PainVA+BHDNCT06234228
Examining Bluetooth Haptic Device Use for Pain and Distress Reduction in Vascular Access Procedures
A study testing Bluetooth Haptic Device (BHD) and BHD synced with mobile game in people with Pain and Anxiety, run by Stanford University at 1 site in United States.
Trial summary
This pragmatic, randomized study seeks to evaluate the applications of a novel vibrating device for reducing pediatric anxiety and distress during vascular access procedures. Read more about this study
- Who is it for?
- Ages 4 to 99 years
- What is being tested?
- Bluetooth Haptic Device (BHD) and BHD synced with mobile game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2024to 4 Nov 2025
- 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 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Between age 4-99
- Will undergo a vascular access procedure
- English speaking participant and parent or LAR
Who cannot join
- Legal guardian not present to obtain consent
- Child is unable to self-report pain or anxiety
- Child with a significant neurological condition, or major developmental disability
- Child with active infection of the hand or arm
- Major surgery within the last 48 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Childrens Hospital Stanford
Palo Alto, California, 94304
About this study
Official title: Examining Bluetooth Haptic Device Use for Pain and Distress Reduction in Vascular Access Procedures (VA+BHD)
This pragmatic, randomized study seeks to evaluate the applications of a novel vibrating device for reducing pediatric anxiety and distress during vascular access procedures.
- Being tested
- Bluetooth Haptic Device (BHD), BHD synced with mobile game
- Keywords
- Vascular access
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bluetooth Haptic Device (BHD)Behavioural
The BHD will deliver constant low-frequency vibration (CF).
BHD synced with mobile gameBehavioural
The BHD delivers a constant low-frequency vibration as well as tactile feedback from the game (GF).
| Study group | Role | What they receive |
|---|---|---|
| BHD synced with mobile game | Experimental | At the beginning of the vascular access procedure, the BHD will be applied 5 cm above the needle insertion site and maintained in place throughout the procedure. It delivers a constant low-frequency vibration as well as tactile feedback from the game (GF). Receives: Behavioral: BHD synced with mobile game |
| BHD only | Other | The participant will wear the BHD 5 cm above the needle insertion site for the duration of the procedure. The BHD will deliver constant low-frequency vibration (CF). Receives: Behavioral: Bluetooth Haptic Device (BHD) |
| Standard of Care | No intervention | The participant will not receive the BHD device. Participant will receive standard of care treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
External observation for pain and anxiety using OBSD-r scale
OBSD-r contains 8-item scale assessing participant's affective state; Information Seeking, Crying, Screaming, Restraint, Verbal Resistance, Emotional Support, Verbal Pain and Flail.
Measured: during vascular access procedure
Secondary outcomes (6)
modified induction compliance checklist (mICC)
The mICC score will be recorded by the trained research observers during the vascular access procedure. Perfect compliance (score of 0) was compared to those that lacked cooperation. mICC will be rated at the time of intervention and only requires one RA.
Measured: during vascular access procedure
External observation for pain and anxiety using HRAD scale
HRAD contains 5-item scale assessing participant's affective state; happy, relaxed, anxious, distressed, with a yes/no answer to cooperation.
Measured: during vascular access procedure
Faces Pain Scale-Revised for patients aged 4-11
Detailed qualitative review of cognitive interview probes with question-by-question analysis of transcribed cognitive interviews to assess for basic comprehension and appropriate use of the FPS-R. This scale is measured from 0-10, where 0 = no pain and 10 = very much pain.
Measured: during vascular access procedure
Numerical Rating Pain Scale (NRPS) for patients aged 12-17
NRPS is a 11-point (0-10) Numeric Rating Pain Scale (NRPS), where 0 = no pain and 10 = worst possible pain.
Measured: during vascular access procedure
Self formulated procedural satisfaction survey (Healthcare provider)
The survey contains 5 items and utilizes a 5-point Likert agreement scale with a score of 1 meaning "completely disagree" and 5 meaning "completely agree."
Measured: immediately after vascular access procedure
Self formulated procedural satisfaction survey (Patient and Parent)
The survey contains 10 items and utilizes a 5-point Likert agreement scale with a score of 1 meaning "completely disagree" and 5 meaning "completely agree."
Measured: immediately after vascular access procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start25 Jul 2024
- Primary completion4 Nov 2025
- Study completion4 Nov 2025
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 Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Caruso, Stanford University
- Investigators
- Thomas Caruso, MD,PhD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234228
- Sponsor's protocol ID
- 73750
- Acronym
- VA+BHD
- Status last verified
- Oct 2026
- First submitted
- 22 Jan 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Bluetooth Haptic Device Use for Pain and Distress Reduction in Vascular Access Procedures (VA+BHD)
- ClinicalTrials.gov ID
- NCT06234228
- Acronym / sponsor ID
- VA+BHD / 73750
- Keywords
- Vascular access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 4 Nov 2025 (actual)
- Study completion
- 4 Nov 2025 (actual)
- First posted
- 31 Jan 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.
This pragmatic, randomized study seeks to evaluate the applications of a novel vibrating device for reducing pediatric anxiety and distress during vascular access procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BHD synced with mobile game | Experimental | Behavioral: BHD synced with mobile gameAt the beginning of the vascular access procedure, the BHD will be applied 5 cm above the needle insertion site and maintained in place throughout the procedure. It delivers a constant low-frequency vibration as well as tactile feedback from the game (GF). |
| BHD only | Other | Behavioral: Bluetooth Haptic Device (BHD)The participant will wear the BHD 5 cm above the needle insertion site for the duration of the procedure. The BHD will deliver constant low-frequency vibration (CF). |
| Standard of Care | No intervention | –The participant will not receive the BHD device. Participant will receive standard of care treatment. |
Who may qualify
- Ages
- 4 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Between age 4-99
- Will undergo a vascular access procedure
- English speaking participant and parent or LAR
Key exclusion criteria (5 listed)
- Legal guardian not present to obtain consent
- Child is unable to self-report pain or anxiety
- Child with a significant neurological condition, or major developmental disability
- Child with active infection of the hand or arm
- Major surgery within the last 48 hours
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 |
|---|---|---|
| Bluetooth Haptic Device (BHD)The BHD will deliver constant low-frequency vibration (CF). | Behavioural | BHD only |
| BHD synced with mobile gameThe BHD delivers a constant low-frequency vibration as well as tactile feedback from the game (GF). | Behavioural | BHD synced with mobile game |
Primary outcome
External observation for pain and anxiety using OBSD-r scale
Time frame: during vascular access procedure
OBSD-r contains 8-item scale assessing participant's affective state; Information Seeking, Crying, Screaming, Restraint, Verbal Resistance, Emotional Support, Verbal Pain and Flail.
6 secondary outcomes
modified induction compliance checklist (mICC)
Time frame: during vascular access procedure
External observation for pain and anxiety using HRAD scale
Time frame: during vascular access procedure
Faces Pain Scale-Revised for patients aged 4-11
Time frame: during vascular access procedure
Numerical Rating Pain Scale (NRPS) for patients aged 12-17
Time frame: during vascular access procedure
Self formulated procedural satisfaction survey (Healthcare provider)
Time frame: immediately after vascular access procedure
Self formulated procedural satisfaction survey (Patient and Parent)
Time frame: immediately after vascular access 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 8 Oct 2026.
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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.
Thomas Caruso, MD,PhD study director
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bluetooth Haptic Device (BHD) and BHD synced with mobile game in people with Pain and Anxiety, run by Stanford University 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 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 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 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?
External observation for pain and anxiety using OBSD-r scale (time frame: during vascular access procedure). 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 8 Oct 2026.