Procedural PainNCT06354608
The Effect of Audio Book and Local Vibration on Pain and Fear in Intramuscular Injection in Children
A study testing Audio Book Group and Local Vibration Group in people with Procedural Pain, run by University of Yalova at 1 site in Turkey (Türkiye).
Trial summary
The study is conducted based on a randomized controlled experimental design to determine the effect of an audio book and local vibration on intramuscular injection in pediatric emergency unit patients aged 4-6 years on pain and fear. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedural Pain
- What is being tested?
- Audio Book Group and Local Vibration Group
- Type of treatment
- Injection or infusion, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Oct 2023to 1 Jul 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The child and family agree to participate in the research,
- The child is between the ages of 4-6,
- The child does not have a chronic and mental health problem,
- Absence of visual, auditory problems or mental retardation at a level that can fill the scales,
- No history of sedative, analgesic or narcotic substance use within 24 hours before admission,
- Absence of a disease causing chronic pain,
Show all 11Show fewer
- Not having a febrile illness at the time of application,
- Being treated in the pediatric emergency unıt at the time of the study,
- Intramuscular injection in the vastus lateralis region,
- Ondansetron will be injected intramuscularly in the vastus lateralis area, as directed by the doctor.
- Performing the operation at once.
Who cannot join
- The child and family's refusal to participate in the research,
- Having a visual and auditory problem
- The child is less than 4 years old or older than 6 years old
- The child has a chronic and mental health problem
- The child experiences pain,
- To have taken analgesic medication in the last 6 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Audio Book and Local Vibration on Pain and Fear in Intramuscular Injection in Children: A Randomised Controlled Study
The study is conducted based on a randomized controlled experimental design to determine the effect of an audio book and local vibration on intramuscular injection in pediatric emergency unit patients aged 4-6 years on pain and fear.
Read the detailed description
IM injection is one of the medical procedures that causes pain and fear in children. It has been reported that the effect of children's previous pain and fearful experiences continues into adulthood, and this may lead to the avoidance of subsequent medical procedures as a reaction to increased pain and fear. For all these reasons, pediatric nurses and other healthcare professionals should aim for successful pain control before and during painful procedures in children to prevent future adverse effects of painful medical procedures.
Reducing the emotional impact of painful procedures in clinical practice through better pain control is very important for children. Therefore, all healthcare professionals, especially nurses, as the first person to welcome children into the hospital and the person who spends the most time with the child, have important responsibilities in eliminating children's fear of medical procedures. It is very important for pediatric nurses to use nonpharmacological techniques to reduce pain in the IM injection procedure. It is known that non-pharmacological pain control methods help the child cope with pain, reduce pain, and alleviate distress from invasive procedures. The most commonly used of these approaches is the distraction technique, also known as the distraction technique, which is constructed with cognitive and behavioral processes. These include relaxation techniques, deep breathing, listening to music, singing and talking, watching cartoons, games, vibration and cold applications, and distraction cards. As understood from the studies, nonpharmacological approaches help the child cope with the pain experienced in invasive interventions and provide less pain.
It is critical that all pediatric nurses and other healthcare workers who work with children learn about and practice pain-reduction techniques. When the literature was reviewed, it was discovered that there were no studies comparing audiobook and local vibration application to reduce pain and fear perceived during IM injections administered to pediatric patients, whereas there were a limited number of studies evaluating the methods independently. It is thought that there is a need for planning randomized controlled experimental nursing studies in this field. This study is planned to determine the effect of the use of audio book and local vibration on the pain and fear experienced by children during intramuscular injection in children aged 4-6 years. While the population of the study consisted of pediatric patients aged 4-6 years in the pediatric emergency unit between October 2023 and April 2024, the sample consisted of 120 children who met the sample selection criteria. The research consists of 3 groups. These groups will audio book group (n=40), local vibration group (n=40), and control group (n=40). In order for the groups to be distributed homogeneously, the order produced by a computer program (http://www.randomization.com, Balanced permutation) was used. Patients who meet the inclusion criteria and agree to participate in the study assigned to the experimental and control groups according the randomization list. The control variable of the study is demographic characteristics of the children. The dependent variables of the study are pain and fear score. The data are collected using Introductory Information Form, Wong-Baker FACES Pain Scale (W-BPS), Children's Fear Scale (CFS).
