RecruitingACTRN12624000611527

Effect of a Mindfulness program on patients with Tension Headache and chronic Migraine

A randomised controlled trial investigating the effects of a program based on relaxation and concentration exercises through a telematic application on symptom frequency in patients with tension headache and chronic migraine.


Sponsor

University European of Madrid

Enrollment

40 participants

Start Date

Feb 6, 2024

Study Type

Interventional

Conditions

Summary

Migraine is a global health issue, ranking sixth in prevalence according to the 2016 Global Burden Disease. Mindfulness stands out as an effective therapeutic approach to reduce psychological symptoms associated with chronic pain, with studies indicating physical and psychological benefits. Affective/cognitive factors play a crucial role in chronic migraine, and mindfulness can positively modulate them. Although interventions are typically in-person, mobile applications like Petit BamBou provide mindfulness programs with educational content. Telematic interventions have also proven effective in reducing variables associated with chronic pain.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria3

  • Patients with a medical diagnosis of Migraine according to the criteria of the Third edition of the international classification of Headaches
  • Men or Women between 18 and 65 years old
  • Subjects who have mobile devices such as Smartphones.

Exclusion Criteria2

  • Hearing problems that prevent the correct execution of the exercises
  • Participation during the duration of the study in other clinical trials

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Interventions

Subjects assigned to the intervention group will be contacted by telephone or email to give them instructions on downloading the “Petit BamBou” mobile application (www.petitbambou.com) to their electr

Subjects assigned to the intervention group will be contacted by telephone or email to give them instructions on downloading the “Petit BamBou” mobile application (www.petitbambou.com) to their electronic devices. Once this procedure is completed, you will be provided with a free access code to the platform for a period of 2 months. Once they have access to the application, they would be asked to listen to and follow the “Meditation of the day” instructions provided by the application for 2 non-consecutive days a week, which is different each day. Minfulness App; The patient will be guided to focus on their breathing through a guided meditation using the Petit Bamboo ® meditation app. The 6/6 breathing will be used, 6 seconds for inspiration, 6 seconds for expiration. In order for the participants to concentrate on the audios by focusing their attention on them, they will be asked to remain seated, in silence, in a quiet place without noise. The inductions to mindfulness will consist of focusing attention on breathing and awareness in the present moment by focusing on the sensations of incoming and outgoing air, trying to concentrate on breathing movements without thinking, guided and recorded by professionals of mindfulness in Spanish using the audios of the app. The procedure is based on the studies of Huberty and Wells. The study variables will be measured at 2 moments: just before the start of the study and immediately after it (8 weeks); The evaluations will be carried out by self-completing the surveys in online format (Microsoft Forms) that will be sent to each participant by email.


Locations(1)

Madrid, Spain

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ACTRN12624000611527