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Breathwork Training Reduces Anxiety In Outpatient Gastrointestinal Procedures

9. juni 2026 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Florida
      • Jupiter, Florida, Forente stater, 33458
        • Jupiter Medical Center Outpatient Surgical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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.
Atferdsmessig: 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.
Ingen inngripen: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Physiologic parameters of blood pressure
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Length of Stay in postprocedure recovery room
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Calm and Sense Technologies LLC

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

19. mai 2025

Primær fullføring (Faktiske)

30. mai 2025

Studiet fullført (Faktiske)

1. juni 2025

Datoer for studieregistrering

Først innsendt

24. mai 2026

Først innsendt som oppfylte QC-kriteriene

9. juni 2026

Først lagt ut (Faktiske)

15. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Sterling IRB (ID #13491)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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

Tilgangskriterier for IPD-deling

Interested parties that have read the published study

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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