Back Pain, Complex Regional Pain Syndromes
Conditions
Brief summary
To assess treatment with an at-home Virtual Reality Guided Imagery (VR-GI) intervention, 36 patients with chronic pain (18 with chronic back pain, CBP, and 18 with complex regional pain syndrome, CRPS) will complete a 2-week intervention with at-home daily practice of VR-GI (n = 24) or audio-only GI (n = 12). Pre-post treatment measures of pain intensity, opioid use, functional outcomes, and mood will be collected. Intervention feasibility and patient satisfaction will be evaluated post-treatment via questionnaire and qualitative interview.
Detailed description
○ Chronic pain affects over 100 million adults in the US, resulting in disability, loss of work productivity, and overall reductions in health, making chronic pain a major public health problem with an economic burden estimated at $560-635 billion annually. Opioids, the most frequently prescribed class of drugs to control pain, lack evidence supporting their long-term efficacy and carry a 15-26% risk of misuse and abuse among pain patients, highlighting a critical need to develop effective non-pharmacological interventions for pain. Guided imagery (GI), a cognitive-behavioral technique for guiding patients to create multisensory, imagined scenes to increase well-being, is an effective non-pharmacological intervention for reducing pain. However, its effectiveness is limited by patients' imaging abilities. The long-term objective of this project is to reduce chronic pain and opioid use by developing an at-home virtual reality (VR)-GI intervention to improve chronic pain management using the Limbix VR Kit. Given the enhanced immersiveness and interactivity of VR, VR-GI is expected to reduce pain and reliance on opioids, as well as improve functional outcomes and mood, compared to traditional audio-only GI and usual care. The specific aims are to evaluate feasibility and usability of an at-home VRGI intervention in a 2-week clinical trial. Two 15-min VR-GI experiences that guide patients through psychoeducation, relaxation exercises, and interactive virtual worlds that allow them to control their experience of pain will be evaluated. To assess feasibility of an at-home VR-GI intervention, 36 patients with chronic pain (18 with chronic back pain, CBP, and 18 with complex regional pain syndrome, CRPS) will complete a 2-week intervention with at-home daily practice of VR-GI (n = 24) or audio-only GI (n = 12). Pre-post treatment measures of pain intensity, opioid use, functional outcomes, and mood will be collected. Intervention feasibility and patient satisfaction will be evaluated post-treatment via questionnaire and qualitative interview. This research directly addresses the need to improve pain treatment to prevent opioid use disorder.
Interventions
DEVICEExperimental: Virtual Reality Guided Imagery
Platform and VR Goggles
OTHERActive Comparator: Audio Only Guided Imagery
Audio Recordings of Guided Imagery via an iPAD
Sponsors
Limbix Health, Inc.
BehaVR LLC
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be a patient at the University of Southern California Pain Center * \- English Fluency * Diagnosis of chronic back pain or complex regional pain syndrome * Average pain intensity of 5 on a 0 to 10 scale for more than 3 month * Access to a device with video and audio capability and sufficient WiFI to participate in on-line sessions
Exclusion criteria
* History of significant motion sickness * Active nausea/vomiting * Epilepsy * Significant movement problems * Significant vision or hearing impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-opioid Pain Medication Usage Assessed by Frequency of Use Log | Baseline to 2 week follow up | Log with list of non-opioid pain mediction taken, dosages and frequency of use. Lower frequency of use indicates better outcomes |
| Number of Participants Who Are Recruited But Not Enrolled as Documented in Participant Log | Baseline | Participant log tracks number of recruited participants who are ineligible to participate and/or decline to enroll |
| Number of Enrolled Participants Who do Not Complete the Study as Documented in Log | Baseline to 2 week follow up | Participant log tracks the number of enrolled participants who discontinue intervention, are lost to follow-up and/or experience adverse events. |
| Number of Practice Sessions Completed by Participants as Documented in Spread Sheet | Baseline to 2 week follow up | Spread sheet documenting proportion of at-home daily GI practice completed over 2-week intervention |
| Pain Assessed by Pain Numeric Rating Scale | Baseline to 2 week follow up | Numeric Rating Scale of self-reported highest, lowest, and average pain scores (0-10) over the last 7 days. Higher scores indicate worse pain outcomes. |
