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Breathwork Training Reduces Anxiety In Outpatient Gastrointestinal Procedures

9 juni 2026 uppdaterad av: Calm and Sense Technologies LLC

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

30

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Florida
      • Jupiter, Florida, Förenta staterna, 33458
        • Jupiter Medical Center Outpatient Surgical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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.
Beteende: 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.
Inget ingripande: 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Physiologic parameters of blood pressure
Tidsram: 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.
7 minutes
1. Physiologic parameters of heart rate
Tidsram: 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.
7 minutes
Physiologic parameter of respiratory rate
Tidsram: 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.
7 minutes

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Length of Stay in postprocedure recovery room
Tidsram: 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.
From peri-procedure (recovery room admission through discharge home up to 120 minutes)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Calm and Sense Technologies LLC

Utredare

  • Huvudutredare: Thomas Hernandez, MD, Jupiter Medical Center Outpatient Surgical Center

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

19 maj 2025

Primärt slutförande (Faktisk)

30 maj 2025

Avslutad studie (Faktisk)

1 juni 2025

Studieregistreringsdatum

Först inskickad

24 maj 2026

Först inskickad som uppfyllde QC-kriterierna

9 juni 2026

Första postat (Faktisk)

15 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

15 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • Sterling IRB (ID #13491)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

The physiologic data and recovery room data can be shared. This data was analyzed by an accredited statistician and results will be published

Tidsram för IPD-delning

The data will be shared in the publication. If an interested party wishes further information, this can be shared as well

Kriterier för IPD Sharing Access

Interested parties that have read the published study

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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