Ignite Creation Date:
2024-05-06 @ 1:07 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03939949
Status:
UNKNOWN
Last Update Posted:
2021-10-26
First Post:
2019-02-09
Brief Title:
Mindfully Attending to Pain Sensations
Sponsor:
Harvard University
Organization:
Harvard University
Study Overview
Official Title:
Mindfully Attending to Pain Sensations
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
ACTIVE_NOT_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:
None
Brief Summary:
Substantial evidence suggests that psychosocial factors play a key role in explaining the risk for development of chronic pain as well as for coping with it Such factors include psychological perceptions or orientation towards pain mainly referring to fear of pain and pain catastrophizing Nonetheless although this link is well documented the underlying mechanisms of these processes have yet to be established The Attention to Variability paradigm presents an explanatory mechanism according to which the ability to mindfully attend to chronic symptoms enables and promotes increased control over the etiology and the expression of chronic symptoms In support of the ATV paradigm empirical findings demonstrate that ATV improved pregnancy outcomes and allowed people to gain control over fluctuations in their heart rates
The goal of the present study is to examine whether mindfully attending to pain sensations will decrease the intensity and frequency of chronic pain increase perceived control of pain and improve well-being and health-related quality of life
The goal of the present study is to examine whether mindfully attending to pain sensations will decrease the intensity and frequency of chronic pain increase perceived control of pain and improve well-being and health-related quality of life
Detailed Description:
Participants who experience chronic pain will be randomly assigned to one of three experimental groups which differ in the content and scheduling of text messages delivered over a period of six days One third of participants will be assigned to the active control group These participants will receive 2 text messages per day for six days one at 9am and one at 9pm asking them to report on the activity they are currently engaged in One third of participants will be assigned to the low mindfulness group These participants will receive the same text messages as the participants in the active control group but will also be prompted with the 9pm text to report on pain intensity and unpleasantness at that time One third of participants will be assigned to the high mindfulness group These participants will also receive two text message prompts about their current activity Participants in the high mindfulness group will also receive questions about current pain intensity and unpleasantness in both the morning and evening In order to emphasize the variability in pain participants will receive these text messages on a variable schedule In addition they will sent instructions every morning to pay attention to variability in their pain throughout the day and asked to report on how their pain is changing over time as a part of each text message prompt
The researchers will take measurements of pain interference perceptions of control and pain experience at three time points T0baseline T1 immediately after the 6 days of text messages T2 1 month after T1 and T3 3 months after T1 All surveys will be collected online via the Qualtricscom platform
The researchers will take measurements of pain interference perceptions of control and pain experience at three time points T0baseline T1 immediately after the 6 days of text messages T2 1 month after T1 and T3 3 months after T1 All surveys will be collected online via the Qualtricscom platform
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