Breast Cancer Female, Depressive Symptoms, Emotions, Fatigue, Inflammation, Pain
Conditions
Keywords
Emotion Processing, Art Therapy, Breast Cancer, Cholinergic anti-inflammatory pathway
Brief summary
The purpose of this study is to examine two mechanistic changes: emotion processing (awareness, expression and acceptance) and cholinergic anti-inflammatory processes (HRV and cytokine expression) through which an Art Therapy (AT) intervention reduces depression, pain and fatigue.
Detailed description
The study is a randomized controlled study with careful controls. Our study population is comprised of 240 BC patients in palliative and curative care (comprised of 50% Jewish and 50% Arab). This population will be randomized to receive a standard art therapy intervention or a comparison group. The AT intervention is an 8-week group intervention comprised of 8 1.5 hour weekly sessions conducted by an experienced Art Therapist The comparison group will engage in the coloring of prefabricated shapes (mandalas) and will receive Psychoeducation on topics related to coping with BC, identical to the topics of the AT group. This design will allow the study to test the mechanism of AT that is beyond the effects of time with a group, focus on a task and engagement with art materials.
Interventions
In a group setting participants will be encouraged to engage in art making for increased emotional awareness, expression, and acceptance. The role of the art therapist is to encourage a non-judgmental and exploratory approach to artmaking in which the process is emphasized over product. The art therapist obtains these goals by creating an atmosphere that is calm and by remaining tuned in to the verbalizations and body language of participants. If needed she can provide individual attention that is geared toward neutralizing concerns regarding performance during the art making.
In a group setting participants will engage in Mandala coloring
Sponsors
Study design
Masking description
The control group is designed to be similar to the intervention, participants will be engaged in interacting with art materials. Research assistants will be blinded to group allocation when collecting data.
Eligibility
Inclusion criteria
* adult (\>18) females with initial or recurrent BC * intervention can begin 3 months after finishing chemotherapy and radiotherapy (RT) and one month after surgery, up until 18 months after treatment completion. * can complete assessments in Arabic or Hebrew * provides informed consent.
Exclusion criteria
* male * lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder or with a pre- cancer diagnosis of fibromyalgia or chronic fatigue syndrome * active suicidal plan (will ensure immediate intervention); * dementia/other disorder that would preclude informed consent or comprehension of assessments * Individuals taking anticholinergic medications, and post myocardial infarction (6 months before recruitment) or with a pacemaker, which would render the metric of HRV invalid. * Flare-up in systemic autoimmune disease (such as arthritis, lupus or multiple sclerosis), thyroid dysfunction that requires increases in medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression Depression | Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3) | The Center for Epidemiologic Studies-Depression (CES-D) 10-item scale. The possible range of scores is zero to 50, with the higher scores indicating the presence of more symptomatology. |
| Fatigue | Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3) | Fatigue will be assessed using the Fatigue Symptom Inventory (FSI), a 14-item self-report measure designed to assess the severity of fatigue on an 11-point scale (0=not at all fatigued; 10=as fatigued as I could be) that assesses most, least, and average fatigue in the past week. A global score can be obtained summing items 1-13, resulting in a scale with a range between 0-130. Higher results represent higher levels of global fatigue. |
| Pain (Impact and Interference) | Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3) | The PROMIS Pain impact Scale measures how much pain impacted different aspects of life in the past 7 days. Scores range from 0-to-60, higher scores indicating higher levels of pain or its impact on functioning and the PROMIS Pain Interference Scale measures how much pain interfered with different aspects of life in the past 7 days. Scores range from 0-to-60, higher scores indicating higher levels of pain or interference with functioning. Our data indicates t-scores calculated so that 50 indicates the population (cancer patient) mean with a standard deviation of 10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammation | Changes will be measured from baseline (T1), after the intervention, 8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3). | We collected 10 ccs of blood in order to measure immune regulation (pro-inflammatory cytokines IL-6, IL-8, IL-1β, TNF-α), anti-inflammatory (IL-4, IL-10) and regulatory cytokines (TGF-β). |
| Emotional Awareness | Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3) | The Levels of Emotional Awareness Scale is a written performance index of ability to express emotion in a differentiated and complex way. Subjects write about their anticipated feelings and those of another person in response to 10 short vignettes. Responses are scored on a 1 - 4 range and summed up to create a range of 0-50 according to the degree of specificity in the terms used and the range of emotions described, higher scores indicating higher levels of awareness. |
| Heart Rate Variability | Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline, T2) and 8 weeks after the intervention ends (T3) | 20 minutes of resting ECG data will be recorded. The participants will be given instructions not to drink coffee or smoke for 3 hours before the lab visit as well as to sit quietly without talking or moving during the ECG recording. These are physiological data without a specific range, however in our study, for example, at T1 in the art therapy group the measurements ranged from 7.56 to 113.28 miliseconds. |
| Emotional Expression | Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline (T2), and 8 weeks after the intervention ends (T3) | This is a 36-item scale in which participants respond on a Likert scale from 1 (I don't do this at all) to 4 (I do this a lot) regarding how they coped with breast cancer experiences in the past four weeks. Two subscales are created from means of items: Approach Coping composite (24 items), and Avoidance composite (12 items) each with a range from 1-4 . Higher scores indicate more approach-oriented or avoidance-oriented coping. Participants rated items on a response scale of 1 (''I don't do this at all'') to 4 (''I do this a lot''). |
| Acceptance of Emotions | Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3) | The Acceptance of Emotions Scale assesses the extent to which subjects are accepting and nurturing toward their feelings, ranging 0-100, higher scores indicate higher acceptance of emotion. |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Art Therapy The AT intervention is an 8-week group intervention comprised of 8 1.5 hour weekly sessions conducted by an experienced Art Therapist who received special training in conducting the treatment protocol as designed.
