LacerationNCT06516003
VR for Lac Repairs in Peds Emergency Department
A study testing Immersive Virtual Reality Goggles in people with Laceration, run by Eastern Virginia Medical School at 1 site in United States.
Trial summary
The goal of the clinical trial is to compare virtual reality to standard of care for laceration repairs in the pediatric emergency department. The main question it aims to answer is: -Does virtual reality decrease pain and anxiety scores compared to standard of care for laceration repairs in the pediatric emergency… Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Laceration
- What is being tested?
- Immersive Virtual Reality Goggles
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 30 Mar 2023
- 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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Simple lacerations that do not require surgical subspecialty repair or moderate or deep sedation
- Hand lacerations
- Laceration that required stitches
Who cannot join
- less than 6 years old or greater than 17 years old
- Non english speaking
- Visual or hearing impairment
- Epilepsy
- Lacerations to forehead, nose, or cheeks where goggles cover
- Intellectual disability that precludes participation as determined by guardian
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507
About this study
Official title: Use of Immersive Virtual Reality for Laceration Repairs in the Pediatric Emergency Department
The goal of the clinical trial is to compare virtual reality to standard of care for laceration repairs in the pediatric emergency department. The main question it aims to answer is:
-Does virtual reality decrease pain and anxiety scores compared to standard of care for laceration repairs in the pediatric emergency department?
Participants who meet the age and other inclusion criteria will be enrolled by research staff. They will complete a brief paper survey along with their guardians and the provider doing the laceration repair. The surveys will be completed after the laceration repair is finished.
Read the detailed description
This will be a randomized pragmatic study for all patients ages 6-17 years with simple lacerations. Simple lacerations will be defined as lacerations within the scope of pediatric emergency medicine providers AND not requiring sedation or operative intervention. Subjects will be identified by the Emergency Department staff for enrollment. The goal number of enrolled participants will be 480, including 240 patients randomized into two groups, 120 per group, and 240 parents/guardians. The Emergency Department accepted to participate in this study and ED providers will complete the provider's survey. After signing the consent and assent form when appropriate, the patients will be randomized to either receive the standard of care or standard or care with immersive virtual reality goggles. Consent and assent will be obtained in the patient rooms within the emergency department. The standard of care shall be defined to include any of the following: local analgesia (topical LET and/ or subcutaneous lidocaine), oral or intranasal midazolam, distraction, Child Life Staff, or physical holding. Because each of the aforementioned interventions may vary between patients, it cannot be truly standardized; hence, this will be considered a pragmatic study. Patients randomized to the VR arm will receive the other standard procedures as well with VR goggles as an adjunct. Exclusion criteria include a history of epilepsy, visual or hearing impairment, or intellectual disability that would preclude use of VR goggles as determined by the guardian. Additionally, any lacerations around the eyes, eyebrows, and nose will be excluded as well as patients requiring sedation. Non-English speaking patients will be excluded as well. Hand lacerations will not be excluded.
Participants will be identified by ED staff following evaluation of the laceration. The ED staff will be given a flowchart with eligibility criteria. All interested participants who meet eligibility criteria will be consented. A research team member will obtain consent from parents or guardians by providing and reviewing the consent form (see Subject Consent Form). For patients who are between 8 and 17 years of age, a research team member will obtain assent by providing and reviewing the assent form (see Subject Assent Form). Consent and assent will be obtained in the patient's ED room.
Patients will be separated into groups age 6-11 and 12-17. Patients will be randomized via a selection of a sealed envelope which will contain instructions for use of the VR goggles. The goggles utilized will be Lenovo Mirage Solo with DayDream, which are standalone VR headset with Worldsense Body Tracking. Research staff will coach the child on age-appropriate games, as previously determined by Lenovo.
The goggles will be cleansed with Oxivir Tb disinfectant wipes after each use and allowed to dry in room air prior to next use. Education will be provided to all ED providers on the proper cleansing protocol for the VR goggles (Figure 4). The disinfectant protocol will be available for all users during the study, and has been approved by the director of Infection Control at Children's Hospital of the King's Daughters.
