Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000611527
Ethics application status
Approved
Date submitted
5/03/2024
Date registered
10/05/2024
Date last updated
10/05/2024
Date data sharing statement initially provided
10/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of a Mindfulness program on patients with Tension Headache and chronic Migraine
Scientific title
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.
Secondary ID [1] 311672 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tension headache 333132 0
Chronic migraine 333412 0
Condition category
Condition code
Neurological 329829 329829 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 328136 0
Lifestyle
Comparator / control treatment
The waiting list control group will continue with their basic medical treatment (anti-inflammatories in episodes of high pain, and/or preventive medication; triptans), not performing the meditation intervention.

And once the study ends, they will also be provided with free access codes to the application for 2 months, so that they can enjoy it in the same way, but their measures will be as a control prior to access to the app.
Control group
Active

Outcomes
Primary outcome [1] 337597 0

The headache frequency questionnaires will be sent through a Microsoft Forms account created for this purpose..
Timepoint [1] 337597 0
Baseline and immediately following the end of the 8-week intervention program.
Secondary outcome [1] 433448 0
Headache Impact on daily activities
Timepoint [1] 433448 0
Baseline and immediately following the end of the 8-week intervention program.
Secondary outcome [2] 433449 0
Anxiety severity
Timepoint [2] 433449 0
Baseline and immediately following the end of the 8-week intervention program.
Secondary outcome [3] 433450 0
Fear of pain
Timepoint [3] 433450 0
Baseline and immediately following the end of the 8-week intervention program.
Secondary outcome [4] 433451 0
Sleep quality
Timepoint [4] 433451 0
Baseline and immediately following the end of the 8-week intervention program.
Secondary outcome [5] 433452 0
Daily physical activity rate
Timepoint [5] 433452 0
Baseline and immediately following the end of the 8-week intervention program.

Eligibility
Key inclusion criteria
The inclusion criteria are:

-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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

-Hearing problems that prevent the correct execution of the exercises

-Participation during the duration of the study in other clinical trials

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
6/02/2024
Date of last participant enrolment
Anticipated
1/06/2024
Actual
Date of last data collection
Anticipated
19/07/2024
Actual
Sample size
Target
40
Accrual to date
16
Final
Recruitment outside Australia
Country [1] 26189 0
Spain
State/province [1] 26189 0
Madrid

Funding & Sponsors
Funding source category [1] 315999 0
University
Name [1] 315999 0
University European of Madrid
Country [1] 315999 0
Spain
Primary sponsor type
University
Name
University European of Madrid
Address
Country
Spain
Secondary sponsor category [1] 318151 0
None
Name [1] 318151 0
Address [1] 318151 0
Country [1] 318151 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314825 0
Ethics Committee of the Rey Juan Carlos Hospital
Ethics committee address [1] 314825 0
'Rey Juan Carlos University Hospital, C. Gladiolo, s/n, 28933 Móstoles, Madrid, Spain'.
Ethics committee country [1] 314825 0
Spain
Date submitted for ethics approval [1] 314825 0
19/10/2023
Approval date [1] 314825 0
15/12/2023
Ethics approval number [1] 314825 0

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132842 0
Dr Diego Domínguez-Balmaseda
Address 132842 0
Universidad Europea de Madrid, Calle Tajo s/n, Villaviciosa de Odón, Madrid, España. CP: 28005
Country 132842 0
Spain
Phone 132842 0
+34617745364
Fax 132842 0
Email 132842 0
diego.dominguez@universidadeuropea.es
Contact person for public queries
Name 132843 0
Guillermo García de Sevilla Perez
Address 132843 0
Universidad Europea de Madrid, Calle Tajo s/n, Villaviciosa de Odón, Madrid, España. CP: 28005
Country 132843 0
Spain
Phone 132843 0
+34617745364
Fax 132843 0
Email 132843 0
guillermo.garcia@universidadeuropea.es
Contact person for scientific queries
Name 132844 0
Angel Gonzalez de la Flor
Address 132844 0
Universidad Europea de Madrid, Calle Tajo s/n, Villaviciosa de Odón, Madrid, España. CP: 28005
Country 132844 0
Spain
Phone 132844 0
+34617745364
Fax 132844 0
Email 132844 0
angel.gonzalez@univerisdadeuropea.es

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21807Informed consent form  diego.dominguez@universidadeuropea.es 387446-(Uploaded-01-04-2024-21-41-07)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.