Art Therapy: In a group setting participants will be encouraged to engage in art making for increased emotional awareness, expression, and acceptance. The role of the art therapist is to encourage a non-judgmental and exploratory approach to artmaking in which the process is emphasized over product. The art therapist obtains these goals by creating an atmosphere that is calm and by remaining tuned in to the verbalizations and body language of participants. If needed she can provide individual attention that is geared toward neutralizing concerns regarding performance during the art making. | 146 |
| Mandala Group The comparison group will color prefabricated shapes. The same art materials as in the intervention group will be on the table as will the same instrumental music.
Sham Art Therapy: In a group setting participants will engage in Mandala coloring | 143 |
| Total | 289 |
Baseline characteristics
| Characteristic | Art Therapy | Mandala Group | Total |
|---|---|---|---|
| Age, Customized Age 26-35 | 9 Participants | 5 Participants | 14 Participants |
| Age, Customized Age 36-45 | 31 Participants | 23 Participants | 54 Participants |
| Age, Customized Age 46-70 | 80 Participants | 85 Participants | 165 Participants |
| Age, Customized Age 70+ | 9 Participants | 9 Participants | 18 Participants |
| Age, Customized Age missing | 17 Participants | 21 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 146 Participants | 143 Participants | 289 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Israel | 146 participants | 143 participants | 289 participants |
| Sex: Female, Male Female | 146 Participants | 143 Participants | 289 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 146 | 1 / 143 |
| other Total, other adverse events | 16 / 146 | 15 / 143 |
| serious Total, serious adverse events | 8 / 146 | 6 / 143 |
Outcome results
Depression Depression
The Center for Epidemiologic Studies-Depression (CES-D) 10-item scale. The possible range of scores is zero to 50, with the higher scores indicating the presence of more symptomatology.
Time frame: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)
Population: The posted data are raw, before multiple imputations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Art Therapy | Depression Depression | T2 | 9.86 score on a scale | Standard Deviation 6.203 |
| Art Therapy | Depression Depression | T3 | 11.05 score on a scale | Standard Deviation 5.67 |
| Art Therapy | Depression Depression | T1 | 10.82 score on a scale | Standard Deviation 6.01 |
| Mandala Group | Depression Depression | T2 | 11.23 score on a scale | Standard Deviation 5.45 |
| Mandala Group | Depression Depression | T1 | 11.57 score on a scale | Standard Deviation 6.46 |
| Mandala Group | Depression Depression | T3 | 11.72 score on a scale | Standard Deviation 5.59 |
Fatigue
Fatigue will be assessed using the Fatigue Symptom Inventory (FSI), a 14-item self-report measure designed to assess the severity of fatigue on an 11-point scale (0=not at all fatigued; 10=as fatigued as I could be) that assesses most, least, and average fatigue in the past week. A global score can be obtained summing items 1-13, resulting in a scale with a range between 0-130. Higher results represent higher levels of global fatigue.
