Anxiety
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALpaced 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.
Sponsors
Calm and Sense Technologies LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physiologic parameters of blood pressure | 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. |
| 1. Physiologic parameters of heart rate | 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. |
| Physiologic parameter of respiratory rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay in postprocedure recovery room | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORThomas Hernandez, MD
Jupiter Medical Center Outpatient Surgical Center
Outcome results
None listed