Trial Outcomes & Findings for Chronic Pain Skills Study - Vanderbilt University Medical Center (NCT 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.

Recruitment status

COMPLETED

Study phase

Target enrollment

103 participants

Primary outcome timeframe

baseline and 6 months

Results posted on

2020-04-21

Participant Flow

Participant milestones

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

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=5 Participants	44.833 years STANDARD_DEVIATION 13.402 • n=7 Participants	50.462 years STANDARD_DEVIATION 13.925 • n=5 Participants
Sex: Female, Male Female	65 Participants n=5 Participants	9 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	3 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	75 Participants n=5 Participants	10 Participants n=7 Participants	85 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	0 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	91 participants n=5 Participants	12 participants n=7 Participants	103 participants n=5 Participants
Brief Pain Inventory	5.472 units on a scale STANDARD_DEVIATION 1.736 • n=5 Participants	6.125 units on a scale STANDARD_DEVIATION 1.721 • n=7 Participants	5.549 units on a scale STANDARD_DEVIATION 1.739 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and 6 months

Population: Patients who completed 6-month post-treatment follow-up

Outcome measures

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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clinical Hypnosis - Individual Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Phone: 615-320-7770

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place