- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07647341
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
Aperçu de l'étude
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Florida
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Jupiter, Florida, États-Unis, 33458
- Jupiter Medical Center Outpatient Surgical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 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.
|
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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Aucune 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
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Physiologic parameters of blood pressure
Délai: 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.
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7 minutes
|
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1. Physiologic parameters of heart rate
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Length of Stay in postprocedure recovery room
Délai: 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.
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From peri-procedure (recovery room admission through discharge home up to 120 minutes)
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Thomas Hernandez, MD, Jupiter Medical Center Outpatient Surgical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Sterling IRB (ID #13491)
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
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