Pain, AcuteNCT06011668
EFFECT OF DISTRACTION METHODS ON PAIN AND ANXIETY DURING INTRAMUSCULAR INJECTION IN CHILDREN
A study testing video game playing, kaleidoscope and virtual reality glasses in people with Pain, Acute and Anxiety and Fear, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
This thesis study was conducted in an unblinded, randomized controlled experimental manner in order to analyze the effect of attention-drawing methods that can be used during intramuscular injection in children on pain and anxiety. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Anxiety and Fear
- What is being tested?
- video game playing, kaleidoscope and 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
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2021to 15 Dec 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between the ages of 6-12 and their families who speak Turkish and accepted the voluntary informed consent form verbally and in writing.
- Children who do not have a chronic disease (Children with chronic diseases such as DM, asthma, hypertension, meningitis, epilepsy, etc. will not be included in the study as their response levels to pain will vary.)
- Children who have not taken an analgesic drug in the last 6 hours
- No physical or mental illness
- Children who have no suspicion of covid 19 transmission in their family or themselves
- Children whose vital signs are in parameters suitable for their age will be taken.
Who cannot join
- Children who did not accept the voluntary informed consent form verbally and in writing
- Children with chronic diseases (Children with chronic diseases such as DM, asthma, hypertension, meningitis, epilepsy, etc. will not be included in the study as their response levels to pain will vary.)
- Children who have taken an analgesic drug in the past 6 hours
- Those who have a suspected covid 19 transmission in their family or themselves
- Children with any physical or mental illness will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE EFFECT OF DISTRACTION METHODS ON PAIN AND ANXIETY DURING INTRAMUSCULAR INJECTION IN CHILDREN AGED 6-12 YEARS
This thesis study was conducted in an unblinded, randomized controlled experimental manner in order to analyze the effect of attention-drawing methods that can be used during intramuscular injection in children on pain and anxiety.
Read the detailed description
Data were collected in the Pediatric Emergency Injection Unit of Mersin City Training and Research Hospital between October and December 2021. Children aged 6-12 years were included in the study. In the study, the sample was divided into four groups. The study consisted of 180 children, 45 children in each group. Using the randomization program, it was determined which sample group the children would be included in.
In the study, video game playing, kaleidoscope and virtual reality glasses were used as a distraction method for the experimental group. Intramuscular injection (IM) was applied to the control group without any application. The research implementation period lasted an average of one minute. Required ethical permissions were obtained prior to the research. Wong-Baker Faces Pain Scale (WBFPRS) was used to measure pain level and Child Fear Scale (CFS) was used to measure anxiety level in the study. Explanatory information about the application to be made to the children and their parents was given by the researcher, and the consent form was signed by informing them voluntarily. The research data were collected by the researcher by interviewing the children face to face. In line with the data obtained in the study, it was concluded that the descriptive characteristics of the children in the experimental and control groups were similar (p>0.05). It was concluded that playing video games, kaleidoscope, and virtual reality glasses, among the distraction methods applied in the study, reduced pain and anxiety. It is expected that techniques that reduce pain and anxiety when intramuscular injections are given to children in nursing practices will be used in practice and that these practices will be included in the training of nurses.
- Conditions
- Pain, Acute, Anxiety and Fear
- Being tested
- video game playing, kaleidoscope and virtual reality glasses
- Keywords
- Pain, Anxiety, Distraction, Children, Intramuscular injection
- Medical subject headings
- Acute Pain, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video game playing, kaleidoscope and virtual reality glassesDevice
This thesis study was conducted with randomized controlled methods for control in order to analyze the effect of drawing attention to different directions during intramuscular use in countries to what extent the methods of drawing attention to pain and anxiety.
| Study group | Role | What they receive |
|---|---|---|
| distraction method | Experimental | video game playing Receives: Device: video game playing, kaleidoscope and virtual reality glasses |
| distraction | Experimental | kaleidoscope Receives: Device: video game playing, kaleidoscope and virtual reality glasses |
| distraction methods | Experimental | virtual reality glasses Receives: Device: video game playing, kaleidoscope and virtual reality glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain was measured by Wong- Baker Faces Pain Scale
The scale, which was developed by Wong and Baker in 1981 and renewed in 1983, is one of the most common methods used in pain assessment. The use of the scale is suitable for 3 years old and above. Before using the scale, the pain level of the statements on the scale should be explained to the child.
