PainNCT04970823
The Effect of Interactive Games on Children Receiving Intravenous Injection
A study testing The somatosensory interactive game for preschool children and A VR (virtual reality) game for school-age children in people with Pain and Fear, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Pediatric intravenous injection is one of the most painful events that children may be exposed to during hospitalization or illness, and it is also the most routinely performed invasive procedure. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- What is being tested?
- The somatosensory interactive game for preschool children and A VR (virtual reality) game for school-age children
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Mar 2021to 31 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 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 2-7 years old, normal consciousness, preschool children who need intravenous injection.
- 7-12 years old, normal consciousness, school-age children who need intravenous injection.
- Parents of children need to be conscious and able to talk in Chinese.
Who cannot join
- 2-7 years old preschool children with developmental delay, epilepsy, heart disease, chemotherapy, visual and hearing impaired, obese, and have received more than 2 intravenous injections.
- 7-12-year-old school-age children with developmental delay, epilepsy, heart disease, chemotherapy, visual and hearing impaired, obese, and have received more than 2 intravenous injections.
- The child's parents cannot express and communicate effectively.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Somatosensory Interactive Games on the Pain, Fear and Negative Emotions of Children Receiving Intravenous Injection
Pediatric intravenous injection is one of the most painful events that children may be exposed to during hospitalization or illness, and it is also the most routinely performed invasive procedure. The purpose of this study is to examine the effectiveness of somatosensory interactive games on intravenous pain relief for preschool children, and to establish a VR (virtual reality) game environment for school-age children. Using a randomized experimental study, the data came from the pediatric ward. The results will show whether there is a statistically significant difference between the experimental group and the control group.
Read the detailed description
Pediatric intravenous injection is one of the most painful events that children may be exposed to during hospitalization or illness, and it is also the most routinely performed invasive procedure. Non-pharmaceutical techniques can be used to relieve pain associated with intravenous injections. Distraction is a non-pharmacological technique that can take child's attention away from pain. The somatosensory interactive game is an independent nursing intervention that promotes pain relief. The purpose of this study is to examine the effectiveness of somatosensory interactive games on intravenous pain relief for preschool children, and to establish a VR (virtual reality) game environment for school-age children. Using a randomized experimental study, the data came from the pediatric ward. At least qualified 132 preschool children are in this study and their caregivers signed a consent form to participate in the study. Children are divided into experimental group and control group, and each group has at least 66 children. In addition to 60 school-age children, 30 played VR games for about 3 minutes during intravenous injection, and 30 received regular intravenous injection. The preschool experimental group and the school-age experimental group each took the parents of 5 children (10 in total) to conduct semi-structured qualitative interviews to understand the differences in experience before and after the intervention. This study is expected to accept a total of 202 children and parents. Data collection tools include WBFPS (Wong-Baker Faces Scale) to measure children's pain and CFS (Children's Fear scale) to measure children's fear. CEMS continue assessment negative emotion two days. The results will show whether there is a statistically significant difference between the experimental group and the control group. Qualitative study used semi-structed interviews were conducted with selected and their parent.
- Being tested
- The somatosensory interactive game for preschool children, A VR (virtual reality) game for school-age children
- Keywords
- school-age children, injection, pain, Somatosensory interactive games
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The somatosensory interactive game for preschool childrenDevice
The somatosensory interactive game, an independent nursing intervention, promotes pain relief for preschool children.
A VR (virtual reality) game for school-age childrenDevice
A VR (virtual reality) game environment promotes pain relief for school-age children.
| Study group | Role | What they receive |
|---|---|---|
| The somatosensory interactive game | Experimental | The somatosensory interactive game, an independent nursing intervention, promotes pain relief on the experimental group. Receives: Device: The somatosensory interactive game for preschool children |
| A VR (virtual reality) game | Experimental | A VR (virtual reality) game promotes pain relief on the experimental group. Receives: Device: A VR (virtual reality) game for school-age children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in children's pain from baseline to after intravenous injection
Using Wong-Baker Faces Pain Rating Scale to measure pain. There are 6 faces in the Wong-Baker Pain Scale. The first face represents a pain score of 0, and indicates "no hurt". The second face represents a pain score of 2, and indicates "hurts a little bit." The third face represents a pain score of 4, and indicates "hurts a little more". The fourth face represents a pain score of 6, and indicates "hurts even more". The fifth face represents a pain score of 8, and indicates "hurts a whole lot"; the sixth face represents a pain score of 10, and indicates "hurts worst." Nurses, pre-school children by the assistance of caregivers, and school-age children were asked to evaluate the pain levels experienced by the children receiving intravenous injections.
Measured: O1 (before intervention); O2 (immediately after intravenous injection); O3 (1 day after intravenous injection)
Changes in children's fear from baseline to after intravenous injection
Using Children's Fear scale to measure the fear level. Score the chosen face from 0 (the left-most face) to 4 (the last face). This face [point to the left-most face] shows no anxiety at all, this faces shows a little bit more [point to second face from left], a bit more [sweep finger along scale], right up to extreme anxiety [point to the last face on the right]. Nurses, pre-school children by the assistance of caregivers, and school-age children were asked to evaluate the fear levels experienced by the children receiving intravenous injections.
Measured: O1 (before intervention); O2 (immediately after intravenous injection); O3 (1 day after intravenous injection)
Changes in children's emotion from baseline to after intravenous injection
Using Children's Emotional Management Scales to measure the emotion level. The scale includes five observed emotional behavior categories, facial expression, vocalization, activity, interaction, and level of cooperation. Each category is scored from 1-5 points, the lowest total score is 5 points, and the highest score is 25 points. The higher the score, the more negative emotional behavior. Nurses, pre-school children by the assistance of caregivers, and school-age children were asked to evaluate the emotion levels experienced by the children receiving intravenous injections.
Measured: O1 (before intervention); O2 (immediately after intravenous injection); O3 (1 day after intravenous injection)
semi-structed interviews
After intravenous injection, a semi-structured qualitative interview was conducted with selected and their parent to understand the differences in experience before and after intervention.
Measured: immediately after intravenous injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start8 Mar 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui-Mei Chen, OTHERS, Principal investigator, NTUH Yunlin Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970823
- Sponsor's protocol ID
- 202012054RINC
- Status last verified
- Jan 2021
- First submitted
- 30 Jun 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Somatosensory Interactive Games on the Pain, Fear and Negative Emotions of Children Receiving Intravenous Injection
- ClinicalTrials.gov ID
- NCT04970823
- Acronym / sponsor ID
- 202012054RINC
- Keywords
- school-age children, injection, pain, Somatosensory interactive games
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 21 Jul 2021 (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.
Pediatric intravenous injection is one of the most painful events that children may be exposed to during hospitalization or illness, and it is also the most routinely performed invasive procedure. The purpose of this study is to examine the effectiveness of somatosensory interactive games on intravenous pain relief for preschool children, and to establish a VR (virtual reality) game environment for school-age children. Using a randomized experimental study, the data came from the pediatric ward. The results will show whether there is a statistically significant difference between the experimental group and the control group.
Detailed description
Pediatric intravenous injection is one of the most painful events that children may be exposed to during hospitalization or illness, and it is also the most routinely performed invasive procedure. Non-pharmaceutical techniques can be used to relieve pain associated with intravenous injections. Distraction is a non-pharmacological technique that can take child's attention away from pain. The somatosensory interactive game is an independent nursing intervention that promotes pain relief. The purpose of this study is to examine the effectiveness of somatosensory interactive games on intravenous pain relief for preschool children, and to establish a VR (virtual reality) game environment for school-age children. Using a randomized experimental study, the data came from the pediatric ward. At least qualified 132 preschool children are in this study and their caregivers signed a consent form to participate in the study. Children are divided into experimental group and control group, and each group has at least 66 children. In addition to 60 school-age children, 30 played VR games for about 3 minutes during intravenous injection, and 30 received regular intravenous injection. The preschool experimental group and the school-age experimental group each took the parents of 5 children (10 in total) to conduct semi-structured qualitative interviews to understand the differences in experience before and after the intervention. This study is expected to accept a total of 202 children and parents. Data collection tools include WBFPS (Wong-Baker Faces Scale) to measure children's pain and CFS (Children's Fear scale) to measure children's fear. CEMS continue assessment negative emotion two days. The results will show whether there is a statistically significant difference between the experimental group and the control group. Qualitative study used semi-structed interviews were conducted with selected and their parent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The somatosensory interactive game | Experimental | Device: The somatosensory interactive game for preschool childrenThe somatosensory interactive game, an independent nursing intervention, promotes pain relief on the experimental group. |
| A VR (virtual reality) game | Experimental | Device: A VR (virtual reality) game for school-age childrenA VR (virtual reality) game promotes pain relief on the experimental group. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 2-7 years old, normal consciousness, preschool children who need intravenous injection.
