Brief Video-Based Mindful Movement Intervention Prior to Pelvic Exams

NCT ID: NCT04728503

Last Updated: 2021-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-08
• Study Completion Date: 2021-04-01

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.

Conditions

Anxiety State; Pain; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

5-Minute Mindful Movement Video

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

Group Type: EXPERIMENTAL

5-Minute Mindful Movement Video

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Written Educative Materials

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Written Educative Materials

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Tracy Greer

Associate Professor, Department of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tracy Greer, PhD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

UT Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU-2019-1782

Identifier Type: -

Identifier Source: org_study_id