Measured: at 1st minute before the procedure
Pain was measured by Wong- Baker Faces Pain Scale
The scale, which was developed by Wong and Baker in 1981 and renewed in 1983, is one of the most common methods used in pain assessment. The use of the scale is suitable for 3 years old and above. Before using the scale, the pain level of the statements on the scale should be explained to the child.
Measured: during the procedure
Pain was measured by Wong- Baker Faces Pain Scale
The scale, which was developed by Wong and Baker in 1981 and renewed in 1983, is one of the most common methods used in pain assessment. The use of the scale is suitable for 3 years old and above. Before using the scale, the pain level of the statements on the scale should be explained to the child.
Measured: at 1st minute after the procedure
Fear was measured by Child Fear Scale
In this scale, in which neutral anxiety expression is indicated as (0) and high level of anxiety/fear is indicated as (4), there are facial expressions that progress gradually from neutral anxiety expression to high level of anxiety.
Measured: at 1st minute before the procedure
Fear was measured by Child Fear Scale
In this scale, in which neutral anxiety expression is indicated as (0) and high level of anxiety/fear is indicated as (4), there are facial expressions that progress gradually from neutral anxiety expression to high level of anxiety.
Measured: during the procedure
Fear was measured by Child Fear Scale
In this scale, in which neutral anxiety expression is indicated as (0) and high level of anxiety/fear is indicated as (4), there are facial expressions that progress gradually from neutral anxiety expression to high level of anxiety.
Measured: at 1st minute after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start15 Oct 2021
- Primary completion15 Oct 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Senem Merve KURT, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011668
- Sponsor's protocol ID
- SKURT-001
- Status last verified
- Aug 2023
- First submitted
- 12 Aug 2023
- Last updated
- 25 Aug 2023
- 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 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF DISTRACTION METHODS ON PAIN AND ANXIETY DURING INTRAMUSCULAR INJECTION IN CHILDREN AGED 6-12 YEARS
- ClinicalTrials.gov ID
- NCT06011668
- Acronym / sponsor ID
- SKURT-001
- Conditions
- Pain, Acute, Anxiety and Fear
- Keywords
- Pain, Anxiety, Distraction, Children, Intramuscular injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 25 Aug 2023 (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.
This thesis study was conducted in an unblinded, randomized controlled experimental manner in order to analyze the effect of attention-drawing methods that can be used during intramuscular injection in children on pain and anxiety.
Detailed description
Data were collected in the Pediatric Emergency Injection Unit of Mersin City Training and Research Hospital between October and December 2021. Children aged 6-12 years were included in the study. In the study, the sample was divided into four groups. The study consisted of 180 children, 45 children in each group. Using the randomization program, it was determined which sample group the children would be included in.
In the study, video game playing, kaleidoscope and virtual reality glasses were used as a distraction method for the experimental group. Intramuscular injection (IM) was applied to the control group without any application. The research implementation period lasted an average of one minute. Required ethical permissions were obtained prior to the research. Wong-Baker Faces Pain Scale (WBFPRS) was used to measure pain level and Child Fear Scale (CFS) was used to measure anxiety level in the study. Explanatory information about the application to be made to the children and their parents was given by the researcher, and the consent form was signed by informing them voluntarily. The research data were collected by the researcher by interviewing the children face to face. In line with the data obtained in the study, it was concluded that the descriptive characteristics of the children in the experimental and control groups were similar (p>0.05). It was concluded that playing video games, kaleidoscope, and virtual reality glasses, among the distraction methods applied in the study, reduced pain and anxiety. It is expected that techniques that reduce pain and anxiety when intramuscular injections are given to children in nursing practices will be used in practice and that these practices will be included in the training of nurses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| distraction method | Experimental | Device: video game playing, kaleidoscope and virtual reality glassesvideo game playing |
| distraction | Experimental | Device: video game playing, kaleidoscope and virtual reality glasseskaleidoscope |
| distraction methods | Experimental | Device: video game playing, kaleidoscope and virtual reality glassesvirtual reality glasses |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children between the ages of 6-12 and their families who speak Turkish and accepted the voluntary informed consent form verbally and in writing.
