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NCT07143461 | RECRUITING | Migraine


The Effects of Prayer on Pain Thresholds and Scores of Anxiety and Depression in Patients With Migraine and Control
Sponsor:

Georgia Kleinschmitt Westenhofen

Information provided by (Responsible Party):

Georgia Kleinschmitt Westenhofen

Brief Summary:

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: 55 participants. Non-migraine group: 55 participants. Number of participants in total: 110.

Condition or disease

Migraine

Intervention/treatment

Faith Healing

Control

Phase

NA

Detailed Description:

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 110 participants
Masking : DOUBLE
Masking Description : The researcher will not know which intervention was performed on the first and last day until the study is completed. Randomization will be conducted using two envelopes, each containing the description of one of the two interventions: prayer or reading the control text for 10 minutes. During the first assessment, the envelope chosen by the participant will indicate the procedure to be performed. During the second assessment (follow-up), the remaining intervention (the one not performed on the first day) will be conducted.
Primary Purpose : TREATMENT
Official Title : The Effects of Prayer on Pain Thresholds and Scores of Anxiety and Depression in Patients With Migraine and Control: a Randomized Clinical Trial
Actual Study Start Date : 2023-09-29
Estimated Primary Completion Date : 2025-09-29
Estimated Study Completion Date : 2025-12-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 60 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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.

The Effects of Prayer on Pain Thresholds and Scores of Anxiety and Depression in Patients With Migraine and Control

Location Details

NCT07143461


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Locations


RECRUITING

Brazil, São Paulo

Institute of Psychiatry of the University of São Paulo

São Paulo, São Paulo, Brazil, 05403-903

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