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

NCT ID: NCT07143461

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-29

Study Completion Date

2025-09-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Single-blind, randomized crossover trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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Migraine + prayer

Each migraine participant will serve as their own control, meaning they will undergo both the prayer intervention and the control text intervention on different days. This arm is for the migraine participant and the prayer intervention.

Group Type EXPERIMENTAL

Faith Healing

Intervention Type BEHAVIORAL

In the prayer condition, the participants will engage and vocalize in prayers they are already familiar with and commonly practice at least once, then continue silently for 10 minutes, focusing on the content. If distracted, participants should refocus on the prayer and reflect on its meaning.

Migraine + control text reading

Each migraine participant will serve as their own control, meaning they will undergo both the prayer intervention and the control text intervention on different days. This arm is for the migraine participant and the control text reading intervention.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

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.

Non-migraine + prayer

Each non-migraine participant will serve as their own control, meaning they will undergo both the prayer intervention and the control text intervention on different days. This arm is for the migraine participant and the prayer intervention.

Group Type EXPERIMENTAL

Faith Healing

Intervention Type BEHAVIORAL

In the prayer condition, the participants will engage and vocalize in prayers they are already familiar with and commonly practice at least once, then continue silently for 10 minutes, focusing on the content. If distracted, participants should refocus on the prayer and reflect on its meaning.

Non-migraine + control text reading

Each non-migraine participant will serve as their own control, meaning they will undergo both the prayer intervention and the control text intervention on different days. This arm is for the migraine participant and the control text reading intervention.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

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.

Interventions

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Faith Healing

In the prayer condition, the participants will engage and vocalize in prayers they are already familiar with and commonly practice at least once, then continue silently for 10 minutes, focusing on the content. If distracted, participants should refocus on the prayer and reflect on its meaning.

Intervention Type BEHAVIORAL

Control

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Georgia Kleinschmitt Westenhofen

Sub-Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute of Psychiatry of the University of São Paulo

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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U1111-1316-9878

Identifier Type: -

Identifier Source: org_study_id

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