Brief Video-Based Mindful Movement Intervention Prior to Pelvic Exams

The University of Texas System (UT)

Status: Completed

Conditions: Depression; Pain; Anxiety State

Treatments: Behavioral: Written Educative Materials; Behavioral: 5-Minute Mindful Movement Video

Study type: Interventional

Funder types: Other

Identifiers

NCT04728503

STU-2019-1782

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

5-Minute Mindful Movement Video

Experimental group

Description:

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

Treatment:

Behavioral: 5-Minute Mindful Movement Video

Written Educative Materials

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Written Educative Materials