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Completed

NCT Number: NCT04728503

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.

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Key information

Conditions

Anxiety State Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

5-Minute Mindful Movement Video

Behavioral

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.

Written Educative Materials

Behavioral

1 page written educative material about the benefits of mindfulness to serve as a control.

Primary outcomes

  1. Visual Analogue Scale - Anxiety 1 (Change in Anxiety)

    Time frame: baseline, pre-intervention/procedure

    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.

  2. Visual Analogue Scale - Anxiety 2 (Change in Anxiety)

    Time frame: immediately after the intervention

    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.

  3. Visual Analogue Scale - Anxiety 3 (Change in Anxiety)

    Time frame: immediately after the procedure

    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.

  4. Visual Analogue Scale - Pain 1

    Time frame: baseline, pre-intervention

    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.

  5. Visual Analogue Scale - Pain 2

    Time frame: immediately after the procedure

    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 outcomes

  1. Patient Health Questionnaire (PHQ-9)

    Time frame: baseline, pre-intervention/procedure

    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.

  2. Exam Satisfaction Survey

    Time frame: immediately after the procedure

    Assess overall patient satisfaction with exam, and likelihood to attend future appointments

  3. Mindfulness Perceptions Survey

    Time frame: immediately after the procedure

    Treatment group completes a survey regarding perceptions of mindfulness video

  4. Physician Experience Survey

    Time frame: immediately after the procedure

    Physician who completes the pelvic exam will rate their experience completing the pelvic exam

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 28, 2021
Registry last updated
Apr 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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