Recruiting

Box Breathing

Sponsor:

University of Arizona

Code:

NCT07464860

Conditions

Surgical Stress Response

Stress Physiological

Stress Physiology

Stress Psychological

Breathing Techniques

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

A 5-minute Asynchronous Breathwork Intervention

A 5-minute Asynchronous Card Game Video

Study Details

Brief summary:

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.

Conditions

Surgical Stress Response

Stress Physiological

Stress Physiology

Stress Psychological

Breathing Techniques

Study ID

NCT07464860

Start date

Jul 1, 2026

Status verified date

Jul, 2026

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Oct 6, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Adults aged 65 years or older of any sex, gender and ethnic background who meet the following criteria will be eligible to enroll in the present study:

Inclusion Criteria:

  • 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)
  • able to understand written and verbal English.

Exclusion Criteria:

  • 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)

The following exclusion criteria may affect participants' ability to remain in the study following enrollment:

• Development of complications during surgery that require prolonged hospitalization into Postoperative Day (POD) 2 (e.g., postoperative intubation and ventilation requirements, intractable pain, intractable nausea/vomiting, signs of infection or sepsis)

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Experimental Group - Box Breathing Intervention

Participants in this group will complete a 5-minute virtual Box Breathing session three times a day for two consecutive days following surgery on Postoperative Day 2 and 3. The Box Breathing intervention will be delivered asynchronously via a YouTube video created by the PI and accessed by participants via REDCap. Participants will also collect saliva samples three times per day (upon waking, 30 minutes after waking, and at bedtime) on Postoperative Day 2 and 3 to measure diurnal cortisol rhythm. Participants will fill out a 1-item survey about the Box Breathing session and a 1-item survey about saliva sample collection after each session and collection timepoint. Participants will also complete seven additional surveys regarding pain, anxiety, depression, and quality of recovery on the evening of Postoperative Day 3 after the final Box Breathing session.

active comparator: Attention Control Group - TriPeaks Video

Participants in this group will complete a 5-minute virtual TriPeaks Video session three times a day for two consecutive days following surgery on Postoperative Day 2 and 3. The TriPeaks Video will be delivered asynchronously via a YouTube video created by the PI and accessed by participants via REDCap. Participants will also collect saliva samples three times per day (upon waking, 30 minutes after waking, and at bedtime) on Postoperative Day 2 and 3 to measure diurnal cortisol rhythm. Participants will fill out a 1-item survey about the TriPeaks Video session and a 1-item survey about saliva sample collection after each session and collection timepoint. Participants will also complete seven additional surveys regarding pain, anxiety, depression, and quality of recovery on the evening of Postoperative Day 3 after the final TriPeaks Video session.

Interventions

A 5-minute Asynchronous Breathwork Intervention

Participants 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

Participants 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.

Primary outcome measure

  • Study Feasibility via Recruitment [ Time Frame: Through study completion, an average of 4.5 months ]
  • Study Feasibility via Retention [ Time Frame: Through study completion, an average of 4.5 months ]
  • Study Feasibility via Receipt of Saliva Samples [ Time Frame: Through study completion, an average of 4.5 months ]
  • Study Feasibility via Postoperative Morbidity Survey Completion [ Time Frame: Through study completion, an average of 4.5 months ]
  • Box Breathing Intervention Feasibility via Box Breathing Completion Survey [ Time Frame: Through study completion, an average of 4.5 months ]
  • Box Breathing Intervention Feasibility via Feasibility of Intervention Measure (FIM) [ Time Frame: Measured one time on the evening of Postoperative Day 3 ]
  • Box Breathing Intervention Acceptability via Acceptability of Intervention Measure (AIM) [ Time Frame: Measured one time on the evening of Postoperative Day 3 ]
  • Box Breathing Intervention Appropriateness via Intervention Appropriateness Measure (IAM) [ Time Frame: Measured one time on the evening of Postoperative Day 3 ]
  • TriPeaks Video Attention Control Task Feasibility via Attention Control Task Completion Survey [ Time Frame: Through study completion, an average of 4.5 months ]
  • TriPeaks Video Attention Control Task Feasibility via Feasibility of Intervention Measure (FIM) [ Time Frame: Measured one time on the evening of Postoperative Day 3 ]
  • TriPeaks Video Attention Control Task Acceptability via Acceptability of Intervention Measure (AIM) [ Time Frame: Measured one time on the evening of Postoperative Day 3 ]
  • TriPeaks Video Attention Control Task Appropriateness via Intervention Appropriateness Measure (IAM) [ Time Frame: Measured one time on the evening of Postoperative Day 3 ]

Central Contacts and Locations

Central contacts

Devon E Cobos Garcia, PhD Candidate, MS, BSN

904-477-7960decg0131@arizona.edu

Locations

The University of Arizona

Recruiting

Tucson, Arizona, United States, 85721

Contacts

Devon E Cobos Garcia

904-477-7960decg0131@arizona.edu

More Information

Sponsor

University of Arizona

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • Surgical Stress Response
  • Total Knee Arthroplasty
  • Hypothalamic-Pituitary-Adrenal Axis
  • Breathwork
  • Breathing Exercises
  • Breathing Techniques
  • Postoperative Complications
  • Postoperative Pain
  • Postoperative Anxiety
  • Postoperative Depression
  • Quality of Recovery
  • Diurnal Cortisol Rhythm

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2026-07-06.