Brief Video-Based Mindful Movement Intervention Prior to Pelvic Exams

NCT04728503 | Completed

• 1 other identifier: STU-2019-1782
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety State; Pain; Depression

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Patient Health Questionnaire (PHQ-9)

  baseline, pre-intervention/procedure

• Exam Satisfaction Survey

  immediately after the procedure

• Mindfulness Perceptions Survey

  immediately after the procedure

• Physician Experience Survey

  immediately after the procedure

Study Arms (2)

5-Minute Mindful Movement Video

EXPERIMENTAL

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

Behavioral: 5-Minute Mindful Movement Video

Written Educative Materials

PLACEBO COMPARATOR

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

Behavioral: Written Educative Materials

Interventions

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.

5-Minute Mindful Movement Video

Written Educative Materials BEHAVIORAL

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

Written Educative Materials

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Tracy Greer, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Psychiatry

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 28, 2021
• Study Start: December 8, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)