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Active, Not Recruiting

NCT Number: NCT06234228

Examining Bluetooth Haptic Device Use for Pain and Anxiety Reduction in Vascular Access Procedures

This pragmatic, randomized study seeks to evaluate the applications of a novel vibrating device for reducing pediatric anxiety and distress during vascular access procedures.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pain Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucile Packard Childrens Hospital Stanford

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between age 4-99
  • Will undergo a vascular access procedure
  • English speaking participant and parent or LAR

Exclusion criteria

  • 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

Treatment and study plan

Bluetooth Haptic Device (BHD)

Behavioral

The BHD will deliver constant low-frequency vibration (CF).

BHD synced with mobile game

Behavioral

The BHD delivers a constant low-frequency vibration as well as tactile feedback from the game (GF).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Faces Pain Scale-Revised for patients aged 4-11

    Time frame: during vascular access procedure

    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.

  2. Numerical Rating Pain Scale (NRPS) for patients aged 12-17

    Time frame: during vascular access procedure

    NRPS is a 11-point (0-10) Numeric Rating Pain Scale (NRPS), where 0 = no pain and 10 = worst possible pain.

  3. modified induction compliance checklist (mICC)

    Time frame: during vascular access procedure

    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.

  4. External observation for pain and anxiety using HRAD scale

    Time frame: during vascular access procedure

    HRAD contains 5-item scale assessing participant's affective state; happy, relaxed, anxious, distressed, with a yes/no answer to cooperation.

  5. Children's Anxiety Meter-State (CAM-S) assessment

    Time frame: immediately before, immediately after vascular access procedure

    The CAM-S is completed by showing the child a picture of a mercury thermometer. This scale is measured from 1-10. Higher values indicate higher anxiety.

  6. Self formulated procedural satisfaction survey (Patient and Parent)

    Time frame: immediately after vascular access procedure

    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."

  7. Self formulated procedural satisfaction survey (Healthcare provider)

    Time frame: immediately after vascular access procedure

    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."

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Acronym: VA+BHD

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 31, 2024
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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