Anxiety and FearNCT06189222
The Effect of Virtual Reality Glasses Used During Intravenous Catheter Insertion
A study testing virtual reality glasses in people with Anxiety and Fear, run by Türkan Şen at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this clinical trial is to evaluate the effect of the virtual reality glasses device on the child's emotional responses during invasive interventions in child health services. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety and Fear
- What is being tested?
- virtual reality glasses
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2021to 30 Sep 2021
- 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
- Children who
- were aged 7-12,
- had parental permission,
- gave verbal consent,
- and whose parents could speak Turkish,
- were conscious,
- and did not have orthopedic, neurological, or sight-related problems that prevented wearing virtual reality glasses were included in the study.
Who cannot join
- Children who
- had a chronic disease that required frequent vascular access,
- had visual and hearing impairments,
- had a mental and neurological disability,
- had previously participated in a similar study,
- had a febrile illness at the time of application,
- had a history of fainting during vascular access procedures, or
- had used medication in the last 24 hours before the application, which might have an analgesic effect, were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality Glasses Used During Intravenous Catheter Insertion on The Child's Emotional Responses
The purpose of this clinical trial is to evaluate the effect of the virtual reality glasses device on the child's emotional responses during invasive interventions in child health services.
The main question it aims to answer are:
Read more
- Is there a difference between the emotional responses of children who watched cartoons with virtual reality glasses (experimental group) and the children in the control group during the intravenous catheter insertion process? First, the descriptive data form for the children was filled out for the control and study groups. Then, to distract the children during the application of the intravenous catheter, they watched cartoon videos of their choice for the 7-12 age group through virtual reality glasses by using a free internet application throughout the procedure. The procedure started with tying the tourniquet and continued until the intravenous catheter insertion was completed. During this period, the child's emotional responses were evaluated with the Children's Emotional Manifestation Scale. No intervention was applied to the control group. throughout the process the child's emotional responses were evaluated with the Children's Emotional Manifestation Scale.
No intervention was applied to the control group.
Read the detailed description
This study was conducted to determine the effect of virtual reality glasses used during intravenous catheter insertion on the child's emotional responses. The sample of the research, which was carried out as a randomized controlled experimental study, consisted of 102 children, including 51 in the control group and 51 in the study group, who were aged between 7 and 12 and were on treatment in the emergency department. Research data were collected using a Descriptive Data Form for Children and the Children's Emotional Manifestation Scale. During the data collection phase, first, the Descriptive Data Form for Children was filled out for the control and study groups. No intervention was applied to the control group. After the tourniquet was tied in the study group, the children started watching a video of their choice through virtual reality glasses. When the process was completed, the video was stopped. During this period, the child was evaluated using the Children's Emotional Manifestation Scale. A statistically significant difference was found between the Children's Emotional Manifestation Scale scores of the children in the study and control groups. The scores of the children in the study group were statistically significantly lower than the scores of the children in the control group.During the intravenous catheter insertion process, children who watched cartoons on virtual reality glasses showed less negative emotional behavior than those who did not.The use of virtual reality glasses is a developing technology in child health services, and it is recommended to encourage their use in these services.
- Conditions
- Anxiety and Fear
- Being tested
- virtual reality glasses
- Keywords
- Invasive procedures, Pediatrics, Emotion, Fear, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality glassesDevice
The population of the study consisted of children who were aged between 7- 12 and were on treatment using an intravenous catheter in the pediatric emergency unit of a state hospital in Turkey.Participants were divided into two groups, namely experimental and control groups, by using simple randomization software. The design and implementation of the study were based on the principles in the CONSORT list (Consolidated Standards of Reporting Studies). Descriptive data form for children,this form was prepared to collect information about the children included in the sample. It consists of seven questions on children's sociodemographic characteristics and previous intravenous catheter insertion experience.The Children's Emotional Manifestation Scale (CEMS), this scale was developed by Li \& Lopez (2005) to measure children's emotional responses during stressful medical procedures. The VR glasses we used in our study were connected to a mobile phone.
| Study group | Role | What they receive |
|---|---|---|
| virtual reality glasses | Experimental | The sample of the research, which was carried out as a randomized controlled experimental study, consisted of 102 children, including 51 in the control group and 51 in the study group, who were aged between 7 and 12 and were on treatment in the emergency department. Research data were collected using a Descriptive Data Form for Children and the Children's Emotional Manifestation Scale. During the data collection phase, first, the Descriptive Data Form for Children was filled out for the control and study groups. No intervention was applied to the control group. After the tourniquet was tied in the study group, the children started watching a video of their choice through virtual reality glasses. When the process was completed, the video was stopped. During this period, the child was evaluated using the Children's Emotional Manifestation Scale. Receives: Device: virtual reality glasses |
| standard care | No intervention | Intervention during intravenous catheter insertion to the child |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Children's Emotional Manifestation Scale (CEMS)
The scale, which allows direct behavioral observation, consists of five different behavioral categories, namely facial expression, vocalization, activity, interaction, and level of cooperation. Each category includes five different observable behaviors rated by level and intensity. The scale is scored by reviewing descriptions of the behavior in each category and selecting the value that most represents the observed behavior. Each category is scored from 1 to 5. The scores obtained for each category are summed and a total score between 5- 25 is obtained. High scale scores indicate the exhibition of more negative emotional behaviors.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start15 Mar 2021
- Primary completion15 Apr 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety and FearStudies 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
- Model description
- study group: children evaluated with virtual reality glasses control group: children receiving standard care
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Türkan Şen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Türkan Şen, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189222
- Sponsor's protocol ID
- PamukkaleU-SBF-TŞ-01
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasses Used During Intravenous Catheter Insertion on The Child's Emotional Responses
- ClinicalTrials.gov ID
- NCT06189222
- Acronym / sponsor ID
- PamukkaleU-SBF-TŞ-01
- Conditions
- Anxiety and Fear
- Keywords
- Invasive procedures, Pediatrics, Emotion, Fear, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Türkan ŞenUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 3 Jan 2024 (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 clinical trial is to evaluate the effect of the virtual reality glasses device on the child's emotional responses during invasive interventions in child health services.
