Intramuscular InjectionNCT05833854
The Effect of Two Different Methods Applied During Intramuscular Injection on the Level of Pain and Fear in Children
A study testing Virtual reality glasses group and Manual pressure group in people with Intramuscular Injection, run by Selmin Kose at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to determine the effects of using virtual reality glasses and manual pressure during intramuscular injection on the level of pain and fear in children. The study will consist of children aged 6-10 years who come to the Pediatric Emergency Service injection room for prescription penicillin… Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Intramuscular Injection
- What is being tested?
- Virtual reality glasses group and Manual pressure group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Dec 2023to 29 Feb 2024
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Having applied to the pediatric emergency service for the administration of a penicillin antibiotic group drug,
- Absence of a significant chronic disease,
- Absence of visual and auditory disabilities,
- Having no communication problems and being conscious,
- No previous history of fainting during injection,
- Not taking analgesics in the last three hours,
Show all 9Show fewer
- Percentile value is in the range of 3-97 points,
- Injection into the vastus lateralis muscle can be applied,
- The child's and parent's willingness to participate in the research.
Who cannot join
- The percentile value is below 3 and the percentile value is above 97,
- Family's inability to cooperate in the assessment of pain and fear,
- Having a diagnosed physical or mental disability,
- To have taken analgesics in the last 3 hours,
- Presence of incision and scar tissue in the area to be injected,
- The child's and parent's refusal to participate in the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Use of Virtual Reality Glasses and Manual Pressure Method on the Level of Pain and Fear in Children During Intramuscular Injection
This study was planned to determine the effects of using virtual reality glasses and manual pressure during intramuscular injection on the level of pain and fear in children. The study will consist of children aged 6-10 years who come to the Pediatric Emergency Service injection room for prescription penicillin injection and meet the inclusion criteria. One of the main purposes of nursing care is to relieve the child's pain and improve the quality of life. In this context, it has been suggested that two different methods used by the researcher can positively affect the levels of pain and fear. For this reason, it is aimed to determine the efficiency level of two different methods.
Read the detailed description
75 children and parents meeting the inclusion criteria will be included in the study. For the penicillin injection prescribed by the doctor, the child and the parent who come to the pediatric emergency injection room of the hospital where the research is carried out are informed about the study and the parent is asked to sign the "Informed Consent Form". . After obtaining the consent of the family, the "Child-Parent Information Form" is filled by the researcher through the parent. Simple randomization will be done to give an equal number of samples to the control, virtual reality glasses and manual pressure group to be applied to the child who will participate in the study. Randomization of the study will be done with the online program at the URL https://www.randomizer.org/. Children to be included in the sample will be divided into three groups by randomization method. The numbers from 1 to 75 will be entered into the program without repeating, in order to determine which group the children included in the study will be in. The children who will form the study group through the program will be randomly distributed into 3 groups. . The two interventions in the study will be virtual reality glasses (n=25) and manual pressure (n=25) and control group (n=25).
In the control group (n=25), the child, the parent and the researcher will evaluate the children's fear levels before the procedure with the Child Fear Scale. In this group, a routine intramuscular injection will be made into the vastus lateralis muscle and the researcher will perform the application. No intervention other than routine will be applied. After the intramuscular injection, the pain level of the children will be evaluated by the child, the parent and the researcher with the Facial Expressions Pain Scale-Remodeled.
The group (n=25) wearing VR Glasses will be shown an age-appropriate VR video alongside the routine practice. Before the procedure, the level of fear will be evaluated as in the control group. A virtual reality VR video is watched 1 minute before the intramuscular injection. The child who continues to watch the video is placed on his back and penicillin is injected intramuscularly into the vastus lateralis muscle. Post-injection pain level will be evaluated as in the control group. Virtual reality glasses compatible with "VR BOX 3D" smartphones will be used in this group. Product weight: 0.414 kg. Product size (length x depth x height): 19.5 x 14 x 11 cm/ 7.66 x x5.50 x 4.32 inches. No power adapter or connection cable other than the phone will be needed during use. All children participating in the research will watch the "Hidden Underwater World", which is recommended by taking the opinion of an expert (child developmentist) suitable for their age. The virtual reality glasses used in the application will be disinfected and ready for the next application.
The manual pressure group (n=25) will be evaluated with the Child Fear Scale before the procedure. In addition to the routine application, pressure will be applied to the area to be injected for 10 seconds before the injection process. Pressing with the thumb of the hand, which will be passive in the pressing application, will be understood by the whitening of the nail, and thus pressure will be applied to the skin. Then, as in other groups, an injection will be made into the vastus lateralis area. After the injection, the child will be evaluated in terms of pain with the Facial Expressions Pain Scale revised by the parent and the researcher.
Informed Consent Form, Child-Parent Information Form, Child Fear Scale and Facial Expressions Pain Scale-Revised will be filled for each child who will participate in the study. It is planned to fill the Child Fear Scale before the injection and the Facial Expressions Pain Scale-Revised after the injection.