- Conditions
- Procedural Pain
- Being tested
- Audio Book Group, Local Vibration Group
- Keywords
- Audio Book, Vibration, Intramuscular Injection, pediatric emergency, Child, pain, fear
- Medical subject headings
- Pain, Procedural, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audio Book GroupBehavioural
Audiobook will be applied during the entire IM injection procedure and until the end of the procedure. After the procedure is over, the children will be taken to the waiting area. After being allowed to rest for 1-2 minutes, the child will be asked to rate their level of pain and fear during the procedure. A parent who is with the child and observes the child's behavior, and the same nurse who is independent from the study, will independently rate the child's pain and fear level during the procedure.
Local Vibration GroupDevice
In the local vibration group, IM injection will be performed with a vibrating massage device. After the procedure is finished, the children will be taken to the waiting section. After being allowed to rest for 1-2 minutes, the child will be asked to rate their level of pain and fear during the procedure. A parent who is with the child and observes the child's behavior and the same nurse who is independent from the study will independently rate the pain and fear level of the child during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Audio Book Group | Experimental | Audiobooks are stories with illustrated stories, and these stories are voiced. Audiobooks are visual and auditory distractions. The researcher will introduce this audio book to both children and parents before the procedure. The child will be allowed to examine the book. Before starting the IM injection procedure, the researcher will show the pages of the book and start the story. The story will be supported by showing the pictures in the book to attract the child's attention. After the child concentrates on the story, the child's leg area where the vastus lateralis muscle is located will be hygienized before the IM injection. During the entire IM injection procedure, the audiobook will continue until the end of the procedure. Receives: Behavioral: Audio Book Group |
| Local Vibration Group | Experimental | A local vibration device, an electric vibration device, will be used. During the application, the device must be in full contact with the skin. Local vibration application reduces perceived pain by stimulating nerve fibres according to Melzack and Wall's Gate Control Theory. In the local vibration group, local vibration is applied to the leg area of the child where the vastus lateralis muscle is located for 30 seconds before the IM injection is applied with the vibrating Dolphin massage device. Then, the leg area will be hygienized, and the device will be placed 3-5 cm above the injection area during the procedure, and IM injection will be performed. The device must be in full contact with the skin during the application. Receives: Device: Local Vibration Group |
| Control Group | No intervention | Children in the control group will be received standard care. Control group children will not receive any distraction techniques. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the pain score values of the groups Pain assesed by Wong-Baker FACES
The Wong-Baker Faces Pain Scale revised (W-BFS) is used to determine the level of pain during the procedure. The W-BFS is a scale that is most commonly used in identifying pain in children of the ages 3 to 18. It is reported that the scale is reliable when used with children older than the age of 3 who can verbally express the degree of pain they feel. The scale is made up of faces and numbers. Pain is assessed on a scale of "0" to "10." Pain is described by selecting the facial expression depicting the degree of perceived pain. This scale will be assessed independently by the child, a parent who is present and observes the child's behavior, and the same nurse who is independent of the study.
Measured: Pain levels of the children will be evaluated 1 minute after the procedure.
Comparison of the fear score values of the groups
The Children's Fear Scale (CFS) is used to measure the child's fear level. This scale is a one-item self-report measure for measuring pain-related fear in children. The CFS is a scale from 0 to 4, showing 5 facial expressions ranging from a neutral expression (0 = no anxiety) to a frightened face (4=severe anxiety). CFS is administered by the researcher to the children to assess their fear levels before and after the IM procedure.
Measured: Children's fear levels will be evaluated first 1 minutes before the procedure.