The main question it aims to answer are:
- Is there a difference between the emotional responses of children who watched cartoons with virtual reality glasses (experimental group) and the children in the control group during the intravenous catheter insertion process? First, the descriptive data form for the children was filled out for the control and study groups. Then, to distract the children during the application of the intravenous catheter, they watched cartoon videos of their choice for the 7-12 age group through virtual reality glasses by using a free internet application throughout the procedure. The procedure started with tying the tourniquet and continued until the intravenous catheter insertion was completed. During this period, the child's emotional responses were evaluated with the Children's Emotional Manifestation Scale. No intervention was applied to the control group. throughout the process the child's emotional responses were evaluated with the Children's Emotional Manifestation Scale.
No intervention was applied to the control group.
Detailed description
This study was conducted to determine the effect of virtual reality glasses used during intravenous catheter insertion on the child's emotional responses. The sample of the research, which was carried out as a randomized controlled experimental study, consisted of 102 children, including 51 in the control group and 51 in the study group, who were aged between 7 and 12 and were on treatment in the emergency department. Research data were collected using a Descriptive Data Form for Children and the Children's Emotional Manifestation Scale. During the data collection phase, first, the Descriptive Data Form for Children was filled out for the control and study groups. No intervention was applied to the control group. After the tourniquet was tied in the study group, the children started watching a video of their choice through virtual reality glasses. When the process was completed, the video was stopped. During this period, the child was evaluated using the Children's Emotional Manifestation Scale. A statistically significant difference was found between the Children's Emotional Manifestation Scale scores of the children in the study and control groups. The scores of the children in the study group were statistically significantly lower than the scores of the children in the control group.During the intravenous catheter insertion process, children who watched cartoons on virtual reality glasses showed less negative emotional behavior than those who did not.The use of virtual reality glasses is a developing technology in child health services, and it is recommended to encourage their use in these services.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- study group: children evaluated with virtual reality glasses control group: children receiving standard care
| Arm | Type | Receives |
|---|---|---|
| virtual reality glasses | Experimental | Device: virtual reality glassesThe sample of the research, which was carried out as a randomized controlled experimental study, consisted of 102 children, including 51 in the control group and 51 in the study group, who were aged between 7 and 12 and were on treatment in the emergency department. Research data were collected using a Descriptive Data Form for Children and the Children's Emotional Manifestation Scale. During the data collection phase, first, the Descriptive Data Form for Children was filled out for the control and study groups. No intervention was applied to the control group. After the tourniquet was tied in the study group, the children started watching a video of their choice through virtual reality glasses. When the process was completed, the video was stopped. During this period, the child was evaluated using the Children's Emotional Manifestation Scale. |
| standard care | No intervention | –Intervention during intravenous catheter insertion to the child |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children who
Key exclusion criteria (8 listed)
- Children who
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 |
|---|---|---|
| virtual reality glassesThe population of the study consisted of children who were aged between 7- 12 and were on treatment using an intravenous catheter in the pediatric emergency unit of a state hospital in Turkey.Participants were divided into two groups, namely experimental and control groups, by using simple randomization software. The design and implementation of the study were based on the principles in the CONSORT list (Consolidated Standards of Reporting Studies). Descriptive data form for children,this form was prepared to collect information about the children included in the sample. It consists of seven questions on children's sociodemographic characteristics and previous intravenous catheter insertion experience.The Children's Emotional Manifestation Scale (CEMS), this scale was developed by Li \& Lopez (2005) to measure children's emotional responses during stressful medical procedures. The VR glasses we used in our study were connected to a mobile phone. | Device | virtual reality glasses |
Primary outcome
The Children's Emotional Manifestation Scale (CEMS)
Time frame: 7 months
The scale, which allows direct behavioral observation, consists of five different behavioral categories, namely facial expression, vocalization, activity, interaction, and level of cooperation. Each category includes five different observable behaviors rated by level and intensity. The scale is scored by reviewing descriptions of the behavior in each category and selecting the value that most represents the observed behavior. Each category is scored from 1 to 5. The scores obtained for each category are summed and a total score between 5- 25 is obtained. High scale scores indicate the exhibition of more negative emotional behaviors.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality glasses in people with Anxiety and Fear, run by Türkan Şen 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 3 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Children's Emotional Manifestation Scale (CEMS) (time frame: 7 months). 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 3 Jan 2024.