NCT04614272

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

October 20, 2020

Last Update Submit

August 31, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • The Duke University Religion Index

    religiosity is assessed at baseline

  • Prayer function scale

    the prayer function scale is assessed at baseline

Study Arms (3)

active prayer group

EXPERIMENTAL

the active prayer group will mediate over an active type of prayer

Behavioral: Prayer

passive prayer group

EXPERIMENTAL

the passive prayer group will mediate over a passive type of prayer

Behavioral: Prayer

control group

SHAM COMPARATOR

the control group will read a poem

Behavioral: Reading a poem

Interventions

PrayerBEHAVIORAL

Prayer is a non-pharmaceutical method of pain management and a form of alternative medicine.

active prayer grouppassive prayer group
Reading a poemBEHAVIORAL

Reading is a distraction tool for pain management

control group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antonine University

Beirut, Lebanon

Location

MeSH Terms

Interventions

Faith Healing

Intervention Hierarchy (Ancestors)

Spiritual TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Mira Meeus, Phd

    University Ghent

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant professor

Study Record Dates

First Submitted

October 20, 2020

First Posted

November 3, 2020

Study Start

November 1, 2020

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

September 5, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

the data will only be used for this study

Locations