Breathwork Training Reduces Anxiety In Outpatient Gastrointestinal Procedures

NCT07647341 | Completed

• 1 other identifier: Sterling IRB (ID #13491)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (3)

• Physiologic parameters of blood pressure

  Evaluated via standard automated clinical monitors. The metric reported is the mean change in blood pressure (in mmhg), from the pre-training baseline to the post-training 7-minute mark.

  7 minutes

• 1. Physiologic parameters of heart rate

  Evaluated via standard automated clinical monitors. The metric reported is the mean change in heart rate in beats per minute, from the pre-training baseline to the post-training 7-minute mark.

  7 minutes

• Physiologic parameter of respiratory rate

  Evaluated via standard automated clinical monitors. The metric reported is the mean change in respiratory rate in breaths per minute, from the pre-training baseline to the post-training 7-minute mark.

  7 minutes

Secondary Outcomes (1)

• Length of Stay in postprocedure recovery room

  From peri-procedure (recovery room admission through discharge home up to 120 minutes)

Study Arms (2)

Arm 1- 30 sequential GI procedure outpatients

ACTIVE COMPARATOR

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.

Behavioral: paced breathwork

retrospective chart review of 30 recent patients comparing recovery room times- no intervention

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

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.

Arm 1- 30 sequential GI procedure outpatients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• consecutive patients
• aged 18-85
• undergoing outpatient GI procedure (colonoscopy, upper GI endoscopy)
• under monitered anesthesia care

You may not qualify if:

• pregnancy
• pacemaker
• anti-arhythmic medications
• severe acute illness
• sensitivity or previous problems with general anesthesia
• fragrance sensitivity

Sponsors & Collaborators

• Calm and Sense Technologies LLC: lead

Study Sites (1)

Jupiter Medical Center Outpatient Surgical Center

Jupiter, Florida, 33458, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Thomas Hernandez, MD

  Jupiter Medical Center Outpatient Surgical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 15, 2026
• Study Start: May 19, 2025
• Primary Completion: May 30, 2025
• Study Completion: June 1, 2025
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be shared in the publication. If an interested party wishes further information, this can be shared as well
• Access Criteria: Interested parties that have read the published study

Locations

US (1)