MigraineNCT07143461
Effects of Prayer on Pain Thresholds and Scores of Anxiety and Depression in Participants With and Without Migraine
A study testing Prayer Condition and Reading Condition in people with Migraine, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This study comprised two separate assessor-blinded randomized crossover experiments, one in participants with migraine and one in participants without migraine. Within each cohort, participants completed two experimental conditions on separate study visits: 10 minutes of self-selected personal prayer and 10 minutes of… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- Prayer Condition and Reading Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteBrazil
- Study dates
- 29 Sep 2023to 29 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis of chronic or episodic migraine.
- Feeling comfortable performing a known prayer.
Who cannot join
- Severe acute circulatory disorders
- Decompensated diabetes mellitus
- Cognitive weaknesses that prevent the patient from understanding and carrying out the study procedures.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Institute of Psychiatry of the University of São Paulo
São Paulo, São Paulo, 05403-903
About this study
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
This study comprised two separate assessor-blinded randomized crossover experiments, one in participants with migraine and one in participants without migraine. Within each cohort, participants completed two experimental conditions on separate study visits: 10 minutes of self-selected personal prayer and 10 minutes of non-spiritual reading. The order of the two conditions was randomized within each cohort.
The primary outcome was cephalic pressure pain threshold (PPT), assessed immediately before and after each experimental condition at eight craniofacial sites. The study examined acute changes in PPT following prayer and reading. Spiritual well-being, religiosity, anxiety symptoms, and depressive symptoms were assessed once at baseline to characterize the participants and were not repeated following the experimental conditions.
A total of 109 participants were enrolled: 57 participants with migraine and 52 participants without migraine.
Read the detailed description
Pressure pain threshold (PPT) was assessed using a digital hand-held algometer. Pressure was progressively applied to eight craniofacial sites, and participants indicated the point at which the pressure sensation first became painful. Measurements were expressed in kilopascals (kPa). The eight-site assessment was used to characterize cephalic pressure pain sensitivity across multiple craniofacial regions rather than relying on a single measurement site.
- Conditions
- Migraine
- Being tested
- Prayer Condition, Reading Condition
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prayer ConditionBehavioural
Participants performed a 10-minute session of silent personal prayer using a prayer they were already familiar with and commonly practiced. Participants were instructed to pray in their usual way without vocalization, focusing on the content/meaning of the prayer. If distracted, they were asked to gently refocus on prayer.
Reading ConditionBehavioural
In the reading condition, participants read a non-spiritual text with no spiritual or religious content for 10 minutes. If distracted, they were instructed to refocus on the text.
| Study group | Role | What they receive |
|---|---|---|
| Migraine: Prayer First | Experimental | Participants with migraine randomized to the prayer-first sequence received the prayer condition at the first study visit and the non-spiritual reading condition at the second study visit. Receives: Behavioral: Prayer Condition; Behavioral: Reading Condition |
| Migraine: Reading First | Experimental | Participants with migraine randomized to the reading-first sequence received the non-spiritual reading condition at the first study visit and the prayer condition at the second study visit. Receives: Behavioral: Prayer Condition; Behavioral: Reading Condition |
| Non-Migraine: Prayer First | Experimental | Participants without migraine randomized to the prayer-first sequence received the prayer condition at the first study visit and the non-spiritual reading condition at the second study visit. Receives: Behavioral: Prayer Condition; Behavioral: Reading Condition |
| Non-Migraine: Reading First | Experimental | Participants without migraine randomized to the reading-first sequence received the non-spiritual reading condition at the first study visit and the prayer condition at the second study visit. Receives: Behavioral: Prayer Condition; Behavioral: Reading Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Cephalic Pressure Pain Threshold (PPT)
Cephalic pressure pain threshold (PPT) was assessed using a digital algometer at eight craniofacial sites. The primary outcome was the total cephalic PPT, calculated as the sum of the eight site-specific PPT measurements and expressed in kilopascals (kPa). Higher values indicate a higher pressure pain threshold.
Measured: Immediately before and immediately after each experimental condition
Secondary outcomes (4)
Spirituality scores using the Functional Assessment of Chronic Illness Therapy - Spiritual Well-being (FACIT-Sp) scale
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.
Measured: Baseline, before the experimental conditions
Level of religiosity using the Duke Religious Index (DUREL)
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.
Measured: Baseline, before the experimental conditions
Anxiety Variables using Generalized Anxiety Disorder Screener (GAD-7 Scale)
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).
Measured: Baseline, before the experimental conditions
Depression Variables - Patient Health Questionnaire (PHQ-9 Scale)
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.
