Trial Outcomes & Findings for Chronic Pain Skills Study - Vanderbilt University Medical Center (NCT NCT03384953)
NCT ID: NCT03384953
Last Updated: 2020-04-21
Results Overview
Brief Pain Inventory (severity scale only) is a 4-item subscale of the Brief Pain Inventory assessing the severity of pain over the past week. Questions inquire into an individual's worst, least, average, and current levels of pain on an 11-point likert scale, with 0 being no pain. It has been validated and is considered the gold standard to utilize in patient-reported outcomes studies. It takes \<1 minute to complete.
COMPLETED
NA
103 participants
baseline and 6 months
2020-04-21
Participant Flow
Participant milestones
| Measure |
Clinical Hypnosis - Group Treatment
Subjects will receive 8 weeks of a manualized clinical hypnosis for chronic pain treatment in a group setting. Assessments will be completed before, immediately after, and at 3- and 6- months post-treatment to assess for treatment gains.
Clinical Hypnosis - Group Treatment: group treatment
|
Clinical Hypnosis - Individual Treatment
Subjects will receive 8 weeks of a manualized clinical hypnosis for chronic pain treatment in an individual, 1:1 setting. Assessments will be completed before, immediately after, and at 3- and 6- months post-treatment to assess for treatment gains.
Clinical Hypnosis - Individual Treatment: individual treatment
|
|---|---|---|
|
Overall Study
STARTED
|
91
|
12
|
|
Overall Study
Completed Treatment
|
68
|
6
|
|
Overall Study
COMPLETED
|
51
|
4
|
|
Overall Study
NOT COMPLETED
|
40
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chronic Pain Skills Study - Vanderbilt University Medical Center
Baseline characteristics by cohort
| Measure |
Clinical Hypnosis - Group Treatment
n=91 Participants
Subjects will receive 8 weeks of a manualized clinical hypnosis for chronic pain treatment in a group setting. Assessments will be completed before, immediately after, and at 3- and 6- months post-treatment to assess for treatment gains.
Clinical Hypnosis - Group Treatment: group treatment
|
Clinical Hypnosis - Individual Treatment
n=12 Participants
Subjects will receive 8 weeks of a manualized clinical hypnosis for chronic pain treatment in an individual, 1:1 setting. Assessments will be completed before, immediately after, and at 3- and 6- months post-treatment to assess for treatment gains.
Clinical Hypnosis - Individual Treatment: individual treatment
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.196 years
STANDARD_DEVIATION 13.894 • n=99 Participants
|
44.833 years
STANDARD_DEVIATION 13.402 • n=107 Participants
|
50.462 years
STANDARD_DEVIATION 13.925 • n=206 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
91 participants
n=99 Participants
|
12 participants
n=107 Participants
|
103 participants
n=206 Participants
|
|
Brief Pain Inventory
|
5.472 units on a scale
STANDARD_DEVIATION 1.736 • n=99 Participants
|
6.125 units on a scale
STANDARD_DEVIATION 1.721 • n=107 Participants
|
5.549 units on a scale
STANDARD_DEVIATION 1.739 • n=206 Participants
|
PRIMARY outcome
Timeframe: baseline and 6 monthsPopulation: Patients who completed 6-month post-treatment follow-up
Brief Pain Inventory (severity scale only) is a 4-item subscale of the Brief Pain Inventory assessing the severity of pain over the past week. Questions inquire into an individual's worst, least, average, and current levels of pain on an 11-point likert scale, with 0 being no pain. It has been validated and is considered the gold standard to utilize in patient-reported outcomes studies. It takes \<1 minute to complete.
Outcome measures
| Measure |
Clinical Hypnosis - Group Treatment
n=51 Participants
Subjects will receive 8 weeks of a manualized clinical hypnosis for chronic pain treatment in a group setting. Assessments will be completed before, immediately after, and at 3- and 6- months post-treatment to assess for treatment gains.
Clinical Hypnosis - Group Treatment: group treatment
|
Clinical Hypnosis - Individual Treatment
n=4 Participants
Subjects will receive 8 weeks of a manualized clinical hypnosis for chronic pain treatment in an individual, 1:1 setting. Assessments will be completed before, immediately after, and at 3- and 6- months post-treatment to assess for treatment gains.
Clinical Hypnosis - Individual Treatment: individual treatment
|
|---|---|---|
|
Change in Pain Intensity
|
4.42 units on a scale
Standard Deviation 2.173
|
6.625 units on a scale
Standard Deviation 1.422
|
Adverse Events
Clinical Hypnosis - Group Treatment
Clinical Hypnosis - Individual Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Lindsey C. McKernan
Osher Center for Integrative Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place