Clinical trial NCT04728503: Brief Video-Based Mindful Movement Intervention Prior to Pelvic Exams
Official title: Brief Video-Based Mindful Movement Intervention Prior to Pelvic Exams
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety State
Pain
Depression
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Visual Analogue Scale - Anxiety 1 (Change in Anxiety)
timeFrame: baseline, pre-intervention/procedure
measure: Visual Analogue Scale - Anxiety 2 (Change in Anxiety)
timeFrame: immediately after the intervention
measure: Visual Analogue Scale - Anxiety 3 (Change in Anxiety)
timeFrame: immediately after the procedure
measure: Visual Analogue Scale - Pain 1
timeFrame: baseline, pre-intervention
measure: Visual Analogue Scale - Pain 2
timeFrame: immediately after the procedure
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: baseline, pre-intervention/procedure
measure: Exam Satisfaction Survey
timeFrame: immediately after the procedure
measure: Mindfulness Perceptions Survey
timeFrame: immediately after the procedure
measure: Physician Experience Survey
timeFrame: immediately after the procedure
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Tracy Greer, PhD
role: PRINCIPAL_INVESTIGATOR
References: