Anxiety StateNCT04728503
Brief Video-Based Mindful Movement Intervention Prior to Pelvic Exams
A study testing 5-Minute Mindful Movement Video and Written Educative Materials in people with Anxiety State and Pain, run by University of Texas Southwestern Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety State, Pain, Depression
- What is being tested?
- 5-Minute Mindful Movement Video and Written Educative Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2020to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Age of 18+ years
- Scheduled physical evaluation including pelvic exam at UT Southwestern's Lowe Foundation Center for Women's Preventative Health Care.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- 5-Minute Mindful Movement Video, Written Educative Materials
- Medical subject headings
- Anxiety Disorders, Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-Minute Mindful Movement VideoBehavioural
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 MaterialsBehavioural
1 page written educative material about the benefits of mindfulness to serve as a control.
| Study group | Role | What they receive |
|---|---|---|
| 5-Minute Mindful Movement Video | Experimental | 5 minute mindful movement video watched in the exam room on an iPad Receives: 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 Receives: Behavioral: Written Educative Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: immediately after the procedure
Secondary outcomes (4)
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.
Measured: baseline, pre-intervention/procedure
Exam Satisfaction Survey
Assess overall patient satisfaction with exam, and likelihood to attend future appointments
Measured: immediately after the procedure
Mindfulness Perceptions Survey
Treatment group completes a survey regarding perceptions of mindfulness video
Measured: immediately after the procedure
Physician Experience Survey
Physician who completes the pelvic exam will rate their experience completing the pelvic exam
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start8 Dec 2020
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety StateStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tracy Greer, University of Texas Southwestern Medical Center
- Investigators
- Tracy Greer, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728503
- Sponsor's protocol ID
- STU-2019-1782
- Status last verified
- Apr 2021
- First submitted
- 11 Jan 2021
- Last updated
- 26 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not have a formal data sharing plan; however, if investigators are interested in using these data, they may contact us to determine if that may be possible.
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Video-Based Mindful Movement Intervention Prior to Pelvic Exams
- ClinicalTrials.gov ID
- NCT04728503
- Acronym / sponsor ID
- STU-2019-1782
- Conditions
- Anxiety State, Pain, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 28 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5-Minute Mindful Movement Video | Experimental | Behavioral: 5-Minute Mindful Movement Video5 minute mindful movement video watched in the exam room on an iPad |
| Written Educative Materials | Placebo comparator | Behavioral: Written Educative Materials1 page printed written educative material about mindfulness benefits read for 5 minutes in the exam room |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- Age of 18+ years
- Scheduled physical evaluation including pelvic exam at UT Southwestern's Lowe Foundation Center for Women's Preventative Health Care.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-Minute Mindful Movement Video5 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. | Behavioural | 5-Minute Mindful Movement Video |
| Written Educative Materials1 page written educative material about the benefits of mindfulness to serve as a control. | Behavioural | Written Educative Materials |
Primary outcome
Visual Analogue Scale - Anxiety 1 (Change in Anxiety)
Time frame: baseline, pre-intervention/procedure
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.
Visual Analogue Scale - Anxiety 2 (Change in Anxiety)
Time frame: immediately after the intervention
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.
Visual Analogue Scale - Anxiety 3 (Change in Anxiety)
Time frame: immediately after the procedure
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.
Visual Analogue Scale - Pain 1
Time frame: baseline, pre-intervention
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.
Visual Analogue Scale - Pain 2
Time frame: immediately after the procedure
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.
4 secondary outcomes
Patient Health Questionnaire (PHQ-9)
Time frame: baseline, pre-intervention/procedure
Exam Satisfaction Survey
Time frame: immediately after the procedure
Mindfulness Perceptions Survey
Time frame: immediately after the procedure
Physician Experience Survey
Time frame: immediately after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Individual participant dataSharing planned: No. We do not have a formal data sharing plan; however, if investigators are interested in using these data, they may contact us to determine if that may be possible.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracy Greer, PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-Minute Mindful Movement Video and Written Educative Materials in people with Anxiety State and Pain, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale - Anxiety 1 (Change in Anxiety) (time frame: baseline, pre-intervention/procedure). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.