Measured: Baseline, before the experimental conditions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start29 Sep 2023
- Primary completion29 Sep 2025
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two separate assessor-blinded randomized crossover experiments, one in participants with migraine and one in participants without migraine. Within each cohort, participants received both experimental conditions in a randomized order.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgia Kleinschmitt Westenhofen, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143461
- Sponsor's protocol ID
- U1111-1316-9878
- Status last verified
- Aug 2026
- First submitted
- 1 Jul 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07143461
- Acronym / sponsor ID
- U1111-1316-9878
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study comprised two separate assessor-blinded randomized crossover experiments, one in participants with migraine and one in participants without migraine. Within each cohort, participants completed two experimental conditions on separate study visits: 10 minutes of self-selected personal prayer and 10 minutes of non-spiritual reading. The order of the two conditions was randomized within each cohort.
The primary outcome was cephalic pressure pain threshold (PPT), assessed immediately before and after each experimental condition at eight craniofacial sites. The study examined acute changes in PPT following prayer and reading. Spiritual well-being, religiosity, anxiety symptoms, and depressive symptoms were assessed once at baseline to characterize the participants and were not repeated following the experimental conditions.
A total of 109 participants were enrolled: 57 participants with migraine and 52 participants without migraine.
Detailed description
Pressure pain threshold (PPT) was assessed using a digital hand-held algometer. Pressure was progressively applied to eight craniofacial sites, and participants indicated the point at which the pressure sensation first became painful. Measurements were expressed in kilopascals (kPa). The eight-site assessment was used to characterize cephalic pressure pain sensitivity across multiple craniofacial regions rather than relying on a single measurement site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Two separate assessor-blinded randomized crossover experiments, one in participants with migraine and one in participants without migraine. Within each cohort, participants received both experimental conditions in a randomized order.
| Arm | Type | Receives |
|---|---|---|
| Migraine: Prayer First | Experimental | Behavioral: Prayer Condition, Behavioral: Reading ConditionParticipants with migraine randomized to the prayer-first sequence received the prayer condition at the first study visit and the non-spiritual reading condition at the second study visit. |
| Migraine: Reading First | Experimental | Behavioral: Prayer Condition, Behavioral: Reading ConditionParticipants with migraine randomized to the reading-first sequence received the non-spiritual reading condition at the first study visit and the prayer condition at the second study visit. |
| Non-Migraine: Prayer First | Experimental | Behavioral: Prayer Condition, Behavioral: Reading ConditionParticipants without migraine randomized to the prayer-first sequence received the prayer condition at the first study visit and the non-spiritual reading condition at the second study visit. |
| Non-Migraine: Reading First | Experimental | Behavioral: Prayer Condition, Behavioral: Reading ConditionParticipants without migraine randomized to the reading-first sequence received the non-spiritual reading condition at the first study visit and the prayer condition at the second study visit. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of chronic or episodic migraine.
- Feeling comfortable performing a known prayer.
Key exclusion criteria (3 listed)
- Severe acute circulatory disorders
- Decompensated diabetes mellitus
- Cognitive weaknesses that prevent the patient from understanding and carrying out the study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prayer ConditionParticipants performed a 10-minute session of silent personal prayer using a prayer they were already familiar with and commonly practiced. Participants were instructed to pray in their usual way without vocalization, focusing on the content/meaning of the prayer. If distracted, they were asked to gently refocus on prayer. | Behavioural | Migraine: Prayer First, Migraine: Reading First, Non-Migraine: Prayer First, Non-Migraine: Reading First |
| Reading ConditionIn the reading condition, participants read a non-spiritual text with no spiritual or religious content for 10 minutes. If distracted, they were instructed to refocus on the text. | Behavioural | Migraine: Prayer First, Migraine: Reading First, Non-Migraine: Prayer First, Non-Migraine: Reading First |
Primary outcome
Total Cephalic Pressure Pain Threshold (PPT)
Time frame: Immediately before and immediately after each experimental condition
Cephalic pressure pain threshold (PPT) was assessed using a digital algometer at eight craniofacial sites. The primary outcome was the total cephalic PPT, calculated as the sum of the eight site-specific PPT measurements and expressed in kilopascals (kPa). Higher values indicate a higher pressure pain threshold.
4 secondary outcomes
Spirituality scores using the Functional Assessment of Chronic Illness Therapy - Spiritual Well-being (FACIT-Sp) scale
Time frame: Baseline, before the experimental conditions
Level of religiosity using the Duke Religious Index (DUREL)
Time frame: Baseline, before the experimental conditions
Anxiety Variables using Generalized Anxiety Disorder Screener (GAD-7 Scale)
Time frame: Baseline, before the experimental conditions
Depression Variables - Patient Health Questionnaire (PHQ-9 Scale)
Time frame: Baseline, before the experimental conditions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prayer Condition and Reading Condition in people with Migraine, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Cephalic Pressure Pain Threshold (PPT) (time frame: Immediately before and immediately after each experimental condition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.