Following the laceration repair, the patient, guardian and health care provider will be surveyed (Figure 1, 2, and 3) on paper surveys. The survey includes Likert-type scale questions, binary questions as well as incorporates the Wong Baker Faces Pain Scale and Children's Fear Scale. The duration of the procedure will be recorded by the healthcare provider who completed the laceration repair. Time of procedure will be defined as from the time of irrigation to wound dressing. Patients and parents will both be filling out their own individual surveys. The parent should complete the survey first before the child should the child need assistance with completion. Patients and parents may decline to participate in any survey at any time
- Conditions
- Laceration
- Being tested
- Immersive Virtual Reality Goggles, Standard of Care
- Keywords
- virtual reality, pediatrics, emergency department
- Medical subject headings
- Lacerations, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual Reality GogglesDevice
Immersive Virtual Reality goggles are a head mounted device placed over a patient's head and eyes that allows them to play in a virtual reality game.
Standard of CareBehavioural
Distraction techniques like tablet, phone, television, parent, child life specialist
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Patients randomized to receive virtual reality goggles in addition to the standard of care. Receives: Device: Immersive Virtual Reality Goggles |
| Standard of Care | Active comparator | Patients that are randomized to receive the standard of care including other distraction techniques and child life specialist. Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Using Wong Baker Faces Pain Scale
Measured: Assessed immediately after intervention
Fear Score
Using Children's Fear Score
Measured: Assessed immediately after intervention
Secondary outcomes (6)
Satisfaction of procedure
Assessed by Likert- type scale question
Measured: Assessed immediately after intervention
Side Effects
nausea, vomiting, dizziness, headache, other
Measured: Assessed immediately after intervention
Duration of procedure
Five minute intervals up to 25 minutes
Measured: Assessed immediately after intervention
Future Use
Would they recommend use of VR for same procedure again
Measured: Assessed immediately after intervention
Physical Holding
Did patient need to be held for the procedure
Measured: Assessed immediately after intervention
Anxiolytic Use
Did patient need anxiolytics for the procedure
Measured: Assessed immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Feb 2022
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for LacerationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516003
- Sponsor's protocol ID
- 29-01-FB-0211
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not planning to share data with other researchers
Publications
Martin SR, Heyming TW, Fortier MA, Kain ZN. Paediatric laceration repair in the emergency department: post-discharge pain and maladaptive behavioural changes. Emerg Med J. 2024 Jul 22;41(8):469-474. doi: 10.1136/emermed-2023-213858.
PubMed 38724104Ploghaus A, Narain C, Beckmann CF, Clare S, Bantick S, Wise R, Matthews PM, Rawlins JN, Tracey I. Exacerbation of pain by anxiety is associated with activity in a hippocampal network. J Neurosci. 2001 Dec 15;21(24):9896-903. doi: 10.1523/JNEUROSCI.21-24-09896.2001.
PubMed 11739597Chan E, Hovenden M, Ramage E, Ling N, Pham JH, Rahim A, Lam C, Liu L, Foster S, Sambell R, Jeyachanthiran K, Crock C, Stock A, Hopper SM, Cohen S, Davidson A, Plummer K, Mills E, Craig SS, Deng G, Leong P. Virtual Reality for Pediatric Needle Procedural Pain: Two Randomized Clinical Trials. J Pediatr. 2019 Jun;209:160-167.e4. doi: 10.1016/j.jpeds.2019.02.034. Epub 2019 Apr 29.
PubMed 31047650Kumar K, Ali S, Sabhaney V, Trottier E, Drendel A, Bhatt M, Boisvert L, Poonai N; Pediatric Emergency Research Canada. Anxiolysis for laceration repair in children: a survey of pediatric emergency providers in Canada. CJEM. 2022 Jan;24(1):75-83. doi: 10.1007/s43678-021-00210-y. Epub 2021 Nov 8.
PubMed 34746980Ali S, McGrath T, Drendel AL. An Evidence-Based Approach to Minimizing Acute Procedural Pain in the Emergency Department and Beyond. Pediatr Emerg Care. 2016 Jan;32(1):36-42; quiz 43-4. doi: 10.1097/PEC.0000000000000669.
PubMed 26720064Arikan A, Esenay FI. Active and Passive Distraction Interventions in a Pediatric Emergency Department to Reduce the Pain and Anxiety During Venous Blood Sampling: A Randomized Clinical Trial. J Emerg Nurs. 2020 Nov;46(6):779-790. doi: 10.1016/j.jen.2020.05.004. Epub 2020 Jul 22.
PubMed 32711948Aykanat Girgin B, Gol I. Reducing Pain and Fear in Children During Venipuncture: A Randomized Controlled Study. Pain Manag Nurs. 2020 Jun;21(3):276-282. doi: 10.1016/j.pmn.2019.07.006. Epub 2019 Sep 26.
PubMed 31501078Eijlers R, Utens EMWJ, Staals LM, de Nijs PFA, Berghmans JM, Wijnen RMH, Hillegers MHJ, Dierckx B, Legerstee JS. Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. Anesth Analg. 2019 Nov;129(5):1344-1353. doi: 10.1213/ANE.0000000000004165.
PubMed 31136330Won AS, Bailey J, Bailenson J, Tataru C, Yoon IA, Golianu B. Immersive Virtual Reality for Pediatric Pain. Children (Basel). 2017 Jun 23;4(7):52. doi: 10.3390/children4070052.
PubMed 28644422Arane K, Behboudi A, Goldman RD. Virtual reality for pain and anxiety management in children. Can Fam Physician. 2017 Dec;63(12):932-934.
PubMed 29237632Piskorz J, Czub M. Effectiveness of a virtual reality intervention to minimize pediatric stress and pain intensity during venipuncture. J Spec Pediatr Nurs. 2018 Jan;23(1). doi: 10.1111/jspn.12201. Epub 2017 Nov 20.
PubMed 29155488Thomas JJ, Albietz J, Polaner D. Virtual reality for lumbar puncture in a morbidly obese patient with leukemia. Paediatr Anaesth. 2018 Nov;28(11):1059-1060. doi: 10.1111/pan.13505. Epub 2018 Oct 4.
PubMed 30284748Hoffman HG, Rodriguez RA, Gonzalez M, Bernardy M, Pena R, Beck W, Patterson DR, Meyer WJ 3rd. Immersive Virtual Reality as an Adjunctive Non-opioid Analgesic for Pre-dominantly Latin American Children With Large Severe Burn Wounds During Burn Wound Cleaning in the Intensive Care Unit: A Pilot Study. Front Hum Neurosci. 2019 Aug 8;13:262. doi: 10.3389/fnhum.2019.00262. eCollection 2019.
PubMed 31440148Chad R, Emaan S, Jillian O. Effect of virtual reality headset for pediatric fear and pain distraction during immunization. Pain Manag. 2018 May;8(3):175-179. doi: 10.2217/pmt-2017-0040. Epub 2018 May 3.
PubMed 29722606Shetty V, Suresh LR, Hegde AM. Effect of Virtual Reality Distraction on Pain and Anxiety During Dental Treatment in 5 to 8 Year Old Children. J Clin Pediatr Dent. 2019;43(2):97-102. doi: 10.17796/1053-4625-43.2.5. Epub 2019 Feb 7.
PubMed 30730798
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Immersive Virtual Reality for Laceration Repairs in the Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT06516003
- Acronym / sponsor ID
- 29-01-FB-0211
- Conditions
- Laceration
- Keywords
- virtual reality, pediatrics, emergency department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 23 Jul 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 goal of the clinical trial is to compare virtual reality to standard of care for laceration repairs in the pediatric emergency department. The main question it aims to answer is:
-Does virtual reality decrease pain and anxiety scores compared to standard of care for laceration repairs in the pediatric emergency department?
Participants who meet the age and other inclusion criteria will be enrolled by research staff. They will complete a brief paper survey along with their guardians and the provider doing the laceration repair. The surveys will be completed after the laceration repair is finished.
Detailed description
This will be a randomized pragmatic study for all patients ages 6-17 years with simple lacerations. Simple lacerations will be defined as lacerations within the scope of pediatric emergency medicine providers AND not requiring sedation or operative intervention. Subjects will be identified by the Emergency Department staff for enrollment. The goal number of enrolled participants will be 480, including 240 patients randomized into two groups, 120 per group, and 240 parents/guardians. The Emergency Department accepted to participate in this study and ED providers will complete the provider's survey. After signing the consent and assent form when appropriate, the patients will be randomized to either receive the standard of care or standard or care with immersive virtual reality goggles. Consent and assent will be obtained in the patient rooms within the emergency department. The standard of care shall be defined to include any of the following: local analgesia (topical LET and/ or subcutaneous lidocaine), oral or intranasal midazolam, distraction, Child Life Staff, or physical holding. Because each of the aforementioned interventions may vary between patients, it cannot be truly standardized; hence, this will be considered a pragmatic study. Patients randomized to the VR arm will receive the other standard procedures as well with VR goggles as an adjunct. Exclusion criteria include a history of epilepsy, visual or hearing impairment, or intellectual disability that would preclude use of VR goggles as determined by the guardian. Additionally, any lacerations around the eyes, eyebrows, and nose will be excluded as well as patients requiring sedation. Non-English speaking patients will be excluded as well. Hand lacerations will not be excluded.
Participants will be identified by ED staff following evaluation of the laceration. The ED staff will be given a flowchart with eligibility criteria. All interested participants who meet eligibility criteria will be consented. A research team member will obtain consent from parents or guardians by providing and reviewing the consent form (see Subject Consent Form). For patients who are between 8 and 17 years of age, a research team member will obtain assent by providing and reviewing the assent form (see Subject Assent Form). Consent and assent will be obtained in the patient's ED room.
Patients will be separated into groups age 6-11 and 12-17. Patients will be randomized via a selection of a sealed envelope which will contain instructions for use of the VR goggles. The goggles utilized will be Lenovo Mirage Solo with DayDream, which are standalone VR headset with Worldsense Body Tracking. Research staff will coach the child on age-appropriate games, as previously determined by Lenovo.
The goggles will be cleansed with Oxivir Tb disinfectant wipes after each use and allowed to dry in room air prior to next use. Education will be provided to all ED providers on the proper cleansing protocol for the VR goggles (Figure 4). The disinfectant protocol will be available for all users during the study, and has been approved by the director of Infection Control at Children's Hospital of the King's Daughters.
Following the laceration repair, the patient, guardian and health care provider will be surveyed (Figure 1, 2, and 3) on paper surveys. The survey includes Likert-type scale questions, binary questions as well as incorporates the Wong Baker Faces Pain Scale and Children's Fear Scale. The duration of the procedure will be recorded by the healthcare provider who completed the laceration repair. Time of procedure will be defined as from the time of irrigation to wound dressing. Patients and parents will both be filling out their own individual surveys. The parent should complete the survey first before the child should the child need assistance with completion. Patients and parents may decline to participate in any survey at any time
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Device: Immersive Virtual Reality GogglesPatients randomized to receive virtual reality goggles in addition to the standard of care. |
| Standard of Care | Active comparator | Behavioral: Standard of CarePatients that are randomized to receive the standard of care including other distraction techniques and child life specialist. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Simple lacerations that do not require surgical subspecialty repair or moderate or deep sedation
- Hand lacerations
- Laceration that required stitches
Key exclusion criteria (6 listed)
- less than 6 years old or greater than 17 years old
- Non english speaking
- Visual or hearing impairment
- Epilepsy
- Lacerations to forehead, nose, or cheeks where goggles cover
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 |
|---|---|---|
| Immersive Virtual Reality GogglesImmersive Virtual Reality goggles are a head mounted device placed over a patient's head and eyes that allows them to play in a virtual reality game. | Device | Virtual Reality |
| Standard of CareDistraction techniques like tablet, phone, television, parent, child life specialist | Behavioural | Standard of Care |
Primary outcome
Pain Score
Time frame: Assessed immediately after intervention
Using Wong Baker Faces Pain Scale
Fear Score
Time frame: Assessed immediately after intervention
Using Children's Fear Score
6 secondary outcomes
Satisfaction of procedure
Time frame: Assessed immediately after intervention
Side Effects
Time frame: Assessed immediately after intervention
Duration of procedure
Time frame: Assessed immediately after intervention
Future Use
Time frame: Assessed immediately after intervention
Physical Holding
Time frame: Assessed immediately after intervention
Anxiolytic Use
Time frame: Assessed immediately after intervention
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 23 Jul 2024.
- Background: PubMed 38724104Martin SR, Heyming TW, Fortier MA, Kain ZN. Paediatric laceration repair in the emergency department: post-discharge pain and maladaptive behavioural changes. Emerg Med J. 2024 Jul 22;41(8):469-474. doi: 10.1136/emermed-2023-213858.