Comparison of the fear score values of the groups
The Children's Fear Scale (CFS) is used to measure the child's fear level. This scale is a one-item self-report measure for measuring pain-related fear in children. The CFS is a scale from 0 to 4, showing 5 facial expressions ranging from a neutral expression (0 = no anxiety) to a frightened face (4=severe anxiety). CFS is administered by the researcher to the children to assess their fear levels before and after the IM procedure.
Measured: Children's fear levels will be evaluated 1 minutes 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 posted9 Apr 2024
- Study start25 Oct 2023
- Primary completion21 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is an experimental, parallel-group (intervention-control), randomized controlled design
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Yalova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Demir, University of Yalova
- Investigators
- Duygu Demir, Assis. Prof., Study director, DirectorDerya Kılıç, Assis. Prof., Principal investigator, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354608
- Sponsor's protocol ID
- duygudemirr
- Status last verified
- May 2026
- First submitted
- 12 Mar 2024
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
PubMed 21806301Gerceker GO, Binay S, Bilsin E, Kahraman A, Yilmaz HB. Effects of Virtual Reality and External Cold and Vibration on Pain in 7- to 12-Year-Old Children During Phlebotomy: A Randomized Controlled Trial. J Perianesth Nurs. 2018 Dec;33(6):981-989. doi: 10.1016/j.jopan.2017.12.010. Epub 2018 Mar 17.
PubMed 29559294Ozalp Gerceker G, Ayar D, Ozdemir EZ, Bektas M. Effects of virtual reality on pain, fear and anxiety during blood draw in children aged 5-12 years old: A randomised controlled study. J Clin Nurs. 2020 Apr;29(7-8):1151-1161. doi: 10.1111/jocn.15173. Epub 2020 Jan 22.
PubMed 31889358Sivri Bilgen B, Balci S. The Effect on Pain of Buzzy(R) and ShotBlocker(R) during the Administration of Intramuscular Injections to Children: A Randomized Controlled Trial. J Korean Acad Nurs. 2019 Aug;49(4):486-494. doi: 10.4040/jkan.2019.49.4.486.
PubMed 31477677Sunitha Suresh BS, De Oliveira GS Jr, Suresh S. The effect of audio therapy to treat postoperative pain in children undergoing major surgery: a randomized controlled trial. Pediatr Surg Int. 2015 Feb;31(2):197-201. doi: 10.1007/s00383-014-3649-9. Epub 2015 Jan 3.
PubMed 25555856
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Audio Book and Local Vibration on Pain and Fear in Intramuscular Injection in Children: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06354608
- Acronym / sponsor ID
- duygudemirr
- Conditions
- Procedural Pain
- Keywords
- Audio Book, Vibration, Intramuscular Injection, pediatric emergency, Child, pain, fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of YalovaUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 9 Apr 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 study is conducted based on a randomized controlled experimental design to determine the effect of an audio book and local vibration on intramuscular injection in pediatric emergency unit patients aged 4-6 years on pain and fear.
Detailed description
IM injection is one of the medical procedures that causes pain and fear in children. It has been reported that the effect of children's previous pain and fearful experiences continues into adulthood, and this may lead to the avoidance of subsequent medical procedures as a reaction to increased pain and fear. For all these reasons, pediatric nurses and other healthcare professionals should aim for successful pain control before and during painful procedures in children to prevent future adverse effects of painful medical procedures.
Reducing the emotional impact of painful procedures in clinical practice through better pain control is very important for children. Therefore, all healthcare professionals, especially nurses, as the first person to welcome children into the hospital and the person who spends the most time with the child, have important responsibilities in eliminating children's fear of medical procedures. It is very important for pediatric nurses to use nonpharmacological techniques to reduce pain in the IM injection procedure. It is known that non-pharmacological pain control methods help the child cope with pain, reduce pain, and alleviate distress from invasive procedures. The most commonly used of these approaches is the distraction technique, also known as the distraction technique, which is constructed with cognitive and behavioral processes. These include relaxation techniques, deep breathing, listening to music, singing and talking, watching cartoons, games, vibration and cold applications, and distraction cards. As understood from the studies, nonpharmacological approaches help the child cope with the pain experienced in invasive interventions and provide less pain.
