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This study is a double-blinded randomized controlled trial with two arms, comparing a recorded mindfulness intervention to a control psycho-education audio. It is a monocentric study that will take place in Centre Hospitalier Universitaire Vaudois (CHUV), a primary teaching hospital in Lausanne, Switzerland.
Patients will be randomized 1:1 to the brief mindfulness intervention vs neutral audio intervention. The investigators involved in recruitment and testing will be blind to the intervention condition. A collaborator that is not involved in this study will prepare a coded randomized sequence of audio assignments, uploaded in Redcap. The audio will be played on a laptop or mp-player with a noise cancelling headset.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness | Experimental |
| |
| Psycho-education | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness | Behavioral | One session of a 20 minute mindfulness recording, based on standardised script, focused on stress management. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perceived stress reactivity | The primary outcome is the variation of perceived stress level along the task. A 2-way repeated-measures ANOVA will be conducted to compare the stress reactivity of patients receiving the mindfulness intervention and the control intervention. Perceived stress will be measured using visual analog scales from 0 to 10, 0 meaning no stress perceived and 10 meaning the highest stress perceived. | Within 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability | Heart rate variability will also be measured using a NeXus-10 MKII, Mindmedia with 3 electrodes. A 2-way repeated-measures ANOVA will be conducted to compare the heart rate variability of patients receiving the mindfulness intervention and the control intervention. | Within 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chantal Berna, Prof | Centre de médecine intégrative et complémentaire, CHUV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Médecine Intégrative et Complémentaire, CHUV | Lausanne | Canton of Vaud | 1011 | Switzerland |
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| Psycho-education | Behavioral | One session of a 20 minute recording, based on standardised script, focused on psychophysiological stress response description. |
|
| Respiration rate |
Respiration rate will also be measured using a NeXus-10 MKII, Mindmedia with a thoracic belt. A 2-way repeated-measures ANOVA will be conducted to compare the respiration rate of patients receiving the mindfulness intervention and the control intervention. |
| Within 3 hours |
| Oxygen saturation | Oxygen saturation will also be measured using a NeXus-10 MKII, Mindmedia with a pulse oximeter probe. A 2-way repeated-measures ANOVA will be conducted to compare the oxygen saturation of patients receiving the mindfulness intervention and the control intervention. | Within 3 hours |
| Electrodermal activity | Electrodermal activity will also be measured using a NeXus-10 MKII, Mindmedia with two fingertips electrodes. A 2-way repeated-measures ANOVA will be conducted to compare the electrodermal activity of patients receiving the mindfulness intervention and the control intervention. | Within 3 hours |
| Cerebral activity | Cerebral activity will also be measured using a 6-electrodes headband electroencephalogram (Dreem headband, Dreem SAS). | Within 3 hours |
| Salivary cortisol concentrations | Salivary cortisol concentration will also be collected using a mouth cotton swab. A 2-way repeated-measures ANOVA will be conducted to compare the salivary cortisol concentrations of patients receiving the mindfulness intervention and the control intervention. | Within 3 hours |
| Blood catecholamine levels | Blood catecholamine levels will also be collected using a venous line on the non-dominant arm for repeated blood collection. A 2-way repeated-measures ANOVA will be conducted to compare the blood catecholamine levels of patients receiving the mindfulness intervention and the control intervention. | Within 3 hours |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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