It is planned that the scales to be applied to the child and parent who will participate in the research will be applied face to face in the injection room of the hospital and 10-15 minutes will be given for each application.
The obtained data will be evaluated using the necessary statistical tests in the computer environment. Evaluation methods will be chosen based on whether the data is homogeneously distributed. If it has a homogeneous distribution, parametric tests will be used. If it does not have a homogeneous distribution, non-parametric methods will be used.
- Conditions
- Intramuscular Injection
- Being tested
- Virtual reality glasses group, Manual pressure group
- Keywords
- manual pressure, virtual reality glasses, intramuscular injection, pain, fear
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality glasses groupOther
It is suggested that the use of virtual reality glasses during the injection will positively affect the pain and fear levels in children who received penicillin injection in the pediatric emergency department where the study was conducted.
Manual pressure groupOther
In the pediatric emergency department where the study was conducted, pressure will be applied to the area to be injected for 10 seconds before the injection procedure in children who received penicillin injection. Pressing with the thumb of the hand, which will be passive in the pressing application, will be understood by the whitening of the nail, and thus pressure will be applied to the skin. It is suggested that it can positively affect pain and fear levels.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality glasses group | Experimental | The study group (n=25) will watch a video with virtual reality glasses during the intramuscular injection. Receives: Other: Virtual reality glasses group |
| Manual pressure group | Experimental | In the study group (n=25), pressure will be applied to the area to be injected for 10 seconds before the intramuscular injection procedure. Receives: Other: Manual pressure group |
| Control group | No intervention | The control group (n=25) will not be subjected to any application other than intramuscular injection, which is routinely applied in pediatric emergency. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Fear Scale
The purpose of the Child Fear Scale is to evaluate the fear level of children. It consisted of five facial expressions ranging from neutral expression (0 = No anxiety) to fearful expression (4 = Severe anxiety).
Measured: The child's fear level will be evaluated by 3 people (child, parent and researcher) 2 minutes before intramuscular penicillin injection is given to the whole group. This process will take 1 minute.
Secondary outcomes (1)
Facial Expressions Pain Scale-Revised
It is a valid and reliable scale that children can express themselves in their painful situations. It consists of 6 facial expressions that determine the severity and presence of pain by scoring between 0 and 10.
Measured: Two minutes after intramuscular penicillin injection is given to the whole group, the child's pain will be evaluated by 3 people (child, parent and researcher). This process takes 1 minute.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start11 Dec 2023
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intramuscular InjectionStudies 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selmin Kose
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Selmin Kose, Biruni University
- Investigators
- EMINE KURTAR, RN, Principal investigator, Adana City Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833854
- Sponsor's protocol ID
- 732202
- Status last verified
- Mar 2024
- First submitted
- 2 Apr 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to Hospital policy, the individual participant data can not be shared with anyone except researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Use of Virtual Reality Glasses and Manual Pressure Method on the Level of Pain and Fear in Children During Intramuscular Injection
- ClinicalTrials.gov ID
- NCT05833854
- Acronym / sponsor ID
- 732202
- Conditions
- Intramuscular Injection
- Keywords
- manual pressure, virtual reality glasses, intramuscular injection, pain, fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Selmin KoseUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 27 Apr 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 study was planned to determine the effects of using virtual reality glasses and manual pressure during intramuscular injection on the level of pain and fear in children. The study will consist of children aged 6-10 years who come to the Pediatric Emergency Service injection room for prescription penicillin injection and meet the inclusion criteria. One of the main purposes of nursing care is to relieve the child's pain and improve the quality of life. In this context, it has been suggested that two different methods used by the researcher can positively affect the levels of pain and fear. For this reason, it is aimed to determine the efficiency level of two different methods.
Detailed description
75 children and parents meeting the inclusion criteria will be included in the study. For the penicillin injection prescribed by the doctor, the child and the parent who come to the pediatric emergency injection room of the hospital where the research is carried out are informed about the study and the parent is asked to sign the "Informed Consent Form". . After obtaining the consent of the family, the "Child-Parent Information Form" is filled by the researcher through the parent. Simple randomization will be done to give an equal number of samples to the control, virtual reality glasses and manual pressure group to be applied to the child who will participate in the study. Randomization of the study will be done with the online program at the URL https://www.randomizer.org/. Children to be included in the sample will be divided into three groups by randomization method. The numbers from 1 to 75 will be entered into the program without repeating, in order to determine which group the children included in the study will be in. The children who will form the study group through the program will be randomly distributed into 3 groups. . The two interventions in the study will be virtual reality glasses (n=25) and manual pressure (n=25) and control group (n=25).
In the control group (n=25), the child, the parent and the researcher will evaluate the children's fear levels before the procedure with the Child Fear Scale. In this group, a routine intramuscular injection will be made into the vastus lateralis muscle and the researcher will perform the application. No intervention other than routine will be applied. After the intramuscular injection, the pain level of the children will be evaluated by the child, the parent and the researcher with the Facial Expressions Pain Scale-Remodeled.
