Conscious connected breathing with breath retention intervention in adults with chronic low back pain: protocol for a randomized controlled pilot study

This study is a *protocol*, meaning it describes the plan for a research study that has not yet been completed or published its results. Therefore, it outlines what *will be* tested, not what *was* found.

The researchers plan to test a specific breathing intervention against a control condition in adults experiencing chronic low back pain (cLBP).

**Intervention:** Conscious connected breathing with breath retention. This technique involves breathing without pauses between inhale and exhale, followed by periods of holding the breath. The specific duration and intensity of the practice are not detailed in the abstract, but the intervention will be delivered via standardized audio recordings.

**Comparator:** A deep breathing sham control intervention. This is a "sham" control because it involves a breathing practice that is expected to have less specific therapeutic effect than the active intervention, but still provides an activity for participants to engage in, helping to control for the placebo effect (the benefit derived simply from receiving an intervention or attention). This intervention will also be delivered via standardized audio recordings.

**Primary Outcomes (Feasibility and Acceptability):**

* **Feasibility:** How practical it is to run the study and for participants to engage with the intervention. This will be measured by tracking:

* Participant recruitment rates (how easily people can be found and enrolled).

* Adherence rates (how consistently participants follow the intervention instructions).

* Retention rates (how many participants complete the study).

* Study assessment completion rates (how many participants complete all questionnaires and measurements).

* **Acceptability:** How well participants receive and respond to the intervention. This will be measured by assessing:

* Participants' satisfaction with the intervention.

* Participants' perception of the helpfulness of the intervention.

**Secondary/Exploratory Outcomes (for a future, larger study):** The researchers will also collect data on various other factors that could be influenced by the breathing practice, to inform a larger follow-up study. These include:

* Clinical pain variables (e.g., pain intensity, pain interference with daily life).

* Psychological variables (e.g., mood, stress, anxiety, depression).

* Behavioral variables (e.g., physical activity levels, sleep quality).

* Physiological variables (e.g., heart rate variability, breathing rate, blood pressure).

The abstract does not specify the exact instruments or scales that will be used to measure these secondary outcomes.

The study plans to enroll a small group of participants:

**Sample Size:** 24 adults. This is a very small sample, typical for a pilot study designed to test feasibility rather than the effectiveness of an intervention.

**Population:** Adults aged 18 to 65 years old who have chronic low back pain (cLBP). Chronic low back pain is generally defined as pain lasting for 3 months or longer. The abstract does not specify other inclusion or exclusion criteria (e.g., specific pain intensity levels, co-morbid conditions, medication use), which would typically be detailed in a full protocol.

**Setting:** The interventions will involve a hybrid approach: two practice sessions will be conducted in-person, likely at a research facility, and three practice sessions will be completed at home by the participants. This design aims to mimic a real-world self-management approach.

Since this is a protocol, the abstract describes *how they plan to measure* outcomes.

**Feasibility:** This will be measured quantitatively by tracking specific rates:

* **Recruitment Rate:** The number of eligible participants enrolled over a specific period.

* **Adherence Rate:** The percentage of prescribed breathing sessions that participants actually complete. This will likely be tracked through self-report (e.g., a logbook) for at-home sessions and direct observation for in-person sessions.

* **Retention Rate:** The percentage of participants who complete the entire 5-day study and all follow-up assessments.

* **Assessment Completion Rate:** The percentage of questionnaires and measurements that participants successfully complete.

**Acceptability:** This will be measured through participants' subjective feedback:

* **Satisfaction:** Likely assessed using questionnaires with rating scales (e.g., "How satisfied were you with the breathing practice?" on a scale of 1-5).

* **Helpfulness:** Also likely assessed using questionnaires (e.g., "How helpful did you find the breathing practice for your pain or well-being?" on a scale of 1-5).

**Clinical Pain, Psychological, Behavioral, and Physiological Variables:** The abstract states these will be measured to inform a future larger trial, but it *does not specify the instruments or scales* that will be used for these outcomes. In a full protocol, this section would detail specific questionnaires like the Numeric Rating Scale (NRS) for pain intensity, Oswestry Disability Index (ODI) for pain-related disability, Patient Health Questionnaire (PHQ-9) for depression, Generalized Anxiety Disorder (GAD-7) for anxiety, Pittsburgh Sleep Quality Index (PSQI) for sleep, or physiological measurements like heart rate variability (HRV) using a monitor. The absence of these details in the abstract means we cannot be specific about *how* these will be measured in this pilot study.

This study is designed as a **randomized controlled pilot study**. This specific design choice is critical for understanding what the study can and cannot achieve.

**Study Design:**

* **Randomized:** Participants will be randomly assigned to either the active conscious connected breathing group or the deep breathing sham control group. Randomization is a cornerstone of robust research because it helps ensure that, on average, the two groups are similar in all characteristics (known and unknown) at the start of the study. This minimizes the risk that any observed differences between the groups are due to pre-existing differences rather than the intervention itself.

* **Controlled:** The inclusion of a sham control group is essential. Without a control group, it would be impossible to tell if any improvements observed were due to the specific breathing technique, the general attention participants received, the natural fluctuation of chronic pain, or simply the expectation of benefit (placebo effect). The sham control helps isolate the specific effects of the conscious connected breathing.

* **Pilot Study:** This designation is crucial. A pilot study is a small-scale preliminary study conducted to evaluate the feasibility, time, cost, adverse events, and variability in an attempt to predict an appropriate sample size and improve upon the study design prior to performance of a full-scale research project. It is *not* designed to definitively prove the efficacy or effectiveness of an intervention.

**Randomisation:** The abstract states participants will be randomized, but it does not specify the method of randomization (e.g., simple randomization, block randomization, stratified randomization). For a small study like this, simple randomization (like a coin flip or computer-generated random numbers) is common. The purpose, as noted, is to create comparable groups.

**Blinding:** The study attempts a form of blinding for the participants. Both the active conscious connected breathing and the sham deep breathing interventions are described to participants as "Breathing and Attention Training." This is done to reduce "expectancy and placebo effects common in pain research." By giving both interventions a similar, neutral label, the researchers aim to prevent participants from guessing which group they are in and thus influencing their self-reported outcomes based on their expectations. However, it's important to note that participants might still be able to distinguish between the two breathing techniques once they start practicing, potentially compromising this blinding.