Brief Video-Based Mindful Movement Intervention Prior to Pelvic Exams

Depression Clinical Trial

Official title:

Brief Video-Based Mindful Movement Intervention Prior to Pelvic Exams

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04728503
• Other study ID #: STU-2019-1782
• Status: Completed
• Phase: N/A
• Start date: December 8, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: April 2021
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety State
• Depression
• Pain

Intervention

Behavioral:
• 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.
• Written Educative Materials
1 page written educative material about the benefits of mindfulness to serve as a control.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Patient Health Questionnaire (PHQ-9)	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.	baseline, pre-intervention/procedure
Secondary	Exam Satisfaction Survey	Assess overall patient satisfaction with exam, and likelihood to attend future appointments	immediately after the procedure
Secondary	Mindfulness Perceptions Survey	Treatment group completes a survey regarding perceptions of mindfulness video	immediately after the procedure
Secondary	Physician Experience Survey	Physician who completes the pelvic exam will rate their experience completing the pelvic exam	immediately after the procedure