It is critical that all pediatric nurses and other healthcare workers who work with children learn about and practice pain-reduction techniques. When the literature was reviewed, it was discovered that there were no studies comparing audiobook and local vibration application to reduce pain and fear perceived during IM injections administered to pediatric patients, whereas there were a limited number of studies evaluating the methods independently. It is thought that there is a need for planning randomized controlled experimental nursing studies in this field. This study is planned to determine the effect of the use of audio book and local vibration on the pain and fear experienced by children during intramuscular injection in children aged 4-6 years. While the population of the study consisted of pediatric patients aged 4-6 years in the pediatric emergency unit between October 2023 and April 2024, the sample consisted of 120 children who met the sample selection criteria. The research consists of 3 groups. These groups will audio book group (n=40), local vibration group (n=40), and control group (n=40). In order for the groups to be distributed homogeneously, the order produced by a computer program (http://www.randomization.com, Balanced permutation) was used. Patients who meet the inclusion criteria and agree to participate in the study assigned to the experimental and control groups according the randomization list. The control variable of the study is demographic characteristics of the children. The dependent variables of the study are pain and fear score. The data are collected using Introductory Information Form, Wong-Baker FACES Pain Scale (W-BPS), Children's Fear Scale (CFS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study is an experimental, parallel-group (intervention-control), randomized controlled design
| Arm | Type | Receives |
|---|---|---|
| Audio Book Group | Experimental | Behavioral: Audio Book GroupAudiobooks are stories with illustrated stories, and these stories are voiced. Audiobooks are visual and auditory distractions. The researcher will introduce this audio book to both children and parents before the procedure. The child will be allowed to examine the book. Before starting the IM injection procedure, the researcher will show the pages of the book and start the story. The story will be supported by showing the pictures in the book to attract the child's attention. After the child concentrates on the story, the child's leg area where the vastus lateralis muscle is located will be hygienized before the IM injection. During the entire IM injection procedure, the audiobook will continue until the end of the procedure. |
| Local Vibration Group | Experimental | Device: Local Vibration GroupA local vibration device, an electric vibration device, will be used. During the application, the device must be in full contact with the skin. Local vibration application reduces perceived pain by stimulating nerve fibres according to Melzack and Wall's Gate Control Theory. In the local vibration group, local vibration is applied to the leg area of the child where the vastus lateralis muscle is located for 30 seconds before the IM injection is applied with the vibrating Dolphin massage device. Then, the leg area will be hygienized, and the device will be placed 3-5 cm above the injection area during the procedure, and IM injection will be performed. The device must be in full contact with the skin during the application. |
| Control Group | No intervention | –Children in the control group will be received standard care. Control group children will not receive any distraction techniques. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- The child and family agree to participate in the research,
- The child is between the ages of 4-6,
- The child does not have a chronic and mental health problem,
- Absence of visual, auditory problems or mental retardation at a level that can fill the scales,
- No history of sedative, analgesic or narcotic substance use within 24 hours before admission,
Key exclusion criteria (6 listed)
- The child and family's refusal to participate in the research,
- Having a visual and auditory problem
- The child is less than 4 years old or older than 6 years old
- The child has a chronic and mental health problem
- The child experiences pain,
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 |
|---|---|---|
| Audio Book GroupAudiobook will be applied during the entire IM injection procedure and until the end of the procedure. After the procedure is over, the children will be taken to the waiting area. After being allowed to rest for 1-2 minutes, the child will be asked to rate their level of pain and fear during the procedure. A parent who is with the child and observes the child's behavior, and the same nurse who is independent from the study, will independently rate the child's pain and fear level during the procedure. | Behavioural | Audio Book Group |
| Local Vibration GroupIn the local vibration group, IM injection will be performed with a vibrating massage device. After the procedure is finished, the children will be taken to the waiting section. After being allowed to rest for 1-2 minutes, the child will be asked to rate their level of pain and fear during the procedure. A parent who is with the child and observes the child's behavior and the same nurse who is independent from the study will independently rate the pain and fear level of the child during the procedure. | Device | Local Vibration Group |
Primary outcome
Comparison of the pain score values of the groups Pain assesed by Wong-Baker FACES
Time frame: Pain levels of the children will be evaluated 1 minute after the procedure.
