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Brief Video-Based Mindful Movement Intervention Prior to Pelvic Exams

Primary Purpose

Anxiety State, Pain, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
5-Minute Mindful Movement Video
Written Educative Materials
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anxiety State

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Female
  2. Age of 18+ years
  3. Scheduled physical evaluation including pelvic exam at UT Southwestern's Lowe Foundation Center for Women's Preventative Health Care.

Exclusion Criteria:

  1. Participants who are unable to read, speak, write or understand verbally spoken English
  2. Participants who are blind or otherwise visually impaired will be excluded due to nature of video intervention.
  3. Participants who are pregnant will be excluded from the study.
  4. Individuals presenting to the clinic for an acute pain reason will be excluded from the study.

Sites / Locations

  • UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

5-Minute Mindful Movement Video

Written Educative Materials

Arm Description

5 minute mindful movement video watched in the exam room on an iPad

1 page printed written educative material about mindfulness benefits read for 5 minutes in the exam room

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
Exam Satisfaction Survey
Assess overall patient satisfaction with exam, and likelihood to attend future appointments
Mindfulness Perceptions Survey
Treatment group completes a survey regarding perceptions of mindfulness video
Physician Experience Survey
Physician who completes the pelvic exam will rate their experience completing the pelvic exam

Full Information

First Posted
January 11, 2021
Last Updated
April 23, 2021
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04728503
Brief Title
Brief Video-Based Mindful Movement Intervention Prior to Pelvic Exams
Official Title
Brief Video-Based Mindful Movement Intervention Prior to Pelvic Exams
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 8, 2020 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety State, Pain, Depression

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5-Minute Mindful Movement Video
Arm Type
Experimental
Arm Description
5 minute mindful movement video watched in the exam room on an iPad
Arm Title
Written Educative Materials
Arm Type
Placebo Comparator
Arm Description
1 page printed written educative material about mindfulness benefits read for 5 minutes in the exam room
Intervention Type
Behavioral
Intervention Name(s)
5-Minute Mindful Movement Video
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Written Educative Materials
Intervention Description
1 page written educative material about the benefits of mindfulness to serve as a control.
Primary Outcome Measure Information:
Title
Visual Analogue Scale - Anxiety 1 (Change in Anxiety)
Description
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.
Time Frame
baseline, pre-intervention/procedure
Title
Visual Analogue Scale - Anxiety 2 (Change in Anxiety)
Description
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.
Time Frame
immediately after the intervention
Title
Visual Analogue Scale - Anxiety 3 (Change in Anxiety)
Description
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.
Time Frame
immediately after the procedure
Title
Visual Analogue Scale - Pain 1
Description
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.
Time Frame
baseline, pre-intervention
Title
Visual Analogue Scale - Pain 2
Description
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.
Time Frame
immediately after the procedure
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9)
Description
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.
Time Frame
baseline, pre-intervention/procedure
Title
Exam Satisfaction Survey
Description
Assess overall patient satisfaction with exam, and likelihood to attend future appointments
Time Frame
immediately after the procedure
Title
Mindfulness Perceptions Survey
Description
Treatment group completes a survey regarding perceptions of mindfulness video
Time Frame
immediately after the procedure
Title
Physician Experience Survey
Description
Physician who completes the pelvic exam will rate their experience completing the pelvic exam
Time Frame
immediately after the procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracy Greer, PhD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not have a formal data sharing plan; however, if investigators are interested in using these data, they may contact us to determine if that may be possible.

Learn more about this trial

Brief Video-Based Mindful Movement Intervention Prior to Pelvic Exams

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