The group (n=25) wearing VR Glasses will be shown an age-appropriate VR video alongside the routine practice. Before the procedure, the level of fear will be evaluated as in the control group. A virtual reality VR video is watched 1 minute before the intramuscular injection. The child who continues to watch the video is placed on his back and penicillin is injected intramuscularly into the vastus lateralis muscle. Post-injection pain level will be evaluated as in the control group. Virtual reality glasses compatible with "VR BOX 3D" smartphones will be used in this group. Product weight: 0.414 kg. Product size (length x depth x height): 19.5 x 14 x 11 cm/ 7.66 x x5.50 x 4.32 inches. No power adapter or connection cable other than the phone will be needed during use. All children participating in the research will watch the "Hidden Underwater World", which is recommended by taking the opinion of an expert (child developmentist) suitable for their age. The virtual reality glasses used in the application will be disinfected and ready for the next application.
The manual pressure group (n=25) will be evaluated with the Child Fear Scale before the procedure. In addition to the routine application, pressure will be applied to the area to be injected for 10 seconds before the injection process. Pressing with the thumb of the hand, which will be passive in the pressing application, will be understood by the whitening of the nail, and thus pressure will be applied to the skin. Then, as in other groups, an injection will be made into the vastus lateralis area. After the injection, the child will be evaluated in terms of pain with the Facial Expressions Pain Scale revised by the parent and the researcher.
Informed Consent Form, Child-Parent Information Form, Child Fear Scale and Facial Expressions Pain Scale-Revised will be filled for each child who will participate in the study. It is planned to fill the Child Fear Scale before the injection and the Facial Expressions Pain Scale-Revised after the injection.
It is planned that the scales to be applied to the child and parent who will participate in the research will be applied face to face in the injection room of the hospital and 10-15 minutes will be given for each application.
The obtained data will be evaluated using the necessary statistical tests in the computer environment. Evaluation methods will be chosen based on whether the data is homogeneously distributed. If it has a homogeneous distribution, parametric tests will be used. If it does not have a homogeneous distribution, non-parametric methods will be used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual reality glasses group | Experimental | Other: Virtual reality glasses groupThe study group (n=25) will watch a video with virtual reality glasses during the intramuscular injection. |
| Manual pressure group | Experimental | Other: Manual pressure groupIn the study group (n=25), pressure will be applied to the area to be injected for 10 seconds before the intramuscular injection procedure. |
| Control group | No intervention | –The control group (n=25) will not be subjected to any application other than intramuscular injection, which is routinely applied in pediatric emergency. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Having applied to the pediatric emergency service for the administration of a penicillin antibiotic group drug,
- Absence of a significant chronic disease,
- Absence of visual and auditory disabilities,
- Having no communication problems and being conscious,
- No previous history of fainting during injection,
Key exclusion criteria (6 listed)
- The percentile value is below 3 and the percentile value is above 97,
- Family's inability to cooperate in the assessment of pain and fear,
- Having a diagnosed physical or mental disability,
- To have taken analgesics in the last 3 hours,
- Presence of incision and scar tissue in the area to be injected,
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 glasses groupIt is suggested that the use of virtual reality glasses during the injection will positively affect the pain and fear levels in children who received penicillin injection in the pediatric emergency department where the study was conducted. | Other | Virtual reality glasses group |
| Manual pressure groupIn the pediatric emergency department where the study was conducted, pressure will be applied to the area to be injected for 10 seconds before the injection procedure in children who received penicillin injection. Pressing with the thumb of the hand, which will be passive in the pressing application, will be understood by the whitening of the nail, and thus pressure will be applied to the skin. It is suggested that it can positively affect pain and fear levels. | Other | Manual pressure group |
Primary outcome
Child Fear Scale
Time frame: The child's fear level will be evaluated by 3 people (child, parent and researcher) 2 minutes before intramuscular penicillin injection is given to the whole group. This process will take 1 minute.
The purpose of the Child Fear Scale is to evaluate the fear level of children. It consisted of five facial expressions ranging from neutral expression (0 = No anxiety) to fearful expression (4 = Severe anxiety).
1 secondary outcome
Facial Expressions Pain Scale-Revised
Time frame: Two minutes after intramuscular penicillin injection is given to the whole group, the child's pain will be evaluated by 3 people (child, parent and researcher). This process takes 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 5 Mar 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Due to Hospital policy, the individual participant data can not be shared with anyone except researchers.
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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.
EMINE KURTAR, RN principal investigator
Adana City Training and Research Hospital
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 group and Manual pressure group in people with Intramuscular Injection, run by Selmin Kose 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 9 inclusion and 6 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 5 Mar 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?
Child Fear Scale (time frame: The child's fear level will be evaluated by 3 people (child, parent and researcher) 2 minutes before intramuscular penicillin injection is given to the whole group. This process will take 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 5 Mar 2024.