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

Pain Clinical Trial

— VA+BHD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06234228
• Other study ID #: 73750
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: Thomas Caruso, MD, PhD
• Phone: 650-723-5728
• Email: tjcaruso[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 25 Years

Eligibility

Inclusion Criteria:

• Between age 7-25

• Will undergo a vascular access procedure

• English speaking participant and parent or LAR

Exclusion Criteria:

• Legal guardian not present to obtain consent

• 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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain

Intervention

Behavioral:
• Bluetooth Haptic Device (BHD)
The BHD will deliver constant low-frequency vibration (CF).
• BHD synced with mobile game
The BHD delivers a constant low-frequency vibration as well as tactile feedback from the game (GF).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Faces Pain Scale-Revised (FPS-R) 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.	during vascular access procedure
Primary	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.	during vascular access procedure
Secondary	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.	during vascular access procedure
Secondary	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.	during vascular access procedure
Secondary	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.	during vascular access procedure
Secondary	Self formulated procedural satisfaction survey	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."	after vascular access procedure