Breathwork Training Reduces Anxiety In Outpatient Gastrointestinal Procedures

Part of paid clinical trials in Jupiter, Florida.

Sponsor
Calm and Sense Technologies LLC
Study ID
NCT07647341
Status
Completed

Conditions

  • Anxiety

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • paced breathwork — BEHAVIORAL
    The intervention is a noninvasive vibratory breathwork strategy, paced to 6 times per minute, and utilized for 7 minutes, in the preprocedure holding room. This is meant to cue the patient to breath more slowly and calm the patient down before the procedure without pharmaceutical intervention.

Study Details

Preoperative anxiety is common in outpatient procedures and can negatively impact physiologic stability and recovery. Non-pharmacologic interventions may offer a safe alternative to traditional anxiolytics. This study utilizes a 7 minute noninvasive paced breathwork strategy that cues patients to slow their breathing to 6 times per minute. Physiologic parameters, such as blood pressure, heart rate, and respiratory rate will be compared pre and and post intervention, as well as recovery room time.

Key Dates

Start date
May 19, 2025
Status verified
Jun 2026
Primary completion
May 30, 2025
Completion
Jun 1, 2025

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Active Comparator: Arm 1- 30 sequential GI procedure outpatients
    this arm receives the noninvasive, paced breathwork device breathwork intervention for 7 minutes and physiogic data is charted by the nursing staff before and after the intervention. The patient therefore acts as their own control.
  • No Intervention: retrospective chart review of 30 recent patients comparing recovery room times- no intervention
    this arm did not have an intervention- therefore there is only one set of vitals in the chart. this arm utilized 30 sequential patients for chart review of recovery room times only

Primary Outcome Measure

Physiologic parameters of blood pressure [ Time Frame: 7 minutes ]

Locations (1)

FacilityCityStateZIPSite coordinators
Jupiter Medical Center Outpatient Surgical CenterJupiterFlorida33458-

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Jupiter Medical Center Outpatient Surgical Center· Jupiter, FL

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