Breathwork Training Reduces Anxiety In Outpatient Gastrointestinal Procedures

Pre-procedural Breath Training Reduces Anxiety and Physiologic Stress in Outpatient Gastrointestinal Procedures: A Controlled Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: paced breathwork

Detailed Description

Preoperative anxiety is a well-documented phenomenon that affects up to 80% of surgical patients and is particularly prevalent in outpatient procedures, where patients have limited time to acclimate to the medical environment. This heightened anxiety can lead to increased sympathetic nervous system activation, which elevates heart rate (HR), blood pressure (BP), and respiratory rate (RR), potentially complicating anesthesia induction and recovery.

Pharmaceutical agents such as benzodiazepines and opioids are commonly used to mitigate this anxiety. However, these medications are associated with side effects such as respiratory depression, delayed recovery, and increased cost. Non-pharmacologic interventions, including guided imagery, music therapy, and breathwork, have been investigated as adjunctive therapies for anxiety reduction with varying degrees of success.

Breathwork, particularly slow-paced breathing at a rate of six breaths per minute, has been shown to increase parasympathetic activity, improve autonomic balance and reduce physiologic stress markers. This study evaluates a structured, multisensory breath training intervention designed to facilitate paced breathing in patients undergoing outpatient gastrointestinal procedures.

In this prospective controlled study, 30 patients undergoing outpatient gastrointestinal (GI) procedures received a seven-minute pre-procedural breath training intervention and were compared to 30 matched retrospective controls. Physiologic parameters including heart rate (HR), blood pressure (BP), and respiratory rate (RR) were measured pre- and post-intervention. Recovery time was also assessed.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jupiter, Florida, United States, 33458
      • Jupiter Medical Center Outpatient Surgical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: paced breathwork; 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay in postprocedure recovery room	The recovery room duration is defined as the exact time elapsed (in minutes) from the moment the patient enters the recovery room post-procedure until the formal medical discharge criteria are met and the patient is released home. The metric reported represents the mean difference in recovery time between the prospective intervention group and the 30 randomized retrospective control patients.	From peri-procedure (recovery room admission through discharge home up to 120 minutes)

Collaborators and Investigators

• Sponsor: Calm and Sense Technologies LLC
• Investigators: Principal Investigator: Thomas Hernandez, MD, Jupiter Medical Center Outpatient Surgical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2025
• Primary Completion (Actual): May 30, 2025
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: May 24, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: Sterling IRB (ID #13491)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The physiologic data and recovery room data can be shared. This data was analyzed by an accredited statistician and results will be published
• IPD Sharing Time Frame: The data will be shared in the publication. If an interested party wishes further information, this can be shared as well
• IPD Sharing Access Criteria: Interested parties that have read the published study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No