Ignite Creation Date:
2024-05-06 @ 3:00 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04491630
Status:
UNKNOWN
Last Update Posted:
2020-07-29
First Post:
2020-07-23
Brief Title:
COping With PAin Through Hypnosis Mindfulness and Spirituality
Sponsor:
ISPA - Instituto Universitario de Ciencias Psicologicas Sociais e da Vida
Organization:
ISPA - Instituto Universitario de Ciencias Psicologicas Sociais e da Vida
Study Overview
Official Title:
COping With PAin Through Hypnosis Mindfulness and Spirituality
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPAHS
Brief Summary:
The purpose of this study is to evaluate and compare the immediate effects of self-hypnosis mindfulness meditation and a spiritual intervention relative to a control condition for increasing pain tolerance and reducing pain intensity and pain-related stress in response to experimental painful stimulation
Detailed Description:
The primary aim of this study Aim 1 is to compare the immediate effects of self-hypnosis SH mindfulness meditation MM and Christian meditation CM relative to a control group CN for increasing pain tolerance and reducing pain intensity and pain-related stress in response to experimental painful stimulation in a sample of healthy volunteers
An exploratory aim of this study Aim 2 is to identify possible shared and unique predictors of response to the three treatment conditions The possible predictors we plan to test include sex age religious affiliation hypnotic suggestibility baseline mindfulness acceptance pain-related beliefs religiosity trait spirituality previous experience with SH MM and CP outcome expectancies and trait absorption
This is a randomized quantitative experimental mixed-model repeated-measures study with three assessment points baseline T0 pre-test T1 and post-test T2 Eligible healthy adults will be randomized to one of the four study conditions Interventions will be a 20-minutes audio-guided practice of either self-hypnosis mindfulness meditation or Christian prayer Participants in the control group will not be instructed to use any specific strategy during the painful stimulation Participants will be submitted to a first cycle of Cold Pressor Arm Wrap They will then listen to a 20-minutes audio recording inducing one of the three interventions or in the case of the control group to a 20-minutes recording of a natural history textbook Primary outcomes are pain intensity pain tolerance and pain-related stress as measured by salivary cortisol level and heart rate variability
An exploratory aim of this study Aim 2 is to identify possible shared and unique predictors of response to the three treatment conditions The possible predictors we plan to test include sex age religious affiliation hypnotic suggestibility baseline mindfulness acceptance pain-related beliefs religiosity trait spirituality previous experience with SH MM and CP outcome expectancies and trait absorption
This is a randomized quantitative experimental mixed-model repeated-measures study with three assessment points baseline T0 pre-test T1 and post-test T2 Eligible healthy adults will be randomized to one of the four study conditions Interventions will be a 20-minutes audio-guided practice of either self-hypnosis mindfulness meditation or Christian prayer Participants in the control group will not be instructed to use any specific strategy during the painful stimulation Participants will be submitted to a first cycle of Cold Pressor Arm Wrap They will then listen to a 20-minutes audio recording inducing one of the three interventions or in the case of the control group to a 20-minutes recording of a natural history textbook Primary outcomes are pain intensity pain tolerance and pain-related stress as measured by salivary cortisol level and heart rate variability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None