Effect of Prayer on Conditioned Pain Modulation and on Pain Intensity in Healthy Religious University Students
Primary Purpose
Healthy Subjects
Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Prayer
Reading a poem
Sponsored by
About this trial
This is an interventional screening trial for Healthy Subjects
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.
Sites / Locations
- Antonine University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
active prayer group
passive prayer group
control group
Arm Description
the active prayer group will mediate over an active type of prayer
the passive prayer group will mediate over a passive type of prayer
the control group will read a poem
Outcomes
Primary Outcome Measures
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
change in pain intensity
numeric rating scale from 0 to 100 where 0 is no pain and 100 is the worst pain imaginable
Secondary Outcome Measures
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 .
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.
Full Information
NCT ID
NCT04614272
First Posted
October 20, 2020
Last Updated
August 31, 2021
Sponsor
Antonine University
Collaborators
University Ghent
1. Study Identification
Unique Protocol Identification Number
NCT04614272
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
February 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Antonine University
Collaborators
University Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
while assessing for endogenous pain inhibition and pain intensity the assessor will be blind and will not know to which group the participant belong. Participants will be blinded by being blind to the study hypothesis.
Allocation
Randomized
Enrollment
208 (Actual)
8. Arms, Groups, and Interventions
Arm Title
active prayer group
Arm Type
Experimental
Arm Description
the active prayer group will mediate over an active type of prayer
Arm Title
passive prayer group
Arm Type
Experimental
Arm Description
the passive prayer group will mediate over a passive type of prayer
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
the control group will read a poem
Intervention Type
Behavioral
Intervention Name(s)
Prayer
Intervention Description
Prayer is a non-pharmaceutical method of pain management and a form of alternative medicine.
Intervention Type
Behavioral
Intervention Name(s)
Reading a poem
Intervention Description
Reading is a distraction tool for pain management
Primary Outcome Measure Information:
Title
change in conditioned pain modulation (CPM)
Description
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
Time Frame
Measured prior to intervention (baseline=day 1) and immediate following the intervention (=day 1)
Title
change in pain intensity
Description
numeric rating scale from 0 to 100 where 0 is no pain and 100 is the worst pain imaginable
Time Frame
Measured prior to intervention (baseline=day 1) and immediate following the intervention (=day 1)
Secondary Outcome Measure Information:
Title
The Duke University Religion Index
Description
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 .
Time Frame
religiosity is assessed at baseline
Title
Prayer function scale
Description
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.
Time Frame
the prayer function scale is assessed at baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mira Meeus, Phd
Organizational Affiliation
University Ghent
Official's Role
Study Director
Facility Information:
Facility Name
Antonine University
City
Beirut
Country
Lebanon
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
the data will only be used for this study
Learn more about this trial
Effect of Prayer on Conditioned Pain Modulation and on Pain Intensity in Healthy Religious University Students
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