Time frame: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)
Population: We utilized full maximum likelihood, and the numbers presented here are raw data in which if an individual missed one item from the scale, it was marked as missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Art Therapy | Fatigue | T1 | 61.35 score on a scale | Standard Deviation 28.77 |
| Art Therapy | Fatigue | T2 | 53.28 score on a scale | Standard Deviation 29.4 |
| Art Therapy | Fatigue | T3 | 60.36 score on a scale | Standard Deviation 29.4 |
| Mandala Group | Fatigue | T1 | 63.08 score on a scale | Standard Deviation 29.69 |
| Mandala Group | Fatigue | T2 | 58.99 score on a scale | Standard Deviation 24.79 |
| Mandala Group | Fatigue | T3 | 63.21 score on a scale | Standard Deviation 28.38 |
Pain (Impact and Interference)
The PROMIS Pain impact Scale measures how much pain impacted different aspects of life in the past 7 days. Scores range from 0-to-60, higher scores indicating higher levels of pain or its impact on functioning and the PROMIS Pain Interference Scale measures how much pain interfered with different aspects of life in the past 7 days. Scores range from 0-to-60, higher scores indicating higher levels of pain or interference with functioning. Our data indicates t-scores calculated so that 50 indicates the population (cancer patient) mean with a standard deviation of 10.
Time frame: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)
Population: The overall number of participants analyzed reflects the number of participants at T1. We used the maximum likelihood analyses, thus each row reflects the actual number of participants who had full data and the respective means and standard deviations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Art Therapy | Pain (Impact and Interference) | Pain intensity T3 | 59.1 t-score | Standard Deviation 11.6 |
| Art Therapy | Pain (Impact and Interference) | Pain interference T2 | 56.7 t-score | Standard Deviation 9.43 |
| Art Therapy | Pain (Impact and Interference) | Pain interference T1 | 59.0 t-score | Standard Deviation 9.3 |
| Art Therapy | Pain (Impact and Interference) | Pain intensity T2 | 55.9 t-score | Standard Deviation 11.9 |
| Art Therapy | Pain (Impact and Interference) | Pain interference T3 | 59.0 t-score | Standard Deviation 9 |
| Art Therapy | Pain (Impact and Interference) | Pain intensity T1 | 58.74 t-score | Standard Deviation 12.5 |
| Mandala Group | Pain (Impact and Interference) | Pain interference T3 | 57.7 t-score | Standard Deviation 9.3 |
| Mandala Group | Pain (Impact and Interference) | Pain intensity T1 | 57.4 t-score | Standard Deviation 12.3 |
| Mandala Group | Pain (Impact and Interference) | Pain intensity T2 | 56.1 t-score | Standard Deviation 11.8 |
| Mandala Group | Pain (Impact and Interference) | Pain intensity T3 | 58.0 t-score | Standard Deviation 12.5 |
| Mandala Group | Pain (Impact and Interference) | Pain interference T2 | 57.1 t-score | Standard Deviation 9 |
| Mandala Group | Pain (Impact and Interference) | Pain interference T1 | 59.3 t-score | Standard Deviation 9.4 |
Acceptance of Emotions
The Acceptance of Emotions Scale assesses the extent to which subjects are accepting and nurturing toward their feelings, ranging 0-100, higher scores indicate higher acceptance of emotion.
Time frame: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)
Population: We conducted maximum likelihood analyses and the numbers here are raw scores, in which if a participant skipped one item the entire questionnaire was marked missing.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Art Therapy | Acceptance of Emotions | T1 | 67.7756 score on a scale |
| Art Therapy | Acceptance of Emotions | T2 | 66.12 score on a scale |
| Art Therapy | Acceptance of Emotions | T3 | 69.86 score on a scale |
| Mandala Group | Acceptance of Emotions | T1 | 63.8561 score on a scale |
| Mandala Group | Acceptance of Emotions | T2 | 68.42 score on a scale |
| Mandala Group | Acceptance of Emotions | T3 | 71.29713424 score on a scale |
Emotional Awareness
The Levels of Emotional Awareness Scale is a written performance index of ability to express emotion in a differentiated and complex way. Subjects write about their anticipated feelings and those of another person in response to 10 short vignettes. Responses are scored on a 1 - 4 range and summed up to create a range of 0-50 according to the degree of specificity in the terms used and the range of emotions described, higher scores indicating higher levels of awareness.
Time frame: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)
Population: We used maximum likelihood for analyses. The numbers here reflect raw data, where if one question was not answered, the whole questionnaire is marked as missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Art Therapy | Emotional Awareness | T3 | 30.12 score on a scale | Standard Deviation 5.21 |
| Art Therapy | Emotional Awareness | T1 | 30.11 score on a scale | Standard Deviation 5.28 |
| Art Therapy | Emotional Awareness | T2 | 30.87 score on a scale | Standard Deviation 4.523 |
| Mandala Group | Emotional Awareness | T2 | 30.9 score on a scale | Standard Deviation 5.49 |
| Mandala Group | Emotional Awareness | T3 | 28.77 score on a scale | Standard Deviation 4.84 |
| Mandala Group | Emotional Awareness | T1 | 30.59 score on a scale | Standard Deviation 6.24 |
Emotional Expression
This is a 36-item scale in which participants respond on a Likert scale from 1 (I don't do this at all) to 4 (I do this a lot) regarding how they coped with breast cancer experiences in the past four weeks. Two subscales are created from means of items: Approach Coping composite (24 items), and Avoidance composite (12 items) each with a range from 1-4 . Higher scores indicate more approach-oriented or avoidance-oriented coping. Participants rated items on a response scale of 1 (''I don't do this at all'') to 4 (''I do this a lot'').
