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OpenTrials
Completed

NCT Number: NCT07647341

Breathwork Training Reduces Anxiety In Outpatient Gastrointestinal Procedures

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jupiter Medical Center Outpatient Surgical Center

Jupiter, Florida, 33458, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

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.

Primary outcomes

  1. Physiologic parameters of blood pressure

    Time frame: 7 minutes

    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.

  2. 1. Physiologic parameters of heart rate

    Time frame: 7 minutes

    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.

  3. Physiologic parameter of respiratory rate

    Time frame: 7 minutes

    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.

Secondary outcomes

  1. Length of Stay in postprocedure recovery room

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

    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.

Sponsors and collaborators

Lead sponsor

Calm and Sense Technologies LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 15, 2026
Registry last updated
Jun 15, 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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