Brief Video-Based Mindful Movement Intervention Prior to Pelvic Exams

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.

Study Overview

• Status: Completed
• Conditions: Depression; Pain; Anxiety State
• Intervention / Treatment: Behavioral: 5-Minute Mindful Movement Video; Behavioral: Written Educative Materials

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 5-Minute Mindful Movement Video; 5 minute mindful movement video watched in the exam room on an iPad	Behavioral: 5-Minute Mindful Movement Video; 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.
PLACEBO_COMPARATOR: Written Educative Materials; 1 page printed written educative material about mindfulness benefits read for 5 minutes in the exam room	Behavioral: Written Educative Materials; 1 page written educative material about the benefits of mindfulness to serve as a control.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Tracy Greer, PhD, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 8, 2020
• Primary Completion (ACTUAL): April 1, 2021
• Study Completion (ACTUAL): April 1, 2021

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: January 24, 2021
• First Posted (ACTUAL): January 28, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 26, 2021
• Last Update Submitted That Met QC Criteria: April 23, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: STU-2019-1782

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No