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
Studie Overzicht
Gedetailleerde beschrijving
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
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Florida
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Jupiter, Florida, Verenigde Staten, 33458
- Jupiter Medical Center Outpatient Surgical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: 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.
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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.
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Geen tussenkomst: 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
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Physiologic parameters of blood pressure
Tijdsspanne: 7 minutes
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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.
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7 minutes
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1. Physiologic parameters of heart rate
Tijdsspanne: 7 minutes
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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.
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7 minutes
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Physiologic parameter of respiratory rate
Tijdsspanne: 7 minutes
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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.
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7 minutes
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Length of Stay in postprocedure recovery room
Tijdsspanne: From peri-procedure (recovery room admission through discharge home up to 120 minutes)
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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.
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From peri-procedure (recovery room admission through discharge home up to 120 minutes)
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Thomas Hernandez, MD, Jupiter Medical Center Outpatient Surgical Center
Studie record data
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Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Laatste update ingediend die voldeed aan QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Sterling IRB (ID #13491)
Plan Individuele Deelnemersgegevens (IPD)
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Beschrijving IPD-plan
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IPD-toegangscriteria voor delen
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
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