Postoperative Telehealth Mindfulness Intervention After Spine Surgery

Not Applicable

Completed

Conditions: Lumbar Spine Surgery
Chronic Low-back Pain
Opioid Use
Postsurgical Pain

Interventions: Behavioral: Group telehealth mindfulness
Behavioral: Individual telehealth mindfulness

Registration Number: NCT04648683

Lead Sponsor: Vanderbilt University Medical Center

Brief Summary: Lumbar spine pain is the leading cause of years lived with a disability and affects over 50 million individuals in the United States. Rates of spine surgeries performed to address degenerative spine conditions have increased markedly. A subset of patients experience poor pain, functional, or quality of life outcomes after surgery.

This study will adapt and evaluate the feasibility and potential benefits of both a one-on-one and a group-delivered, face-to-face telehealth, mindfulness intervention for patients recovering from lumbar spine surgery. The goals of the intervention are to improve short and long-term pain management, reduce the need for long-term pain medications, and improve physical and psychological well-being after surgery. The study will result in a refined intervention manual based on feasibility, participant exit interviews and satisfaction surveys which will be piloted in a future randomized controlled trial.

Detailed Description: We will conduct a two-arm, nonrandomized, mixed-methods trial to refine a telehealth mindfulness-based intervention (MBI) for patients recovering from spine surgery. The procedures will be as follows:

1. Recruit, consent and enroll up to 26 patients over a period of 8 months who are planning to have their first lumbar spine surgery for a degenerative spine condition at the Vanderbilt Comprehensive Spine Center. Recruitment will occur at a routine preoperative clinic visit or over the phone, with the spine surgeon's permission to approach the patient.

2. Two weeks after enrolled patients complete surgery, they will meet with an interventionist for eight, weekly one-on-one or group-delivered telehealth MBI sessions over a Zoom online telehealth platform. Sessions will be 75 minutes long (90 minutes for the first session). Sessions will be audio recorded and the interventionists will be supervised weekly.

3. Participants will complete self-report assessments prior to surgery, two weeks after surgery (pre-intervention) and three months after surgery (post-intervention).

4. After completing the intervention, participants will complete an intervention satisfaction survey and an audio-recorded 30-minute semi-structured interview over the phone to provide feedback regarding their experience with the intervention components and relevance to their postoperative recovery.

5. We will code and analyze interview data continuously (every 2-4 interviews) until we reach data saturation and then integrate results from interviews and self-report surveys to determine relevant intervention adaptations, constructing a refined intervention protocol for pilot testing in a randomized controlled trial. We anticipate needing approximately 13-20 participants to complete interviews to reach data saturation (i.e. no new, relevant information obtained from interviews).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Telehealth Mindfulness	Group telehealth mindfulness	Telehealth mindfulness sessions delivered in a small-group format with mindfulness therapist
Individual telehealth mindfulness	Individual telehealth mindfulness	Telehealth mindfulness sessions delivered one-on-one with mindfulness therapist

Primary Outcome Measures

Name	Time	Method
Acceptability - Satisfaction With Intervention	3 months following lumbar spine surgery	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)
Feasibility - Session Attendance	3 months following lumbar spine surgery	Percent of sessions attended out of 8
Feasibility - Study Retention	3 months following lumbar spine surgery	Percentage of participants enrolled who complete the study

Secondary Outcome Measures

Name	Time	Method
Depression Short Form 4a	3 months postoperative	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.
Pain Self-efficacy Questionnaire	3 months postoperative	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.
Pain Bothersomeness	3 months postoperative	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.
Perceived Stress Scale - 4	3 months postoperative	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.
Five Facet Mindfulness Questionnaire - 15	3 months postoperative	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.
Back and Leg Pain Intensity	3 months postoperative	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.
Pain Interference Short-form 4a	3 months postoperative	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.
Overall Pain Intensity	3 months postoperative	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.
Self-reported Opioid Medication Use	3 months postoperative	Measured as average number of opioid pills per day (name and dose specified) and converted to morphine equivalent dose.
Anxiety Short Form 4a	3 months postoperative	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.
Tampa Scale for Kinesiophobia -13	3 months postoperative	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.
Oswestry Disability Index	3 months postoperative	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.
Pain Catastrophizing Scale	3 months postoperative	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.