Time frame: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline (T2), and 8 weeks after the intervention ends (T3)
Population: We utilized maximum likelihood, and here are presented raw data, in which if a participant missed one question, the data was marked as missing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Art Therapy | Emotional Expression | Approach T3 | 3.078 score on a scale | Standard Deviation 0.48 |
| Art Therapy | Emotional Expression | Avoidance T1 | 1.99 score on a scale | Standard Deviation 0.56 |
| Art Therapy | Emotional Expression | Avoidance T3 | 2.21 score on a scale | Standard Deviation 0.67 |
| Art Therapy | Emotional Expression | Approach T1 | 3.2596 score on a scale | Standard Deviation 0.44 |
| Art Therapy | Emotional Expression | Approach T2 | 3.17 score on a scale | Standard Deviation 0.52 |
| Art Therapy | Emotional Expression | Avoidance T2 | 2.04 score on a scale | Standard Deviation 0.78 |
| Mandala Group | Emotional Expression | Avoidance T3 | 2.27 score on a scale | Standard Deviation 0.74 |
| Mandala Group | Emotional Expression | Approach T3 | 3.21 score on a scale | Standard Deviation 0.52 |
| Mandala Group | Emotional Expression | Approach T2 | 3.169312169 score on a scale | Standard Deviation 0.52 |
| Mandala Group | Emotional Expression | Avoidance T1 | 2.08 score on a scale | Standard Deviation 0.59 |
| Mandala Group | Emotional Expression | Avoidance T2 | 2.18 score on a scale | Standard Deviation 0.7 |
| Mandala Group | Emotional Expression | Approach T1 | 3.185 score on a scale | Standard Deviation 0.54 |
Heart Rate Variability
20 minutes of resting ECG data will be recorded. The participants will be given instructions not to drink coffee or smoke for 3 hours before the lab visit as well as to sit quietly without talking or moving during the ECG recording. These are physiological data without a specific range, however in our study, for example, at T1 in the art therapy group the measurements ranged from 7.56 to 113.28 miliseconds.
Time frame: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline, T2) and 8 weeks after the intervention ends (T3)
Population: Each row represents the actual number of participants we were able to collect EKG and obtain a good signal, and data was not discarded because of too much noise, or reporting drinking coffee before the measurement,
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Art Therapy | Heart Rate Variability | T1 | 32.63 miliseconds | Standard Deviation 21.8 |
| Art Therapy | Heart Rate Variability | T2 | 33.13 miliseconds | Standard Deviation 20.21 |
| Art Therapy | Heart Rate Variability | T3 | 35.22226363 miliseconds | Standard Deviation 40.4 |
| Mandala Group | Heart Rate Variability | T1 | 37.82 miliseconds | Standard Deviation 38.8 |
| Mandala Group | Heart Rate Variability | T2 | 31.89 miliseconds | Standard Deviation 20.7 |
| Mandala Group | Heart Rate Variability | T3 | 33.58334362 miliseconds | Standard Deviation 25.6 |
Inflammation
We collected 10 ccs of blood in order to measure immune regulation (pro-inflammatory cytokines IL-6, IL-8, IL-1β, TNF-α), anti-inflammatory (IL-4, IL-10) and regulatory cytokines (TGF-β).
Time frame: Changes will be measured from baseline (T1), after the intervention, 8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3).
