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

NCT07143461 | Completed

• 1 other identifier: U1111-1316-9878
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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: 50 participants. Non-migraine group: 50 participants. Total number of participants in total: 100.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Prayer and pressure pain threshold in Kilopascal (kPa)

  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).

  Immediately after the intervention session

Secondary Outcomes (4)

• Spirituality scores using the Functional Assessment of Chronic Illness Therapy - Spiritual Well-being (FACIT-Sp) scale

  Immediately after the intervention session

• Level of religiosity using the Duke Religious Index (DUREL)

  Immediately after the intervention session

• Anxiety Variables using Generalized Anxiety Disorder Screener (GAD-7 Scale)

  Immediately after the intervention session

• Depression Variables - Patient Health Questionnaire (PHQ-9 Scale)

  Immediately after the intervention session

Other Outcomes (1)

• Different aspects of prayer on the pressure pain threshold in Kilopascal (kPa)

  Immediately after the intervention session

Study Arms (4)

Migraine + prayer

EXPERIMENTAL

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.

Behavioral: Faith Healing

Migraine + control text reading

ACTIVE COMPARATOR

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.

Behavioral: Control

Non-migraine + prayer

EXPERIMENTAL

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.

Behavioral: Faith Healing

Non-migraine + control text reading

ACTIVE COMPARATOR

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.

Behavioral: Control

Interventions

Faith Healing BEHAVIORAL

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.

Migraine + prayer; Non-migraine + prayer

Control 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.

Migraine + control text reading; Non-migraine + control text reading

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of chronic or episodic migraine.
• Feeling comfortable performing a known prayer.

You may not qualify if:

• Severe acute circulatory disorders
• Decompensated diabetes mellitus
• Cognitive weaknesses that prevent the patient from understanding and carrying out the study procedures.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Institute of Psychiatry of the University of São Paulo

São Paulo, São Paulo, 05403-903, Brazil

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Faith Healing

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Spiritual Therapies; Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sub-Investigator

Model Details: Single-blind, randomized crossover trial

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: August 27, 2025
• Study Start: September 29, 2023
• Primary Completion: September 29, 2025
• Study Completion: September 29, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)