| Opioid Medication Usage Assessed by Frequency of Use Log | Baseline to 2 week follow up | Log with list of medications taken, dosages and frequency of use. Lower frequency indicates better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Assessed by Generalized Anxiety Disorder Assessment: GAD-2 (GAD-7) | Baseline to 2 week follow up | Generalized Anxiety Disorder Assessment is calculated by assigning scores of 1,2,3 and 4, to the response categories of Not at all sure, Several Days,Over half the days, Nearly every day , respectively. Total score for the two ranges from 0-6 with higher number indicating worse anxiety outcome. |
| Depression Assessed by the Patient Health Questionnaire PHQ-2 | Baseline to 2 week follow up | Patient Health Questionnaire is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of not at all, several days more than half the days, and-nearly every day, respectively. Total score for the two ranges from 0 to 6 with higher number worse depression outcome. |
| Short Form Health Survey (SF12v12) | Baseline to 2 week follow up | Health-related quality of life assessment Short Form Health Survey 12 has two composite scores (Physical composite score and Mental composite score). Each score has a range of 0 to 100 with higher scores indicating better health outcomes. |
| Back Pain Disability Assessed by the Back Pain Oswestry Disability Index (ODI) | Baseline to 2 week follow up | Pain Management assessments for patients with back pain. Oswestry Disability Index For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5 with 50 as a highest score; higher scores indicating a worse disability outcome from back pain. Scale is 0-50. |
| Complex Regional Pain Syndrome Symptoms Assessed by the CSS 17 Patientobservation Portion | Baseline to 2 week follow up | Pain management assessments for patients with CRPS. Complex Regional Pain Syndrome (CRPS) Severity Score (CSS-17) 0 absence of symptoms, 1 presence of symptoms, 0-8, higher score indicate worse symptom outcome. |
| Daily Pain Numerical Rating Scale | Baseline to 2 week follow up | Rating of current pain intensity from 0-10 with higher number indicated worse pain outcomes |
Countries
United States
Participant flow
Pre-assignment details
96 applicants were recruited, 81 met inclusion criteria. 36 participants were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Audio Only Guided Imagery (AO-GI) Listen to narrative scripts based on traditional GI audio recordings. The narrative scripts will include psychoeducation content that explains how the mind and brain can influence physical pain and how they can be trained to effect changes in experienced chronic pain. Narration will guide users in breathing and relaxation exercises and explain how patients can continue to exert control over their pain outside of the GI experience. | 12 |
| Virtual Reality Guided Imagery (VR-GI) VR headset for guided imagery with audiovisual computer-generated VR content to accompany the GI narration. The narrative scripts will include psychoeducation content that explains how the mind and brain can influence physical pain and how they can be trained to effect changes in experienced chronic pain. Narration will guide users in breathing and relaxation exercises and explain how patients can continue to exert control over their pain outside of the VR-GI experience. | 24 |
| Total | 36 |
Baseline characteristics
| Characteristic | Audio Only Guided Imagery (AO-GI) | Virtual Reality Guided Imagery (VR-GI) | Total |
|---|---|---|---|
| Age, Customized age greater than 18 | 12 Participants | 24 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 4 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 19 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) White | 9 Participants | 18 Participants | 27 Participants |
| Sex: Female, Male Female | 10 Participants | 16 Participants | 26 Participants |
| Sex: Female, Male Male | 2 Participants | 8 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 12 |
| other Total, other adverse events | 5 / 23 | 0 / 12 |
| serious Total, serious adverse events | 0 / 23 | 0 / 12 |
Outcome results
Primary
Non-opioid Pain Medication Usage Assessed by Frequency of Use Log
Log with list of non-opioid pain mediction taken, dosages and frequency of use. Lower frequency of use indicates better outcomes
Time frame: Baseline to 2 week follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Recruited | Non-opioid Pain Medication Usage Assessed by Frequency of Use Log | 6 Pt. count reduced non-opoid pain med use |
| Audio Only Guided Imagery (AO-GI) | Non-opioid Pain Medication Usage Assessed by Frequency of Use Log | 3 Pt. count reduced non-opoid pain med use |
Primary
Number of Enrolled Participants Who do Not Complete the Study as Documented in Log
Participant log tracks the number of enrolled participants who discontinue intervention, are lost to follow-up and/or experience adverse events.