The Wong-Baker Faces Pain Scale revised (W-BFS) is used to determine the level of pain during the procedure. The W-BFS is a scale that is most commonly used in identifying pain in children of the ages 3 to 18. It is reported that the scale is reliable when used with children older than the age of 3 who can verbally express the degree of pain they feel. The scale is made up of faces and numbers. Pain is assessed on a scale of "0" to "10." Pain is described by selecting the facial expression depicting the degree of perceived pain. This scale will be assessed independently by the child, a parent who is present and observes the child's behavior, and the same nurse who is independent of the study.
Comparison of the fear score values of the groups
Time frame: Children's fear levels will be evaluated first 1 minutes before the procedure.
The Children's Fear Scale (CFS) is used to measure the child's fear level. This scale is a one-item self-report measure for measuring pain-related fear in children. The CFS is a scale from 0 to 4, showing 5 facial expressions ranging from a neutral expression (0 = no anxiety) to a frightened face (4=severe anxiety). CFS is administered by the researcher to the children to assess their fear levels before and after the IM procedure.
Comparison of the fear score values of the groups
Time frame: Children's fear levels will be evaluated 1 minutes after the procedure.
The Children's Fear Scale (CFS) is used to measure the child's fear level. This scale is a one-item self-report measure for measuring pain-related fear in children. The CFS is a scale from 0 to 4, showing 5 facial expressions ranging from a neutral expression (0 = no anxiety) to a frightened face (4=severe anxiety). CFS is administered by the researcher to the children to assess their fear levels before and after the IM procedure.
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 29 May 2026.
- Results publication: PubMed 21806301McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
- Results publication: PubMed 29559294Gerceker GO, Binay S, Bilsin E, Kahraman A, Yilmaz HB. Effects of Virtual Reality and External Cold and Vibration on Pain in 7- to 12-Year-Old Children During Phlebotomy: A Randomized Controlled Trial. J Perianesth Nurs. 2018 Dec;33(6):981-989. doi: 10.1016/j.jopan.2017.12.010. Epub 2018 Mar 17.
- Results publication: PubMed 31889358Ozalp Gerceker G, Ayar D, Ozdemir EZ, Bektas M. Effects of virtual reality on pain, fear and anxiety during blood draw in children aged 5-12 years old: A randomised controlled study. J Clin Nurs. 2020 Apr;29(7-8):1151-1161. doi: 10.1111/jocn.15173. Epub 2020 Jan 22.
- Results publication: PubMed 31477677Sivri Bilgen B, Balci S. The Effect on Pain of Buzzy(R) and ShotBlocker(R) during the Administration of Intramuscular Injections to Children: A Randomized Controlled Trial. J Korean Acad Nurs. 2019 Aug;49(4):486-494. doi: 10.4040/jkan.2019.49.4.486.
- Results publication: PubMed 25555856Sunitha Suresh BS, De Oliveira GS Jr, Suresh S. The effect of audio therapy to treat postoperative pain in children undergoing major surgery: a randomized controlled trial. Pediatr Surg Int. 2015 Feb;31(2):197-201. doi: 10.1007/s00383-014-3649-9. Epub 2015 Jan 3.
- 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.
Duygu Demir, Assis. Prof. study director
Director
Derya Kılıç, Assis. Prof. principal investigator
Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audio Book Group and Local Vibration Group in people with Procedural Pain, run by University of Yalova 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 11 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 29 May 2026. 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?
Comparison of the pain score values of the groups Pain assesed by Wong-Baker FACES (time frame: Pain levels of the children will be evaluated 1 minute after the procedure.). The study lists 3 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 NCT06354608, which also lists 5 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 29 May 2026.