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Table 2 Timeline of study assessments and measures

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

Timepoint

Baseline

Pre-intervention

Post-intervention

Follow-ups

Variable, category, or measure

Screening

Visit 1

Visit 2

Visit 3

1 months

2 months

3 months

 Demographic information

X

X

     

 Contact information

X

      

 Eligibility criteria

X

X

     

 Health history

X

X

     

 Pain history [119]

X

X

     

 NIH PROMIS Positive Affect and Well-being [133]

 

X

     

 Stress and Adversity Inventorya [134]

 

X

     

Feasibility and acceptability

 Treatment acceptability

   

X

   

 Treatment expectations [135]

  

X

    

 Blinding effectiveness

   

X

   

 Adverse events

  

X

X

   

Secondary outcomes and process measures

 NIH PROMIS-Short forms (pain intensity, pain interference, depression, sleep disturbance, sleep-related impairment) [133, 136–138]

 

X

 

X

X

X

X

 Brief Pain Inventory-Short form [139, 140]

 

X

 

X

X

X

X

 Michigan Body Map [141, 142]

 

X

     

 Patients’ Global Impression of Change [143–145]

   

X

X

X

X

 Oswestry Disability Index [146]

 

X

 

X

X

 

X

 Pain Catastrophizing Scale [147]

 

X

 

X

X

 

X

 Pain Self-Efficacy Questionnaire [148]

 

X

 

X

X

 

X

 Perceived Stress Scale [149]

 

X

 

X

X

X

X

 Generalized Anxiety Disorder 2-item [150]

 

X

 

X

X

X

X

 Multidimensional Assessment of Interoceptive Awareness-2 [151]

 

X

 

X

X

 

X

 Multidimensional Psychological Flexibility Inventorya [152, 153]

 

X

 

X

X

 

X

Physical and physiological assessments

 Back performance scale [154]

 

X

 

 X

   

 Short performance physical battery [155]

 

X

 

 X

   

 Quantitative sensory testing [156, 157]

  

X

X

   

 Heart rate variability

  

X

X

   

 Oxygen saturation

  

X

X

   

Blood pressure

 

X

X

X

   
  1. aAssessment will be completed online between Visit 1 and Visit 2
  2. NIH National Institutes of Health, PROMIS Patient-Reported Outcomes Measurement Information System