Trial Outcomes & Findings for Postoperative Telehealth Mindfulness Intervention After Spine Surgery (NCT NCT04648683)

Postoperative Telehealth Mindfulness Intervention After Spine Surgery

Percentage of participants enrolled who complete the study

Percent of sessions attended out of 8

Nine items assessing satisfaction with the postsurgical telehealth mindfulness intervention (sum of item scores; higher scores indicate higher satisfaction; scores can range from 7 to 55)

One item assessing how bothersome pain has been in the past 7 days from not at all = 0 to extremely = 4. A higher scores indicates higher pain bothersomeness.

Pain Interference short-form 4a from the Patient Reported Outcomes Measurement Information System scale. Measures interference of pain in day to day activities, work around the home, participation in social activities, and household chores over the past 7 days. Raw scores are converted to T-scores with a population mean of 50 and standard deviation of 10. A lower T-score indicates lower pain interference, or a better outcome.

1 item from the Patient Reported Outcomes Measurement Information System (PROMIS), with average pain intensity over the past 7 days rated on 0-10 scale with lower values indicating less pain, or better outcome.

2 items assessing back and leg pain intensity on a scale of 0-10 over the past 7 days, described as pain when off medication or medication has worn off. Lower scores indicate less pain, or better outcome.

Measured as average number of opioid pills per day (name and dose specified) and converted to morphine equivalent dose.

Anxiety short-form 4a - Patient Reported Outcomes Measurement Information System. 4 items assessing anxiety symptoms in the past 7 days (e.g. "I felt fearful"). Raw scores are converted to T-scores with a population mean of 50 and standard deviation of 10. Lower scores represent lower anxiety, a better outcome.

Depression short-form 4a - Patient Reported Outcomes Measurement Information System scale. 4 items assessing depressive symptoms over the past 7 days (e.g. "I felt worthless). Raw scores are converted to T-scores with a population mean of 50 and standard deviation of 10. A lower score indicates less depression, a better outcome.

Assesses impact of pain on level of functioning in 10 areas (e.g. walking, sleep, social life). Scores range from 0-100. Lower scores indicate lower level of disability due to pain, a better outcome.

13 items assessing thoughts and feelings when in pain (e.g. "I become afraid that the pain will get worse." Scores range from 0-52. Lower scores indicate lower pain catastrophizing, a better outcome.

10 items assessing confidence in ability to do certain things despite pain (e.g. "I can enjoy things, despite the pain." Scores range from 0 to 60. Higher scores indicate greater pain self-efficacy, a better outcome.

4 items assessing perceived level of stress in the past month (e.g. "In the last month, how often have you felt that you were unable to control the important things in your life?"). Scores range from 0-16. Lower scores indicate lower perceived stress, a better outcome.

13 items assessing fear of movement (e.g. "I'm afraid that I might injure myself if I exercise." Scores range from 13-52. Lower scores indicate lower levels of kinesiophobia, a better outcome.

15 items assessing 5 facets of mindfulness, including observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Scores range from 1 to 5 (calculated by taking the average of the total sum score). Higher scores indicate higher levels of mindfulness, a better outcome.