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

U

University of Sao Paulo

Status

Completed

Conditions

Migraine

Treatments

Behavioral: Control
Behavioral: Faith Healing

Study type

Interventional

Funder types

Other

Identifiers

NCT07143461
U1111-1316-9878

Details and patient eligibility

About

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.

Full 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.

Enrollment

105 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

105 participants in 4 patient groups

Migraine + prayer
Experimental group
Description:
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.
Treatment:
Behavioral: Faith Healing
Migraine + control text reading
Active Comparator group
Description:
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.
Treatment:
Behavioral: Control
Non-migraine + prayer
Experimental group
Description:
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.
Treatment:
Behavioral: Faith Healing
Non-migraine + control text reading
Active Comparator group
Description:
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.
Treatment:
Behavioral: Control

Trial contacts and locations

1

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Central trial contact

Georgia Kleinschmitt Westenhofen, MSc

Data sourced from clinicaltrials.gov

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