Population: Number in each row reflect the number of results obtain for each cytokine at each time point. The overall number analyzed reflects the largest number of individuals that provided blood that was able to produce a quantification of at least one cytokine.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Art Therapy | Inflammation | il_4_T3 | 11.2 pcg/ml | Standard Deviation 35.7 |
| Art Therapy | Inflammation | IL-8 T2 | 11.02 pcg/ml | Standard Deviation 10.65 |
| Art Therapy | Inflammation | il_6_T1 | 1.4 pcg/ml | Standard Deviation 3.1 |
| Art Therapy | Inflammation | il_1b_T2 | 0.18 pcg/ml | Standard Deviation 0.312 |
| Art Therapy | Inflammation | il_6_T2 | 0.75 pcg/ml | Standard Deviation 1.58 |
| Art Therapy | Inflammation | tnfa_T2 | 8.007 pcg/ml | Standard Deviation 4.8 |
| Art Therapy | Inflammation | il_6_T3 | 0.68 pcg/ml | Standard Deviation 1.62 |
| Art Therapy | Inflammation | il_1b_T3 | 0.2632 pcg/ml | Standard Deviation 0.77 |
| Art Therapy | Inflammation | tnfa_T1 | 10.85 pcg/ml | Standard Deviation 15.36 |
| Art Therapy | Inflammation | il_10_T1 | 0.43 pcg/ml | Standard Deviation 1.3 |
| Art Therapy | Inflammation | IL-8 T3 | 9.0135 pcg/ml | Standard Deviation 7.725 |
| Art Therapy | Inflammation | il_10_T2 | 0.19 pcg/ml | Standard Deviation 0.43 |
| Art Therapy | Inflammation | il_4_T1 | 16.8 pcg/ml | Standard Deviation 31.6 |
| Art Therapy | Inflammation | il_10_T3 | 0.34 pcg/ml | Standard Deviation 0.99 |
| Art Therapy | Inflammation | tnfa_T3 | 7.56 pcg/ml | Standard Deviation 10.68 |
| Art Therapy | Inflammation | tgf_b1_T1 | 51085 pcg/ml | Standard Deviation 32095 |
| Art Therapy | Inflammation | il_4_T2 | 10.1 pcg/ml | Standard Deviation 17.53 |
| Art Therapy | Inflammation | tgf_b1_T2 | 48885 pcg/ml | Standard Deviation 22571 |
| Art Therapy | Inflammation | il_1b_T1 | 0.42 pcg/ml | Standard Deviation 1.15 |
| Art Therapy | Inflammation | tgf_b1_T3 | 51447 pcg/ml | Standard Deviation 34759 |
| Art Therapy | Inflammation | IL-8 T1 | 15.78 pcg/ml | Standard Deviation 24.3 |
| Mandala Group | Inflammation | tgf_b1_T3 | 48178 pcg/ml | Standard Deviation 23994 |
| Mandala Group | Inflammation | tnfa_T1 | 14.27 pcg/ml | Standard Deviation 23.07 |
| Mandala Group | Inflammation | tnfa_T2 | 9.64 pcg/ml | Standard Deviation 11.98 |
| Mandala Group | Inflammation | tnfa_T3 | 10.04 pcg/ml | Standard Deviation 14.49 |
| Mandala Group | Inflammation | IL-8 T1 | 22.1597 pcg/ml | Standard Deviation 55.01 |
| Mandala Group | Inflammation | IL-8 T2 | 11.84 pcg/ml | Standard Deviation 11.9 |
| Mandala Group | Inflammation | IL-8 T3 | 9.278 pcg/ml | Standard Deviation 9.38 |
| Mandala Group | Inflammation | il_1b_T1 | 0.55 pcg/ml | Standard Deviation 1.37 |
| Mandala Group | Inflammation | il_1b_T2 | 0.227 pcg/ml | Standard Deviation 0.5 |
| Mandala Group | Inflammation | il_1b_T3 | 0.234 pcg/ml | Standard Deviation 0.68 |
| Mandala Group | Inflammation | il_4_T1 | 24.33 pcg/ml | Standard Deviation 50.3 |
| Mandala Group | Inflammation | il_4_T2 | 12.7 pcg/ml | Standard Deviation 23.09 |
| Mandala Group | Inflammation | il_4_T3 | 14.58 pcg/ml | Standard Deviation 40.49 |
| Mandala Group | Inflammation | il_6_T1 | 1.52 pcg/ml | Standard Deviation 3.1 |
| Mandala Group | Inflammation | il_6_T2 | 0.9 pcg/ml | Standard Deviation 1.97 |
| Mandala Group | Inflammation | il_6_T3 | 1.48 pcg/ml | Standard Deviation 4.11 |
| Mandala Group | Inflammation | il_10_T1 | 0.65 pcg/ml | Standard Deviation 2.04 |
| Mandala Group | Inflammation | il_10_T2 | 0.53 pcg/ml | Standard Deviation 1.44 |
| Mandala Group | Inflammation | il_10_T3 | 0.718 pcg/ml | Standard Deviation 2.36 |
| Mandala Group | Inflammation | tgf_b1_T1 | 51016 pcg/ml | Standard Deviation 31641 |
| Mandala Group | Inflammation | tgf_b1_T2 | 47819 pcg/ml | Standard Deviation 25255 |