, standard deviation and percentile distributions will be used to evaluate the characteristics of children. Nonparametric tests will be used according to the results of normal distribution and homogeneity of variance. Mann Whitney U test, Wilcoxon test and correlation analyzes will be used to evaluate the relationships between dependent and independent variables. Results will be evaluated at 95% confidence interval and p<0.05 significance level.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Buzzy application | Experimental | Procedure: Venous catheter applicationIt 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. |
| Virtual Reality Glasses | Experimental | Procedure: Venous catheter applicationA 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. |
| 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. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Those who volunteered to participate in the research
- 7-12 age group
- The child does not have vision, hearing, mental or neurological sequelae.
Key exclusion criteria (1 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venous catheter applicationTo examine the effect of virtual reality glasses and buzzy application on pain management during venous catheter insertion in children. | Procedure or surgery | Buzzy application, Virtual Reality Glasses |
Primary outcome
Pain management
Time frame: 4 month
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.
2 secondary outcomes
Management of fear in children
Time frame: 4 month
Management of anxiety in children
Time frame: 4 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şerife Tutar T Assistant professor, PhD principal investigator
Suleyman Demirel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venous catheter application in people with Pain Management, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Şerife Tutar T Assistant professor, PhD (+905053126429, serifeguven@sdu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain management (time frame: 4 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.