Time frame: Baseline to 2 week follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Recruited | Number of Enrolled Participants Who do Not Complete the Study as Documented in Log | 3 Participants |
| Audio Only Guided Imagery (AO-GI) | Number of Enrolled Participants Who do Not Complete the Study as Documented in Log | 1 Participants |
Primary
Number of Participants Who Are Recruited But Not Enrolled as Documented in Participant Log
Participant log tracks number of recruited participants who are ineligible to participate and/or decline to enroll
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Recruited | Number of Participants Who Are Recruited But Not Enrolled as Documented in Participant Log | 60 Participants |
Primary
Number of Practice Sessions Completed by Participants as Documented in Spread Sheet
Spread sheet documenting proportion of at-home daily GI practice completed over 2-week intervention
Time frame: Baseline to 2 week follow up
Population: For the VR-Gi group, 23 participants were analyzed as one participant did not receive allocated intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Recruited | Number of Practice Sessions Completed by Participants as Documented in Spread Sheet | 10.8 Daily ratings completed | Standard Deviation 3.58 |
| Audio Only Guided Imagery (AO-GI) | Number of Practice Sessions Completed by Participants as Documented in Spread Sheet | 11.4 Daily ratings completed | Standard Deviation 4.27 |
Primary
Opioid Medication Usage Assessed by Frequency of Use Log
Log with list of medications taken, dosages and frequency of use. Lower frequency indicates better outcomes.
Time frame: Baseline to 2 week follow up
Population: For the VR-GI group, 3 participants were analyzed as others did not have opioid usage. For the AO-GI group, 4 participants were analyzed as others did not have opioid usage.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Recruited | Opioid Medication Usage Assessed by Frequency of Use Log | 0 Count of Participants with Reduced Opioi |
| Audio Only Guided Imagery (AO-GI) | Opioid Medication Usage Assessed by Frequency of Use Log | 1 Count of Participants with Reduced Opioi |
Primary
Pain Assessed by Pain Numeric Rating Scale
Numeric Rating Scale of self-reported highest, lowest, and average pain scores (0-10) over the last 7 days. Higher scores indicate worse pain outcomes.
Time frame: Baseline to 2 week follow up
Population: For the VR-GI group, 23 participants were analyzed as one participant did not receive allocated intervention. For the AO-GI group, 11 participants were analyzed as one participant did not complete post-intervention questionnaires.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Recruited | Pain Assessed by Pain Numeric Rating Scale | Highest Score Baseline | 8.42 units on a scale | Standard Deviation 0.83 |
| Total Recruited | Pain Assessed by Pain Numeric Rating Scale | Lowest Score Follow up | 3.71 units on a scale | Standard Deviation 1.95 |
| Total Recruited | Pain Assessed by Pain Numeric Rating Scale | Highest Score Follow-up | 7.86 units on a scale | Standard Deviation 1.01 |
| Total Recruited | Pain Assessed by Pain Numeric Rating Scale | Lowest Score Baseline | 4 units on a scale | Standard Deviation 1.82 |
| Total Recruited | Pain Assessed by Pain Numeric Rating Scale | Change in Average Score Follow-up-baseline | 0.524 units on a scale | Standard Deviation 1.08 |
| Total Recruited | Pain Assessed by Pain Numeric Rating Scale | Change in Highest Score Follow-up-Baseline | 0.619 units on a scale | Standard Deviation 0.973 |
| Total Recruited | Pain Assessed by Pain Numeric Rating Scale | Average Score Baseline | 6.08 units on a scale | Standard Deviation 1.18 |
| Total Recruited | Pain Assessed by Pain Numeric Rating Scale | Average Score Follow-up | 5.62 units on a scale | Standard Deviation 1.5 |
