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Completed

NCT Number: NCT05568030

Evaluation of the Efficacy of a Single Brief Intervention of Mindfulness to Reduce Stress Response in a Social Stress Task Paradigm

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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Key information

Conditions

Mindfulness Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases Stress

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Médecine Intégrative et Complémentaire, CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • We plan to recruit adult female patients (>18 years old) suffering from fibromyalgia (FMS), with chronic pain (more than 6 months), willing and able to give informed consent. Specifically, patients must fulfil the criteria of the American College of Rheumatology (2010) by having the following combination of scores at the widespread pain index (WPI) and the severity score (SS) :
  • WPI score is ≥7 and the SS score is ≥ 5 OR
  • WPI score is comprised between 3 to 6 and the SS score ≥9
  • And no other condition explaining the painful syndrome

Exclusion criteria

  • Insufficient French language skills
  • Unstable psychiatric co-morbidity: major depression with current suicidal risk, unstable psychotic disorder, unstable psychotropic medication (stable=more than 3 month under the same dose).
  • Somatic co-morbidity that could interfere with physiological monitoring/stress tolerance: such as cardiac malformation, recent myocardial dysfunction, cardiac transplantation, or cardiac treatment (pacemaker, antiarrhythmic drugs, muscarinic receptor blockers, ACE inhibitors or any that would induce a modification in HR)
  • Contraindication to sensors positioning (local skin damage or allergies)
  • Substance use disorder (alcohol, drugs).
  • Refusal to listen to an audio recording of mindfulness

Treatment and study plan

Mindfulness

Behavioral

One session of a 20 minute mindfulness recording, based on standardised script, focused on stress management.

Psycho-education

Behavioral

One session of a 20 minute recording, based on standardised script, focused on psychophysiological stress response description.

Primary outcomes

  1. Perceived stress reactivity

    Time frame: Within 3 hours

    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.

Secondary outcomes

  1. Heart rate variability

    Time frame: Within 3 hours

    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.

  2. Respiration rate

    Time frame: Within 3 hours

    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.

  3. Oxygen saturation

    Time frame: Within 3 hours

    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.

  4. Electrodermal activity

    Time frame: Within 3 hours

    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.

  5. Cerebral activity

    Time frame: Within 3 hours

    Cerebral activity will also be measured using a 6-electrodes headband electroencephalogram (Dreem headband, Dreem SAS).

  6. Salivary cortisol concentrations

    Time frame: Within 3 hours

    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.

  7. Blood catecholamine levels

    Time frame: Within 3 hours

    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.

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Registry information

Acronym: SBST_FMS

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 5, 2022
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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