Healthy SubjectsNCT04614272
Effect of Prayer on Conditioned Pain Modulation and on Pain Intensity in Healthy Religious University Students
A study testing Prayer and Reading a poem in people with Healthy Subjects, run by Antonine University at 1 site in Lebanon.
Trial summary
With this study the investigators wish to examine the effect of prayer on pain intensity and on the conditioned pain modulation in healthy religious university students. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Prayer and Reading a poem
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Nov 2020to 1 Feb 2021
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female.
- Healthy male.
- University students
- Religious participants who would score at least two over six on the Non Organizational Religious Activities subscale of the Duke University Religious Index.
Who cannot join
- Pregnant women.
- Individuals with chronic pain.
- Individuals with psychiatric disease.
- Individuals suffering from headache for more than 2 days a month.
- Individuals with high blood pressure.
- Individuals under regular use of medication.
- Individuals who would score 1 or 0 on the on the Non Organizational Religious Activities subscale of the Duke University Religious Index.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Praying on Endogenous Pain Modulation and Pain Intensity in Healthy Religious Individuals: A Randomized Controlled Experiment
With this study the investigators wish to examine the effect of prayer on pain intensity and on the conditioned pain modulation in healthy religious university students.
Read the detailed description
There has been a call for a model that incorporate spirituality in the biopsychosocial framework .The biopsychosocial- spiritual model recognizes the impact of the religious factors in modulating the biology of pain.
The aim of this study is to measure the effect of praying as an intervention on conditioned pain modulation and on pain intensity.
The investigators hypothesize that prayer would increase conditioned pain modulation compared to a no prayer control group in a healthy religious population.
The investigators hypothesize that participants engaging in active prayer will show a higher increase in conditioned pain modulation compared to those engaging in passive prayer or no prayer.
The present study is a randomized controlled trial comparing the effect of two types of prayer, the passive and the active prayer and no prayer, on conditioned pain modulation using the heat protocol and on pain intensity. Participants are to be randomly assigned to 2 groups: the prayer group and the control group.
The control group is of (n=50) participants and the prayer group is (n=150) participants to be divided according to the style of praying identified by the prayer function scale into active and passive prayer group.
Appropriate statistical analyses will be performed to evaluate and compare treatment effects.
- Conditions
- Healthy Subjects
- Being tested
- Prayer, Reading a poem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrayerBehavioural
Prayer is a non-pharmaceutical method of pain management and a form of alternative medicine.
Reading a poemBehavioural
Reading is a distraction tool for pain management
| Study group | Role | What they receive |
|---|---|---|
| active prayer group | Experimental | the active prayer group will mediate over an active type of prayer Receives: Behavioral: Prayer |
| passive prayer group | Experimental | the passive prayer group will mediate over a passive type of prayer Receives: Behavioral: Prayer |
| control group | Sham comparator | the control group will read a poem Receives: Behavioral: Reading a poem |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in conditioned pain modulation (CPM)
the conditioned pain modulation paradigm (pressure pain threshold using a digital algometer as test stimulus and the heat pressor test (immersion of one hand in hot water of 45.5°C) as conditioning stimulus
Measured: Measured prior to intervention (baseline=day 1) and immediate following the intervention (=day 1)
change in pain intensity
numeric rating scale from 0 to 100 where 0 is no pain and 100 is the worst pain imaginable
Measured: Measured prior to intervention (baseline=day 1) and immediate following the intervention (=day 1)
Secondary outcomes (2)
The Duke University Religion Index
1.The religiosity level will be measured using the Duke University Religiosity scale, it is a 5-item self-report measure of religious involvement scored on a 5-point Likert-type scale ranging from 1 (almost never) to 5 (a great deal). It assesses the three major dimensions of religiosity, organizational religious activity, non-organizational religious activity, and intrinsic religiosity .
Measured: religiosity is assessed at baseline
Prayer function scale
is a self-report instrument that assesses the motivation or purpose behind an individual's prayer while she or he is coping with difficult circumstances.
The scale consists of 58 items that are scored on a 5-point Likert-type scale ranging from 1 (almost never) to 5 (a great deal).
The measure contains four scales: Provides Acceptance (17 items), Provides Calm and Focus (11 items), Deferring/Avoiding , and Provides Assistance (14 items).
