Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586086
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
The Effect of Anxiety on Pain-pressure Threshold in a Healthy Population
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Anxiety on Pain-pressure Threshold in a Healthy Population
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study recruit individuals who are 18 years of age AND Do NOT have a history of diagnosed anxiety disorders AND Do NOT currently have any area of pain lasting 3 months or longer
The study will measure discomfort with a controlled application of pressure to different muscles and compare these measures with the individuals score on a standardized assessment of anxiety
The study will measure discomfort with a controlled application of pressure to different muscles and compare these measures with the individuals score on a standardized assessment of anxiety
Detailed Description:
Purpose Anxiety in general has been associated with lower more sensitive pain-pressure thresholds however to the best of the investigators knowledge no research has attempted to differentiate state versus trait anxiety and their respective impacts on pressure sensitivity
Trait anxiety is an individuals tendency to appraise situations as threatening avoid anxiety provoking situations and demonstrate high baseline physiological arousal State anxiety is defined as transient state of arousal subjectively experienced as anxiety This studys objective is to differentiate the role of each anxiety subscale in systemic sensory perception changes This data may better allow clinicians to glean accurate data about an individuals baseline symptoms as well as potentially shedding light on state-related changes in pain thresholds
Objectives The primary objective of this study will be to elucidate the differing relationships of trait anxiety and state anxiety on pain-pressure threshold PPT While other measures exist to gauge potential sensitization to sensory stimuli PPT is often chosen for research due to the ease of administration and its ability to translate data into practice
Study Population Target population will be healthy adults age 18 As will be delineated further in this document this study will recruit healthy adults such as to minimize potential modifications in sensory perception due to comorbidities medication etc
Number of Participants The study will enroll 60 participants to provide more robust statistical power
Study Design The study will be a descriptive cross-sectional design The study will seek to draw associations between the different anxiety subscales and the subjects pain-pressure threshold No variables will be manipulated
Study Duration The study participants will complete the STAI-5 a validated short version of the State-Trait Anxiety Inventory Immediately after questionnaire administration participants will be tested for pain-pressure thresholds Each participant session will last approximately 30 minutes The entire study duration will be 20 weeks to allow for test administration for all participants
Outcome Variables The outcome variable in question is pain-pressure threshold for the bilateral upper trapezius extensor carpi radialis Tibialis anterior and lumbar paraspinal L3 segment level muscles Each site will be tested three times and the results will be averaged The mean score from both sides will also subsequently be averaged to provide a single numerical outcome for each participant PPT data for each participant will be compared with both Trait and State anxiety scores from the STAI-5 tool
LocationsFacilities The research will be conducted entirely within the research suite in the Physical Therapy Department of the Philadelphia College of Osteopathic Medicine-Georgia Campus Suwanee GA
Trait anxiety is an individuals tendency to appraise situations as threatening avoid anxiety provoking situations and demonstrate high baseline physiological arousal State anxiety is defined as transient state of arousal subjectively experienced as anxiety This studys objective is to differentiate the role of each anxiety subscale in systemic sensory perception changes This data may better allow clinicians to glean accurate data about an individuals baseline symptoms as well as potentially shedding light on state-related changes in pain thresholds
Objectives The primary objective of this study will be to elucidate the differing relationships of trait anxiety and state anxiety on pain-pressure threshold PPT While other measures exist to gauge potential sensitization to sensory stimuli PPT is often chosen for research due to the ease of administration and its ability to translate data into practice
Study Population Target population will be healthy adults age 18 As will be delineated further in this document this study will recruit healthy adults such as to minimize potential modifications in sensory perception due to comorbidities medication etc
Number of Participants The study will enroll 60 participants to provide more robust statistical power
Study Design The study will be a descriptive cross-sectional design The study will seek to draw associations between the different anxiety subscales and the subjects pain-pressure threshold No variables will be manipulated
Study Duration The study participants will complete the STAI-5 a validated short version of the State-Trait Anxiety Inventory Immediately after questionnaire administration participants will be tested for pain-pressure thresholds Each participant session will last approximately 30 minutes The entire study duration will be 20 weeks to allow for test administration for all participants
Outcome Variables The outcome variable in question is pain-pressure threshold for the bilateral upper trapezius extensor carpi radialis Tibialis anterior and lumbar paraspinal L3 segment level muscles Each site will be tested three times and the results will be averaged The mean score from both sides will also subsequently be averaged to provide a single numerical outcome for each participant PPT data for each participant will be compared with both Trait and State anxiety scores from the STAI-5 tool
LocationsFacilities The research will be conducted entirely within the research suite in the Physical Therapy Department of the Philadelphia College of Osteopathic Medicine-Georgia Campus Suwanee GA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None