Effect of Prayer on Conditioned Pain Modulation and on Pain Intensity in Healthy Religious University Students

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Behavioral: Prayer; Behavioral: Reading a poem

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 Type: Interventional
• Enrollment (Actual): 208
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Antonine University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 21 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active prayer group; the active prayer group will mediate over an active type of prayer	Behavioral: Prayer; Prayer is a non-pharmaceutical method of pain management and a form of alternative medicine.
Experimental: passive prayer group; the passive prayer group will mediate over a passive type of prayer	Behavioral: Prayer; Prayer is a non-pharmaceutical method of pain management and a form of alternative medicine.
Sham Comparator: control group; the control group will read a poem	Behavioral: Reading a poem; Reading is a distraction tool for pain management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 prior to intervention (baseline=day 1) and immediate following the intervention (=day 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 .	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.	the prayer function scale is assessed at baseline

Collaborators and Investigators

• Sponsor: Antonine University
• Collaborators: University Ghent
• Investigators: Study Director: Mira Meeus, Phd, University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: November 1, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Pain
• Other Study ID Numbers: charbel najem

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: the data will only be used for this study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No