Migraine
Conditions
Brief summary
This study comprised two separate assessor-blinded randomized crossover experiments, one in participants with migraine and one in participants without migraine. Within each cohort, participants completed two experimental conditions on separate study visits: 10 minutes of self-selected personal prayer and 10 minutes of non-spiritual reading. The order of the two conditions was randomized within each cohort. The primary outcome was cephalic pressure pain threshold (PPT), assessed immediately before and after each experimental condition at eight craniofacial sites. The study examined acute changes in PPT following prayer and reading. Spiritual well-being, religiosity, anxiety symptoms, and depressive symptoms were assessed once at baseline to characterize the participants and were not repeated following the experimental conditions. A total of 109 participants were enrolled: 57 participants with migraine and 52 participants without migraine.
Detailed description
Pressure pain threshold (PPT) was assessed using a digital hand-held algometer. Pressure was progressively applied to eight craniofacial sites, and participants indicated the point at which the pressure sensation first became painful. Measurements were expressed in kilopascals (kPa). The eight-site assessment was used to characterize cephalic pressure pain sensitivity across multiple craniofacial regions rather than relying on a single measurement site.
Interventions
BEHAVIORALPrayer Condition
Participants performed a 10-minute session of silent personal prayer using a prayer they were already familiar with and commonly practiced. Participants were instructed to pray in their usual way without vocalization, focusing on the content/meaning of the prayer. If distracted, they were asked to gently refocus on prayer.
BEHAVIORALReading Condition
In the reading condition, participants read a non-spiritual text with no spiritual or religious content for 10 minutes. If distracted, they were instructed to refocus on the text.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessor remained unaware of the experimental condition performed during each study visit. After the pre-intervention PPT assessment, the assessor left the room before the participant opened the sealed envelope and returned after the experimental condition had been completed. Participants were necessarily aware of whether they were praying or reading.
Intervention model description
Two separate assessor-blinded randomized crossover experiments, one in participants with migraine and one in participants without migraine. Within each cohort, participants received both experimental conditions in a randomized order.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis of chronic or episodic migraine. * Feeling comfortable performing a known prayer.
Exclusion criteria
* Severe acute circulatory disorders * Decompensated diabetes mellitus * Cognitive weaknesses that prevent the patient from understanding and carrying out the study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Cephalic Pressure Pain Threshold (PPT) | Immediately before and immediately after each experimental condition | Cephalic pressure pain threshold (PPT) was assessed using a digital algometer at eight craniofacial sites. The primary outcome was the total cephalic PPT, calculated as the sum of the eight site-specific PPT measurements and expressed in kilopascals (kPa). Higher values indicate a higher pressure pain threshold. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spirituality scores using the Functional Assessment of Chronic Illness Therapy - Spiritual Well-being (FACIT-Sp) scale | Baseline, before the experimental conditions | The FACIT-Sp scale assesses the spiritual well-being of volunteers, focusing on the existential aspects of spirituality and faith. It consists of 12 statements, which are rated on a scale ranging from "not at all," "a little," "somewhat," "quite a bit," to "very much." Higher scores indicate a higher level of spirituality. This assessment does not presuppose belief in God, and therefore does not limit the ability of atheists and agnostics to respond. |
| Level of religiosity using the Duke Religious Index (DUREL) | Baseline, before the experimental conditions | To collect data on religiosity, the Duke Religious Index (DUREL) was used to assess the participants' religious involvement. The scale includes five items that address three dimensions of religiosity directly related to health outcomes: organizational religious activity (ORA), non-organizational religious activity (NORA), and intrinsic religiosity (IR). In the validated Portuguese version, lower scores indicate higher levels of religiosity. |
| Anxiety Variables using Generalized Anxiety Disorder Screener (GAD-7 Scale) | Baseline, before the experimental conditions | The Generalized Anxiety Disorder Screener (GAD-7) is a 7-item tool based on DSM-IV criteria. It is a unidimensional and easy-to-administer scale designed to assess the presence of generalized anxiety disorder (GAD) symptoms. Each of the 7 items is scored from 0 (not at all) to 3 (nearly every day), resulting in a total score ranging from 0 to 21. The scores are categorized into four severity levels: minimal/no anxiety (0-4), mild (5-9), moderate (10-14), and severe (15-21). |
| Depression Variables - Patient Health Questionnaire (PHQ-9 Scale) | Baseline, before the experimental conditions | To identify individuals at risk of depression there is the Patient Health Questionnaire-9 (PHQ-9), a scale based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). It consists of nine items that assess different symptoms. The frequency of each symptom over the past two weeks is rated on a Likert scale from 0 to 3, corresponding to the responses "not at all," "several days," "more than half the days," and "nearly every day," respectively. The higher the score, the greater the levels of depressive symptoms. |
Countries
Brazil
Outcome results
None listed