Brief Video-Based Mindful Movement Intervention Prior to Pelvic Exams

Study Overview
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Brief Summary
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This study endeavors to implement a brief video-based mindfulness intervention within a clinic setting for women undergoing pelvic examinations, in hopes of reducing state anxiety and pain intensity during pelvic exams and improving overall exam satisfaction and likelihood to return for follow-up exams. This will be a pilot study will take place the University of Texas Southwestern (UTSW) Lowe Foundation Center for Women's Preventative Health Care. There will be a treatment and a control arm, estimated 50 women per group.

Detailed Description
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Participants will be randomly assigned to either a treatment group or a control group. Treatment group will receive a 5-minute mindful movement video-based intervention before their previously scheduled pelvic exam. Control group will not receive the mindful movement video-based intervention and will instead be given a handout about the benefits of mindfulness to read prior to the pelvic exam. Control group will be given access to the mindfulness intervention via an online link upon completion of participation in the study to ensure they are provided the opportunity to benefit from mindfulness practice. Participants will be recruited from a group of female patients at the Lowe Foundation Center who have already been scheduled for an upcoming pelvic exam. Therefore the pelvic exam procedure itself is standard of care, the experimental piece is the mindfulness intervention before the pelvic exam - either the video, or the written educational materials depending on whether participants are randomly assigned to the treatment or control group.

Official Title
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Brief Video-Based Mindful Movement Intervention Prior to Pelvic Exams

Conditions
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Anxiety State, Pain, Depression

Intervention / Treatment
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* Behavioral: 5-Minute Mindful Movement Video
* Behavioral: Written Educative Materials


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Age of 18+ years Scheduled physical evaluation including pelvic exam at UT Southwestern's Lowe Foundation Center for Women's Preventative Health Care. Exclusion Criteria: Participants who are unable to read, speak, write or understand verbally spoken English Participants who are blind or otherwise visually impaired will be excluded due to nature of video intervention. Participants who are pregnant will be excluded from the study. Individuals presenting to the clinic for an acute pain reason will be excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5-Minute Mindful Movement Video<br>5 minute mindful movement video watched in the exam room on an iPad | Behavioral: 5-Minute Mindful Movement Video<br>* 5 minute video includes a brief verbal introduction to mindfulness and then guides participants through a mindful movement exercise to facilitate grounding in the present moment and activation of the parasympathetic nervous system.<br>|
| Placebo Comparator: Written Educative Materials<br>1 page printed written educative material about mindfulness benefits read for 5 minutes in the exam room | Behavioral: Written Educative Materials<br>* 1 page written educative material about the benefits of mindfulness to serve as a control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale - Anxiety 1 (Change in Anxiety) | Using an iPad, participant slides a bar on a scale to the right or left to indicate level of anxiety. All the way to the right indicates highest anxiety (100) all the way to the left indicates no anxiety (0). Higher number indicates worse outcome/more anxiety. | baseline, pre-intervention/procedure | 
| Visual Analogue Scale - Anxiety 2 (Change in Anxiety) | Using an iPad, participant slides a bar on a scale to the right or left to indicate level of anxiety. All the way to the right indicates highest anxiety (100) all the way to the left indicates no anxiety (0). Higher number indicates worse outcome/more anxiety. | immediately after the intervention | 
| Visual Analogue Scale - Anxiety 3 (Change in Anxiety) | Using an iPad, participant slides a bar on a scale to the right or left to indicate level of anxiety. All the way to the right indicates highest anxiety (100) all the way to the left indicates no anxiety (0). Higher number indicates worse outcome/more anxiety. | immediately after the procedure | 
| Visual Analogue Scale - Pain 1 | Using an iPad, participant slides a bar on a scale to the right or left to indicate level of pain. All the way to the right indicates highest pain (100) all the way to the left indicates no pain (0). Higher number indicates worse outcome/more pain. | baseline, pre-intervention | 
| Visual Analogue Scale - Pain 2 | Using an iPad, participant slides a bar on a scale to the right or left to indicate level of pain. All the way to the right indicates highest pain (100) all the way to the left indicates no pain (0). Higher number indicates worse outcome/more pain. | immediately after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire (PHQ-9) | Depression symptom severity scale; 9 items with a total score ranging from 0-27, higher score means a greater number of depressive symptoms endorsed. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. | baseline, pre-intervention/procedure | 
| Exam Satisfaction Survey | Assess overall patient satisfaction with exam, and likelihood to attend future appointments | immediately after the procedure | 
| Mindfulness Perceptions Survey | Treatment group completes a survey regarding perceptions of mindfulness video | immediately after the procedure | 
| Physician Experience Survey | Physician who completes the pelvic exam will rate their experience completing the pelvic exam | immediately after the procedure |