- 7-12 years old, normal consciousness, school-age children who need intravenous injection.
- Parents of children need to be conscious and able to talk in Chinese.
Key exclusion criteria (3 listed)
- 2-7 years old preschool children with developmental delay, epilepsy, heart disease, chemotherapy, visual and hearing impaired, obese, and have received more than 2 intravenous injections.
- 7-12-year-old school-age children with developmental delay, epilepsy, heart disease, chemotherapy, visual and hearing impaired, obese, and have received more than 2 intravenous injections.
- The child's parents cannot express and communicate effectively.
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 |
|---|---|---|
| The somatosensory interactive game for preschool childrenThe somatosensory interactive game, an independent nursing intervention, promotes pain relief for preschool children. | Device | The somatosensory interactive game |
| A VR (virtual reality) game for school-age childrenA VR (virtual reality) game environment promotes pain relief for school-age children. | Device | A VR (virtual reality) game |
Primary outcome
Changes in children's pain from baseline to after intravenous injection
Time frame: O1 (before intervention); O2 (immediately after intravenous injection); O3 (1 day after intravenous injection)
Using Wong-Baker Faces Pain Rating Scale to measure pain. There are 6 faces in the Wong-Baker Pain Scale. The first face represents a pain score of 0, and indicates "no hurt". The second face represents a pain score of 2, and indicates "hurts a little bit." The third face represents a pain score of 4, and indicates "hurts a little more". The fourth face represents a pain score of 6, and indicates "hurts even more". The fifth face represents a pain score of 8, and indicates "hurts a whole lot"; the sixth face represents a pain score of 10, and indicates "hurts worst." Nurses, pre-school children by the assistance of caregivers, and school-age children were asked to evaluate the pain levels experienced by the children receiving intravenous injections.
Changes in children's fear from baseline to after intravenous injection
Time frame: O1 (before intervention); O2 (immediately after intravenous injection); O3 (1 day after intravenous injection)
Using Children's Fear scale to measure the fear level. Score the chosen face from 0 (the left-most face) to 4 (the last face). This face [point to the left-most face] shows no anxiety at all, this faces shows a little bit more [point to second face from left], a bit more [sweep finger along scale], right up to extreme anxiety [point to the last face on the right]. Nurses, pre-school children by the assistance of caregivers, and school-age children were asked to evaluate the fear levels experienced by the children receiving intravenous injections.
Changes in children's emotion from baseline to after intravenous injection
Time frame: O1 (before intervention); O2 (immediately after intravenous injection); O3 (1 day after intravenous injection)
Using Children's Emotional Management Scales to measure the emotion level. The scale includes five observed emotional behavior categories, facial expression, vocalization, activity, interaction, and level of cooperation. Each category is scored from 1-5 points, the lowest total score is 5 points, and the highest score is 25 points. The higher the score, the more negative emotional behavior. Nurses, pre-school children by the assistance of caregivers, and school-age children were asked to evaluate the emotion levels experienced by the children receiving intravenous injections.
semi-structed interviews
Time frame: immediately after intravenous injection
After intravenous injection, a semi-structured qualitative interview was conducted with selected and their parent to understand the differences in experience before and after intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
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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.
Hui-Mei Chen, OTHERS principal investigator
NTUH Yunlin Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The somatosensory interactive game for preschool children and A VR (virtual reality) game for school-age children in people with Pain and Fear, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 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 21 Jul 2021. 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 Taiwan. 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?
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?
Changes in children's pain from baseline to after intravenous injection (time frame: O1 (before intervention); O2 (immediately after intravenous injection); O3 (1 day after intravenous injection)). The study lists 4 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 21 Jul 2021.