- Children who do not have a chronic disease (Children with chronic diseases such as DM, asthma, hypertension, meningitis, epilepsy, etc. will not be included in the study as their response levels to pain will vary.)
- Children who have not taken an analgesic drug in the last 6 hours
- No physical or mental illness
- Children who have no suspicion of covid 19 transmission in their family or themselves
Key exclusion criteria (5 listed)
- Children who did not accept the voluntary informed consent form verbally and in writing
- Children with chronic diseases (Children with chronic diseases such as DM, asthma, hypertension, meningitis, epilepsy, etc. will not be included in the study as their response levels to pain will vary.)
- Children who have taken an analgesic drug in the past 6 hours
- Those who have a suspected covid 19 transmission in their family or themselves
- Children with any physical or mental illness will not be included.
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 |
|---|---|---|
| video game playing, kaleidoscope and virtual reality glassesThis thesis study was conducted with randomized controlled methods for control in order to analyze the effect of drawing attention to different directions during intramuscular use in countries to what extent the methods of drawing attention to pain and anxiety. | Device | distraction, distraction method, distraction methods |
Primary outcome
Pain was measured by Wong- Baker Faces Pain Scale
Time frame: at 1st minute before the procedure
The scale, which was developed by Wong and Baker in 1981 and renewed in 1983, is one of the most common methods used in pain assessment. The use of the scale is suitable for 3 years old and above. Before using the scale, the pain level of the statements on the scale should be explained to the child.
Pain was measured by Wong- Baker Faces Pain Scale
Time frame: during the procedure
The scale, which was developed by Wong and Baker in 1981 and renewed in 1983, is one of the most common methods used in pain assessment. The use of the scale is suitable for 3 years old and above. Before using the scale, the pain level of the statements on the scale should be explained to the child.
Pain was measured by Wong- Baker Faces Pain Scale
Time frame: at 1st minute after the procedure
The scale, which was developed by Wong and Baker in 1981 and renewed in 1983, is one of the most common methods used in pain assessment. The use of the scale is suitable for 3 years old and above. Before using the scale, the pain level of the statements on the scale should be explained to the child.
Fear was measured by Child Fear Scale
Time frame: at 1st minute before the procedure
In this scale, in which neutral anxiety expression is indicated as (0) and high level of anxiety/fear is indicated as (4), there are facial expressions that progress gradually from neutral anxiety expression to high level of anxiety.
Fear was measured by Child Fear Scale
Time frame: during the procedure
In this scale, in which neutral anxiety expression is indicated as (0) and high level of anxiety/fear is indicated as (4), there are facial expressions that progress gradually from neutral anxiety expression to high level of anxiety.
Fear was measured by Child Fear Scale
Time frame: at 1st minute after the procedure
In this scale, in which neutral anxiety expression is indicated as (0) and high level of anxiety/fear is indicated as (4), there are facial expressions that progress gradually from neutral anxiety expression to high level of anxiety.
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 25 Aug 2023.
- 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 video game playing, kaleidoscope and virtual reality glasses in people with Pain, Acute and Anxiety and Fear, run by Mersin 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 6 inclusion and 5 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 25 Aug 2023. 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?
Pain was measured by Wong- Baker Faces Pain Scale (time frame: at 1st minute before the procedure). The study lists 6 primary outcomes in all. 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 25 Aug 2023.