| Total Recruited | Pain Assessed by Pain Numeric Rating Scale | Change in Lowest Score Follow up Baseline | 0.381 units on a scale | Standard Deviation 1.36 |
| Audio Only Guided Imagery (AO-GI) | Pain Assessed by Pain Numeric Rating Scale | Average Score Follow-up | 5.46 units on a scale | Standard Deviation 1.44 |
| Audio Only Guided Imagery (AO-GI) | Pain Assessed by Pain Numeric Rating Scale | Change in Lowest Score Follow up Baseline | 0.091 units on a scale | Standard Deviation 1.04 |
| Audio Only Guided Imagery (AO-GI) | Pain Assessed by Pain Numeric Rating Scale | Lowest Score Baseline | 3.92 units on a scale | Standard Deviation 1.51 |
| Audio Only Guided Imagery (AO-GI) | Pain Assessed by Pain Numeric Rating Scale | Lowest Score Follow up | 3.64 units on a scale | Standard Deviation 1.63 |
| Audio Only Guided Imagery (AO-GI) | Pain Assessed by Pain Numeric Rating Scale | Change in Highest Score Follow-up-Baseline | 0.100 units on a scale | Standard Deviation 1.37 |
| Audio Only Guided Imagery (AO-GI) | Pain Assessed by Pain Numeric Rating Scale | Highest Score Baseline | 7.75 units on a scale | Standard Deviation 1.36 |
| Audio Only Guided Imagery (AO-GI) | Pain Assessed by Pain Numeric Rating Scale | Highest Score Follow-up | 7.4 units on a scale | Standard Deviation 0.97 |
| Audio Only Guided Imagery (AO-GI) | Pain Assessed by Pain Numeric Rating Scale | Change in Average Score Follow-up-baseline | 0.182 units on a scale | Standard Deviation 1.08 |
| Audio Only Guided Imagery (AO-GI) | Pain Assessed by Pain Numeric Rating Scale | Average Score Baseline | 5.75 units on a scale | Standard Deviation 1.42 |
Secondary
Anxiety Assessed by Generalized Anxiety Disorder Assessment: GAD-2 (GAD-7)
Generalized Anxiety Disorder Assessment is calculated by assigning scores of 1,2,3 and 4, to the response categories of Not at all sure, Several Days,Over half the days, Nearly every day , respectively. Total score for the two ranges from 0-6 with higher number indicating worse anxiety outcome.
Time frame: Baseline to 2 week follow up
Population: For the VR-GI group, 23 participants were analyzed as one participant did not receive allocated intervention. For the AO-GI group, 11 participants were analyzed as one participant did not complete post-intervention questionnaires.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Recruited | Anxiety Assessed by Generalized Anxiety Disorder Assessment: GAD-2 (GAD-7) | Change in GAD (Follow up-Baseline | -1.2 score on GAD-2 scale | Standard Deviation 1.2 |
| Total Recruited | Anxiety Assessed by Generalized Anxiety Disorder Assessment: GAD-2 (GAD-7) | GAD Baseline | 1.83 score on GAD-2 scale | Standard Deviation 1.86 |
| Total Recruited | Anxiety Assessed by Generalized Anxiety Disorder Assessment: GAD-2 (GAD-7) | GAD Follow-up | 0.9 score on GAD-2 scale | Standard Deviation 1.17 |
| Audio Only Guided Imagery (AO-GI) | Anxiety Assessed by Generalized Anxiety Disorder Assessment: GAD-2 (GAD-7) | Change in GAD (Follow up-Baseline | -.06 score on GAD-2 scale | Standard Deviation 1.17 |
| Audio Only Guided Imagery (AO-GI) | Anxiety Assessed by Generalized Anxiety Disorder Assessment: GAD-2 (GAD-7) | GAD Baseline | 1.58 score on GAD-2 scale | Standard Deviation 1.68 |
| Audio Only Guided Imagery (AO-GI) | Anxiety Assessed by Generalized Anxiety Disorder Assessment: GAD-2 (GAD-7) | GAD Follow-up | 1.2 score on GAD-2 scale | Standard Deviation 1.55 |
Secondary
Back Pain Disability Assessed by the Back Pain Oswestry Disability Index (ODI)
Pain Management assessments for patients with back pain. Oswestry Disability Index For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5 with 50 as a highest score; higher scores indicating a worse disability outcome from back pain. Scale is 0-50.
