Institute of Psychiatry of the University of São Paulo
São Paulo, 05403-903, Brazil
NCT Number: NCT07143461
The objective of this randomized single-blind crossover study is to evaluate the effect of prayer compared to the practice of reading a text (control) on the pressure pain threshold in individuals with and without migraine. The main topics it aims to answer are:
* To analyze the relationship between individuals' spirituality, pain thresholds, and anxiety and depression scores. * To evaluate the effects of different aspects of prayer (thanksgiving, adoration, confession, meditative, and petitionary) on cephalic pain thresholds in individuals with and without migraines.
Migraine group: 50 participants. Non-migraine group: 50 participants. Total number of participants in total: 100.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
São Paulo, 05403-903, Brazil
Pressure pain thresholds (PPT) represent each person's sensitivity, where the pressure is gradually increased, and participants report when the applied pressure changes from a sensation of pressure to a sensation of pressure and pain. The NOD device is equipped with a digital algometry function, providing reliable quantification of the pressure pain threshold for each individual. For proper use, a 1 cm² adapter will be attached to the front of the device. The tip of this adapter will be positioned perpendicularly to the anatomical structures to be assessed: the temporal region, frontal region, occipital nerve, and vertex. Pain threshold, defined as the minimum pressure required to provoke pain, will be measured in Kg/cm².
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will perform a 10-minute session of silent personal prayer using a prayer they are already familiar with and commonly practice. Participants will be instructed to pray in their usual way without vocalization, focusing on the content/meaning of the prayer. If distracted, they will be asked to gently refocus on prayer.
In the control condition, participants will read a neutral text with no spiritual or religious content for 10 minutes. If distracted, they should refocus on the text.
Time frame: Immediately after the intervention session
To evaluate the effect of prayer compared to the practice of reading a text (control) on the pressure pain threshold in kilopascal unit (kPa) in individuals with and without migraine. To assess the pressure pain threshold, a digital algometer will be used, which measures pain tolerance in kilopascals (kPa).
Time frame: Immediately after the intervention session
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.
Time frame: Immediately after the intervention session
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.
Time frame: Immediately after the intervention session
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).
Time frame: Immediately after the intervention session
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.
Time frame: Immediately after the intervention session
To evaluate the effects of different aspects of prayer (thanksgiving, adoration, confession, meditative, and petitionary) on cephalic pressure pain thresholds in individuals with and without migraines. To assess the pressure pain threshold, a digital algometer will be used, which measures pain tolerance in kilopascals (kPa).
University of Sao Paulo
Other
The Effects of Prayer on Pain Thresholds and Scores of Anxiety and Depression in Patients With Migraine and Control: a Randomized Clinical Trial
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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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