To refine and evaluate the feasibility of procedures for a future full-scale efficacy trial of a group-based therapeutic yoga intervention versus physical conditioning (stretching and strengthening) intervention for women with chronic pelvic pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
The yoga program is designed to maximize women's awareness of and control over the pelvic floor, promote relaxation, and improve physical function.
The physical conditioning program will focus on a core set of exercises designed to improve physical function and emotional well-being in order to improve management of chronic pain.
University of California, San Francisco
Oakland, California, United States
Stanford University
Palo Alto, California, United States
University of California, San Francisco
San Francisco, California, United States
Number of Randomized Participants Who: a) Are Retained at 8 Weeks, b) Attend at Least 75% of Intervention Classes, c) Demonstrate at Least Moderate Intervention Self-efficacy, and d) Provide Pain Outcomes Data at 8 Weeks.
Number of randomized participants who: a) are retained at 8 weeks, b) attend at least 75% of intervention classes, c) demonstrate at least moderate intervention self-efficacy, and d) provide pain outcomes data at 8 weeks.
Time frame: 8 weeks
Percentage of Screenees Who Are Eventually Randomized
Percentage of screenees who are eventually randomized
Time frame: Randomization
Percentage of Randomized Participants Who Drop Out by 8 Weeks
Percentage of randomized participants who drop out by 8 weeks
Time frame: 8 weeks
Percentage of Non-drop-outs Completing at Least 75% of Intervention Classes Over 8 Weeks
Percentage of non-drop-outs completing at least 75% of intervention classes over 8 weeks
Time frame: 8 weeks
Percentage of Non-drop-outs Completing at Least 75% of Home Intervention Practice Over 8 Weeks
Percentage of non-drop-outs completing at least 75% of home intervention practice over 8 weeks
Time frame: 8 weeks
Percentage of Participants With at Least Moderate Self-efficacy in Performing Postures/Exercises at 8 Weeks
Participants will rate their self-confidence in performing each posture/exercise on a 5-point Likert scale (5-extremely, 4-very, 3-moderately, 2-somewhat, and 1-not at all confident. The percentage of participants with an average self-confidence score of 3 or higher across postures/exercises at 8 weeks will be calculated.
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Time frame: 8 weeks
Percentage of Participants Rated by a Consultant as Being at Least Moderately Competent in Performing Postures/Exercises at 8 Weeks
Expert consultants will observe and rate participants' success in performing each posture/exercise on a 5-point Likert scale (5-extremely, 4-very, 3-moderately, 2-somewhat, and 1-not at all confident. The percentage of participants with an average competence rating of 3 or higher across postures/exercises at 8 weeks will be calculated.
Time frame: 8 weeks
Percentage of Participants With Expected Pain Logs Returned at 8 Weeks
Percentage of participants with expected pain logs returned at 8 weeks
Time frame: 8 weeks
Percentage of Participants With Expected Pain Interference Questionnaires Returned at 8 Weeks
Percentage of participants with expected pain interference questionnaires returned at 8 weeks
Time frame: 8 weeks
Percentage of Participants With Expected Pelvic Pain Impact Measures Returned at 8 Weeks
Percentage of participants with expected pelvic pain impact measures returned at 8 weeks
Time frame: 8 weeks