Clinical trial NCT04614272: Effect of Prayer on Conditioned Pain Modulation and on Pain Intensity in Healthy Religious University Students
Official title: The Effect of Praying on Endogenous Pain Modulation and Pain Intensity in Healthy Religious Individuals: A Randomized Controlled Experiment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: Antonine University
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2020-11-03
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: change in conditioned pain modulation (CPM)
timeFrame: Measured prior to intervention (baseline=day 1) and immediate following the intervention (=day 1)
measure: change in pain intensity
timeFrame: Measured prior to intervention (baseline=day 1) and immediate following the intervention (=day 1)
Secondary outcomes:
measure: The Duke University Religion Index
timeFrame: religiosity is assessed at baseline
measure: Prayer function scale
timeFrame: the prayer function scale is assessed at baseline
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Antonine University
Study officials:
affiliation: University Ghent
name: Mira Meeus, Phd
role: STUDY_DIRECTOR
References: