Acute PainNCT03913897
The Effect of Virtual Reality and Kaleidoscope on Pain and Anxiety Levels During Venipuncture in Children
A study testing distraction methods in people with Acute Pain, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Aim: The study was carried out in randomized control to determine the effect of two different distractions on pain and anxiety during blood collection. Methods: The population of the study consisted of children between ages of 4-10 years who applied for venipuncture to a training and research hospital in Turkey… Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pain
- What is being tested?
- distraction methods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jun 2018to 27 Nov 2018
- 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 4 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- being aged between 4 and 10 years for the child,
- applying for health control purpose,
- not having any chronic, mental or neurological illness,
- not using any analgesic in the last 6 hours before the venipuncture procedure.
Who cannot join
- -having a chronic, mental or neurological illness,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adiyaman University
Aim: The study was carried out in randomized control to determine the effect of two different distractions on pain and anxiety during blood collection.
Methods: The population of the study consisted of children between ages of 4-10 years who applied for venipuncture to a training and research hospital in Turkey between July and December 2018. A total of 139 children were included in the study, 46 of them with virtual reality goggles and 43 of them with control group. Information Form, Child Anxiety Scale, Visual Analogue Scale and Wong Baker Pain Scale were used in the collection of data.
- Conditions
- Acute Pain
- Being tested
- distraction methods
- Keywords
- acute pain, blood collection, nursing, children, distraction
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
distraction methodsOther
The children in the groups were distracted by virtual reality goggles and kaleidoscope 2 minutes before venipuncture, until the process was over
| Study group | Role | What they receive |
|---|---|---|
| virtual reality group | Experimental | The children in the groups were distracted by virtual reality goggles 2 minutes before venipuncture, until the process was over. Receives: Other: distraction methods |
| kaleidoscope group | Experimental | The children in the groups were distracted by kaleidoscope 2 minutes before the blood collection, until the process was over. Receives: Other: distraction methods |
| control group | No intervention | No intervention was made to children in the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children Fear Scale
The Children Fear Scale was used to evaluate the children's fear and anxiety. Children Fear Scale is a 0-4 scale, showing five faces that range from a neutral expression (0 = no anxiety) to a frightened face (4 = severe anxiety). Preprocedural and procedural pain, and anxiety were evaluated
Measured: 1 minute
Secondary outcomes (2)
Visual Analogue Scale
The visual analogue scale has been used for evaluating pain levels. Children were asked to mark the level of their pain on a l00 mm., Visual Analogue scale marked at one end as "no pain" and at the other as "worst pain imaginable.
Measured: 1 minute
Wong Baker Face Pain Scale
The Wong Baker Faces scale is a 0-10 scale. Six faces on the cards show a range of emotions from a smiling face (0 very happy/no pain) to a crying face (10 'hurts worst').
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start26 Jun 2018
- Primary completion27 Nov 2018
- Study completion27 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuba Koc Ozkan, Adiyaman University Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913897
- Sponsor's protocol ID
- 2018/5-18
- Status last verified
- Apr 2019
- First submitted
- 10 Apr 2019
- Last updated
- 16 Apr 2019
- Results posted
- 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 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adiyaman University
- ClinicalTrials.gov ID
- NCT03913897
- Acronym / sponsor ID
- 2018/5-18
- Conditions
- Acute Pain
- Keywords
- acute pain, blood collection, nursing, children, distraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 27 Nov 2018 (actual)
- Study completion
- 27 Nov 2018 (actual)
- First posted
- 12 Apr 2019 (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.
Aim: The study was carried out in randomized control to determine the effect of two different distractions on pain and anxiety during blood collection.
Methods: The population of the study consisted of children between ages of 4-10 years who applied for venipuncture to a training and research hospital in Turkey between July and December 2018. A total of 139 children were included in the study, 46 of them with virtual reality goggles and 43 of them with control group. Information Form, Child Anxiety Scale, Visual Analogue Scale and Wong Baker Pain Scale were used in the collection of data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| virtual reality group | Experimental | Other: distraction methodsThe children in the groups were distracted by virtual reality goggles 2 minutes before venipuncture, until the process was over. |
| kaleidoscope group | Experimental | Other: distraction methodsThe children in the groups were distracted by kaleidoscope 2 minutes before the blood collection, until the process was over. |
| control group | No intervention | –No intervention was made to children in the control group |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- being aged between 4 and 10 years for the child,
- applying for health control purpose,
- not having any chronic, mental or neurological illness,
- not using any analgesic in the last 6 hours before the venipuncture procedure.
Key exclusion criteria (1 listed)
- -having a chronic, mental or neurological illness,
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 |
|---|---|---|
| distraction methodsThe children in the groups were distracted by virtual reality goggles and kaleidoscope 2 minutes before venipuncture, until the process was over | Other | kaleidoscope group, virtual reality group |
Primary outcome
Children Fear Scale
Time frame: 1 minute
The Children Fear Scale was used to evaluate the children's fear and anxiety. Children Fear Scale is a 0-4 scale, showing five faces that range from a neutral expression (0 = no anxiety) to a frightened face (4 = severe anxiety). Preprocedural and procedural pain, and anxiety were evaluated
2 secondary outcomes
Visual Analogue Scale
Time frame: 1 minute
Wong Baker Face Pain Scale
Time frame: 1 minute
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 16 Apr 2019.
- 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.
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 distraction methods in people with Acute Pain, run by Adiyaman University Research Hospital 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 4 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: finished, as of the sponsor's last update on 16 Apr 2019. 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?
Children Fear Scale (time frame: 1 minute). 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 16 Apr 2019.