The deferring/avoiding scale represent a passive type of prayer The assistance scale represent an active type of prayer.
Measured: the prayer function scale is assessed at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start1 Nov 2020
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antonine University
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Principal investigator, charbel najem, Antonine University
- Investigators
- Mira Meeus, Phd, Study director, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614272
- Sponsor's protocol ID
- charbel najem
- Status last verified
- Aug 2021
- First submitted
- 20 Oct 2020
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the data will only be used for this study
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Praying on Endogenous Pain Modulation and Pain Intensity in Healthy Religious Individuals: A Randomized Controlled Experiment
- ClinicalTrials.gov ID
- NCT04614272
- Acronym / sponsor ID
- charbel najem
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Antonine UniversityUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 3 Nov 2020 (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.
With this study the investigators wish to examine the effect of prayer on pain intensity and on the conditioned pain modulation in healthy religious university students.
Detailed description
There has been a call for a model that incorporate spirituality in the biopsychosocial framework .The biopsychosocial- spiritual model recognizes the impact of the religious factors in modulating the biology of pain.
The aim of this study is to measure the effect of praying as an intervention on conditioned pain modulation and on pain intensity.
The investigators hypothesize that prayer would increase conditioned pain modulation compared to a no prayer control group in a healthy religious population.
The investigators hypothesize that participants engaging in active prayer will show a higher increase in conditioned pain modulation compared to those engaging in passive prayer or no prayer.
The present study is a randomized controlled trial comparing the effect of two types of prayer, the passive and the active prayer and no prayer, on conditioned pain modulation using the heat protocol and on pain intensity. Participants are to be randomly assigned to 2 groups: the prayer group and the control group.
The control group is of (n=50) participants and the prayer group is (n=150) participants to be divided according to the style of praying identified by the prayer function scale into active and passive prayer group.
Appropriate statistical analyses will be performed to evaluate and compare treatment effects.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| active prayer group | Experimental | Behavioral: Prayerthe active prayer group will mediate over an active type of prayer |
| passive prayer group | Experimental | Behavioral: Prayerthe passive prayer group will mediate over a passive type of prayer |
| control group | Sham comparator | Behavioral: Reading a poemthe control group will read a poem |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy female.
- Healthy male.
- University students
- Religious participants who would score at least two over six on the Non Organizational Religious Activities subscale of the Duke University Religious Index.
Key exclusion criteria (7 listed)
- Pregnant women.
- Individuals with chronic pain.
- Individuals with psychiatric disease.
- Individuals suffering from headache for more than 2 days a month.
- Individuals with high blood pressure.
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 |
|---|---|---|
| PrayerPrayer is a non-pharmaceutical method of pain management and a form of alternative medicine. | Behavioural | active prayer group, passive prayer group |
| Reading a poemReading is a distraction tool for pain management | Behavioural | control group |
Primary outcome
change in conditioned pain modulation (CPM)
Time frame: Measured prior to intervention (baseline=day 1) and immediate following the intervention (=day 1)
the conditioned pain modulation paradigm (pressure pain threshold using a digital algometer as test stimulus and the heat pressor test (immersion of one hand in hot water of 45.5°C) as conditioning stimulus
change in pain intensity
Time frame: Measured prior to intervention (baseline=day 1) and immediate following the intervention (=day 1)
numeric rating scale from 0 to 100 where 0 is no pain and 100 is the worst pain imaginable
2 secondary outcomes
The Duke University Religion Index
Time frame: religiosity is assessed at baseline
Prayer function scale
Time frame: the prayer function scale is assessed at baseline
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 5 Sep 2021.
- Individual participant dataSharing planned: No. the data will only be used for this study
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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.
Mira Meeus, Phd study director
University Ghent
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 and Reading a poem in people with Healthy Subjects, run by Antonine University at 1 site in Lebanon.
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 4 inclusion and 7 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 5 Sep 2021. 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 Lebanon. 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. Some participants in this study may receive a placebo. 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?
change in conditioned pain modulation (CPM) (time frame: Measured prior to intervention (baseline=day 1) and immediate following the intervention (=day 1)). The study lists 2 primary outcomes in all. 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 5 Sep 2021.