About this trial
Postoperative complications after surgical procedures, including following total knee arthroplasty (TKA), have a negative impact on the health and well-being of surgical patients. Older adults (≥65 years) are particularly vulnerable to postoperative complications and their associated morbidities due to the biological aging process. Older adults comprise nearly half of surgical patients worldwide, and this number is expected to increase in the next 10-20 years as the aging population continues to grow. TKA is the most common procedure undergone by older adults, and the rate of TKA procedures is also expected to rise. Despite perioperative guidelines and protocols to prevent postoperative complications, the prevalence of postoperative complications following TKA is approximately 12%. Given these statistics, millions of older adults undergoing TKA may be at risk for postoperative complications and their associated morbidities in the coming decades. Therefore, additional interventions are needed to combat postoperative complications in this population.
The body's natural response to surgery, also known as the surgical stress response (SSR), contributes to postoperative complications through complex mechanisms involving the autonomic nervous system (ANS). Increased sympathetic nervous system (SNS) activity, or the body's fight-or-flight response, causes dysregulation in feedback systems that regulate the stress response, potentially leading to poorer outcomes. Interventions, such as breathwork, that induce the parasympathetic nervous system (PNS), or the body's rest-and-digest response, have been shown to balance the ANS, regulate stress biology, and improve outcomes. This study will examine the feasibility of adding a breathwork intervention (Box Breathing), compared to an attention control, to standard perioperative care for older adults undergoing TKA. This study will also examine the proof of concept that Box Breathing, compared to an attention control, may help regulate the SSR by assessing an objective measure of stress-related biology, diurnal cortisol rhythm, and gathering self-report information on pain, anxiety, depression, and quality of recovery following TKA.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
scheduled for elective TKA within the next week to two months (can be second knee, but cannot be a revision of the original knee)
self-reported good health, including denial of debilitating illness that may affect participation in or be potentially exacerbated by deep, controlled breathing (i.e., chronic obstructive pulmonary disorder [COPD], symptomatic or advanced heart failure, complete heart block, glaucoma, epilepsy)
denial of conditions that alter cortisol release or that require corticosteroid therapy (i.e., Cushing's syndrome, Addison's disease, pituitary tumors, adrenal gland tumors, asthma)
denial of severe psychiatric or cognitive conditions that warrant the need for a durable power of attorney (DPOA)
Disqualifiers
currently taking oral, injectable, intranasal, topical, or inhaled corticosteroid medications (i.e., prednisone, hydrocortisone, dexamethasone, methylprednisolone, methylprednisolone acetate, triamcinolone, betamethasone, mometasone, fluticasone, budesonide, clobetasol)
do not have the technology requirements to complete data collection (i.e., participant does not have a smartphone, tablet, laptop, or desktop computer; lack of reliable internet)
Trial design
Parallel
Treatments tested in this trial
A 5-minute Asynchronous Breathwork Intervention
BehavioralParticipants will be guided through the Box Breathing intervention with a pre-recorded YouTube video created by the PI. The video will be embedded into REDCap and delivered online asynchronously to provide flexibility and will be the same for all six sessions. The video will consist of a simple box pattern displayed on the screen with movement around the box that coincides with the PI's voiceover recording of the Box Breathing sequence. . Each session will be five minutes in length, with each section (e.g., inhalation, exhalation, breath retention) of the exercise lasting approximately four seconds. The sequence of each Box Breathing session is performed by breathing through the nose as follows: inhale for 4 seconds, hold the inhalation (lungs "full") for 4 seconds, exhale for 4 seconds, hold the exhalation (lungs "empty") for 4 seconds, and then return to inhaling for 4 seconds. Participants will be encouraged to exhale through the mouth if exhaling through the nose is not accessible.
A 5-minute Asynchronous Card Game Video
BehavioralParticipants will watch the TriPeaks video, a pre-recorded YouTube video created by the PI. The video will be embedded into REDCap and delivered online asynchronously to provide flexibility and will be the same for all six sessions. The video will consist of a screen recording of the PI playing the card game TriPeaks. Each session will be five minutes in length to match the Box Breathing intervention dosage and delivery.
Treatment groups
Trial outcomes
Primary outcomes
Study Feasibility via Recruitment
Enroll a nationwide sample of N=32 older adults (≥65 years of age) scheduled for elective Total Knee Arthroplasty that meet eligibility criteria within the rolling three- to six-month recruitment campaign period
Study Feasibility via Retention
Overall study attrition is ≤25%, with no more than 10% differential attrition between the experimental and control groups, calculated by dividing the number of participants who drop out by total participants enrolled in the study.
Study Feasibility via Receipt of Saliva Samples
Study team receipt of 80% of salivary cortisol samples collected.
Study Feasibility via Postoperative Morbidity Survey Completion
Collection of 80% of postoperative morbidity surveys (Numeric Rating Scale, 11-point; State Anxiety Inventory; Patient-Reported Outcomes Measurement Information System Depression - Short Form 4a; and Quality of Recovery, Short Form)
Secondary outcomes
Postoperative Pain as Assessed by the Numeric Rating Scale (NRS), 11-point
A 1-item, unidimensional 11-point scale (ranging from 0 to 10) used to measure pain intensity at the moment of completing the scale. The higher the score, the more pain the person is experiencing (the higher the score, the worse the outcome).
Postoperative Anxiety as Assessed by the State Anxiety Inventory (SAI)
A 20-item, Likert-type survey used to measure state anxiety (how anxious a person feels in that moment). Reversed scoring is used for 10 of the items that do not exhibit anxiety. The score range is 20 to 80. The higher the score, the greater the state anxiety (the higher the score, the worse the outcome).
Postoperative Depression as Assessed by the Patient-Reported Outcomes Measurement Information System Depression - Short Form 4a (PROMIS-Depression-4a)
A 4-item, Likert-type survey used to measure the severity of depression. The score range is 4 to 20, where higher scores indicate increased depression (the higher the score, the worse the outcome). For this study, survey has been modified from the recall timeline of "last 7 days" to the recall timeline of "last 2 days" to capture symptoms postoperatively.
Quality of Recovery as Assessed by the Quality of Recovery, Short Form (QoR-15)
A 15-item (short-form version of the QoR-40) Likert-type survey used to measure quality of postoperative recovery. Reversed scoring is used for items 11-15. The score range is 0 to 150, with higher scores indicating higher quality of recovery (the higher the score, the better the outcome).
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