- Background: PubMed 11739597Ploghaus A, Narain C, Beckmann CF, Clare S, Bantick S, Wise R, Matthews PM, Rawlins JN, Tracey I. Exacerbation of pain by anxiety is associated with activity in a hippocampal network. J Neurosci. 2001 Dec 15;21(24):9896-903. doi: 10.1523/JNEUROSCI.21-24-09896.2001.
- Background: PubMed 31047650Chan E, Hovenden M, Ramage E, Ling N, Pham JH, Rahim A, Lam C, Liu L, Foster S, Sambell R, Jeyachanthiran K, Crock C, Stock A, Hopper SM, Cohen S, Davidson A, Plummer K, Mills E, Craig SS, Deng G, Leong P. Virtual Reality for Pediatric Needle Procedural Pain: Two Randomized Clinical Trials. J Pediatr. 2019 Jun;209:160-167.e4. doi: 10.1016/j.jpeds.2019.02.034. Epub 2019 Apr 29.
- Background: PubMed 34746980Kumar K, Ali S, Sabhaney V, Trottier E, Drendel A, Bhatt M, Boisvert L, Poonai N; Pediatric Emergency Research Canada. Anxiolysis for laceration repair in children: a survey of pediatric emergency providers in Canada. CJEM. 2022 Jan;24(1):75-83. doi: 10.1007/s43678-021-00210-y. Epub 2021 Nov 8.
- Background: PubMed 26720064Ali S, McGrath T, Drendel AL. An Evidence-Based Approach to Minimizing Acute Procedural Pain in the Emergency Department and Beyond. Pediatr Emerg Care. 2016 Jan;32(1):36-42; quiz 43-4. doi: 10.1097/PEC.0000000000000669.
- Background: PubMed 32711948Arikan A, Esenay FI. Active and Passive Distraction Interventions in a Pediatric Emergency Department to Reduce the Pain and Anxiety During Venous Blood Sampling: A Randomized Clinical Trial. J Emerg Nurs. 2020 Nov;46(6):779-790. doi: 10.1016/j.jen.2020.05.004. Epub 2020 Jul 22.
- Background: PubMed 31501078Aykanat Girgin B, Gol I. Reducing Pain and Fear in Children During Venipuncture: A Randomized Controlled Study. Pain Manag Nurs. 2020 Jun;21(3):276-282. doi: 10.1016/j.pmn.2019.07.006. Epub 2019 Sep 26.
- Background: PubMed 31136330Eijlers R, Utens EMWJ, Staals LM, de Nijs PFA, Berghmans JM, Wijnen RMH, Hillegers MHJ, Dierckx B, Legerstee JS. Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. Anesth Analg. 2019 Nov;129(5):1344-1353. doi: 10.1213/ANE.0000000000004165.
- Background: PubMed 28644422Won AS, Bailey J, Bailenson J, Tataru C, Yoon IA, Golianu B. Immersive Virtual Reality for Pediatric Pain. Children (Basel). 2017 Jun 23;4(7):52. doi: 10.3390/children4070052.
- Background: PubMed 29237632Arane K, Behboudi A, Goldman RD. Virtual reality for pain and anxiety management in children. Can Fam Physician. 2017 Dec;63(12):932-934.
- Background: PubMed 29155488Piskorz J, Czub M. Effectiveness of a virtual reality intervention to minimize pediatric stress and pain intensity during venipuncture. J Spec Pediatr Nurs. 2018 Jan;23(1). doi: 10.1111/jspn.12201. Epub 2017 Nov 20.
- Background: PubMed 30284748Thomas JJ, Albietz J, Polaner D. Virtual reality for lumbar puncture in a morbidly obese patient with leukemia. Paediatr Anaesth. 2018 Nov;28(11):1059-1060. doi: 10.1111/pan.13505. Epub 2018 Oct 4.
- Individual participant dataSharing planned: No. Not planning to share data with other 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.
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 Immersive Virtual Reality Goggles in people with Laceration, run by Eastern Virginia Medical School at 1 site in United States.
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 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 23 Jul 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 United States. 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 Score (time frame: Assessed immediately after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06516003, which also lists 21 linked publications.
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 23 Jul 2024.