Time frame: Baseline to 2 week follow up
Population: For the VR-GI group, 9 participants out of the 12 participants with a CBP diagnosis were analyzed as 1 participant did not receive intervention, 1 participant discontinued intervention, and 1 did not complete a post-intervention questionnaire. For the AO-GI group, 6 participants were analyzed as they had a CBP diagnosis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Recruited | Back Pain Disability Assessed by the Back Pain Oswestry Disability Index (ODI) | Change in ODI (Follow-up - Baseline) | -3.44 score on Oswestry Disability scale | Standard Deviation 3.4 |
| Total Recruited | Back Pain Disability Assessed by the Back Pain Oswestry Disability Index (ODI) | ODI Baseline | 24.6 score on Oswestry Disability scale | Standard Deviation 5.66 |
| Total Recruited | Back Pain Disability Assessed by the Back Pain Oswestry Disability Index (ODI) | ODI Follow up | 20.8 score on Oswestry Disability scale | Standard Deviation 5.65 |
| Audio Only Guided Imagery (AO-GI) | Back Pain Disability Assessed by the Back Pain Oswestry Disability Index (ODI) | Change in ODI (Follow-up - Baseline) | -4.83 score on Oswestry Disability scale | Standard Deviation 7.65 |
| Audio Only Guided Imagery (AO-GI) | Back Pain Disability Assessed by the Back Pain Oswestry Disability Index (ODI) | ODI Baseline | 25.8 score on Oswestry Disability scale | Standard Deviation 8.98 |
| Audio Only Guided Imagery (AO-GI) | Back Pain Disability Assessed by the Back Pain Oswestry Disability Index (ODI) | ODI Follow up | 21 score on Oswestry Disability scale | Standard Deviation 9.07 |
Secondary
Complex Regional Pain Syndrome Symptoms Assessed by the CSS 17 Patientobservation Portion
Pain management assessments for patients with CRPS. Complex Regional Pain Syndrome (CRPS) Severity Score (CSS-17) 0 absence of symptoms, 1 presence of symptoms, 0-8, higher score indicate worse symptom outcome.
Time frame: Baseline to 2 week follow up
Population: CSS-17 was unreported due to participants receiving an incomplete CSS-17 questionnaire.
Secondary
Daily Pain Numerical Rating Scale
Rating of current pain intensity from 0-10 with higher number indicated worse pain outcomes
Time frame: Baseline to 2 week follow up
Population: For the VR-GI group, 23 participants were analyzed as one participant did not receive allocated intervention. For the AO-GI group, 11 participants were analyzed as one participant did not complete post-intervention questionnaires.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Recruited | Daily Pain Numerical Rating Scale | Change in Pain Score (Follow-up - Baseline) | -0.906 difference score on pain scale | Standard Deviation 0.851 |
| Total Recruited | Daily Pain Numerical Rating Scale | Pre Pain Score | 5.75 difference score on pain scale | Standard Deviation 1.5 |
| Total Recruited | Daily Pain Numerical Rating Scale | Post pain Score | 4.82 difference score on pain scale | Standard Deviation 1.48 |
| Audio Only Guided Imagery (AO-GI) | Daily Pain Numerical Rating Scale | Change in Pain Score (Follow-up - Baseline) | -.757 difference score on pain scale | Standard Deviation 0.489 |
| Audio Only Guided Imagery (AO-GI) | Daily Pain Numerical Rating Scale | Pre Pain Score | 5.49 difference score on pain scale | Standard Deviation 1.41 |
| Audio Only Guided Imagery (AO-GI) | Daily Pain Numerical Rating Scale | Post pain Score | 4.8 difference score on pain scale | Standard Deviation 1.47 |
Secondary
Depression Assessed by the Patient Health Questionnaire PHQ-2
Patient Health Questionnaire is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of not at all, several days more than half the days, and-nearly every day, respectively. Total score for the two ranges from 0 to 6 with higher number worse depression outcome.
Time frame: Baseline to 2 week follow up
Population: For the VR-GI group, 23 participants were analyzed as one participant did not receive allocated intervention. For the AO-GI group, 11 participants were analyzed as one participant did not complete post-intervention questionnaires.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Recruited | Depression Assessed by the Patient Health Questionnaire PHQ-2 | Change in PHQ (Follow up-Baseline) | -1.10 score on PHQ-2 scale | Standard Deviation 1.34 |
| Total Recruited | Depression Assessed by the Patient Health Questionnaire PHQ-2 | PHQ Baseline | 2 score on PHQ-2 scale | Standard Deviation 1.53 |
| Total Recruited | Depression Assessed by the Patient Health Questionnaire PHQ-2 | PHQ Follow-up | 0.86 score on PHQ-2 scale | Standard Deviation 1.39 |
| Audio Only Guided Imagery (AO-GI) | Depression Assessed by the Patient Health Questionnaire PHQ-2 | Change in PHQ (Follow up-Baseline) | 0 score on PHQ-2 scale | Standard Deviation 0.47 |
| Audio Only Guided Imagery (AO-GI) | Depression Assessed by the Patient Health Questionnaire PHQ-2 | PHQ Baseline | 1.33 score on PHQ-2 scale | Standard Deviation 1.44 |
| Audio Only Guided Imagery (AO-GI) | Depression Assessed by the Patient Health Questionnaire PHQ-2 | PHQ Follow-up | 1.3 score on PHQ-2 scale | Standard Deviation 1.7 |
Secondary
Short Form Health Survey (SF12v12)
Health-related quality of life assessment Short Form Health Survey 12 has two composite scores (Physical composite score and Mental composite score). Each score has a range of 0 to 100 with higher scores indicating better health outcomes.
Time frame: Baseline to 2 week follow up
Population: For the VR-GI group, 23 participants were analyzed as one participant did not receive allocated intervention. For the AO-GI group, 11 participants were analyzed as one participant did not complete post-intervention questionnaires.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Recruited | Short Form Health Survey (SF12v12) | Change in Physical Score (Follow-up- Baseline) | 7.3 score on SF 12 scale | Standard Deviation 6.42 |
| Total Recruited | Short Form Health Survey (SF12v12) | Physical Score Baseline | 27.0 score on SF 12 scale | Standard Deviation 6.87 |
| Total Recruited | Short Form Health Survey (SF12v12) | Physical Score Follow up | 27.9 score on SF 12 scale | Standard Deviation 8.61 |
| Total Recruited | Short Form Health Survey (SF12v12) | Change in Mental Score (Follow-up - Baseline) | 6.56 score on SF 12 scale | Standard Deviation 7.25 |
| Total Recruited | Short Form Health Survey (SF12v12) | Mental Score Baseline | 43.6 score on SF 12 scale | Standard Deviation 12.3 |
| Total Recruited | Short Form Health Survey (SF12v12) | Mental Score Follow up | 50.4 score on SF 12 scale | Standard Deviation 10.2 |
| Audio Only Guided Imagery (AO-GI) | Short Form Health Survey (SF12v12) | Mental Score Baseline | 43.5 score on SF 12 scale | Standard Deviation 13.1 |
| Audio Only Guided Imagery (AO-GI) | Short Form Health Survey (SF12v12) | Change in Physical Score (Follow-up- Baseline) | -1.85 score on SF 12 scale | Standard Deviation 6.81 |
| Audio Only Guided Imagery (AO-GI) | Short Form Health Survey (SF12v12) | Change in Mental Score (Follow-up - Baseline) | 5.65 score on SF 12 scale | Standard Deviation 7.89 |
| Audio Only Guided Imagery (AO-GI) | Short Form Health Survey (SF12v12) | Physical Score Baseline | 29.1 score on SF 12 scale | Standard Deviation 4.8 |
| Audio Only Guided Imagery (AO-GI) | Short Form Health Survey (SF12v12) | Mental Score Follow up | 48.6 score on SF 12 scale | Standard Deviation 16.2 |
| Audio Only Guided Imagery (AO-GI) | Short Form Health Survey (SF12v12) | Physical Score Follow up | 27.7 score on SF 12 scale | Standard Deviation 7.22 |