Uterine BleedingFibroid AUBNCT07072364
Videos to Aid Decision Making for Fibroid Treatment
A study testing Video on uterine fibroids in people with Uterine Bleeding and Decision Aid, run by University of Pennsylvania at 1 site in United States.
Trial summary
Uterine fibroids are a common condition that can cause heavy and/or painful menstrual bleeding. There are many treatment options, but they vary in efficacy, side effects, short-term recovery and long-term implications for future fertility. Patients can have difficulty deciding between these options. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Uterine Bleeding, Decision Aid
- What is being tested?
- Video on uterine fibroids
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2025to 5 Jul 2026
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of uterine fibroids
- Scheduled appointment to discuss management of fibroids in an outpatient clinical site associated with the Hospital of the University of Pennsylvania
Who cannot join
- Age <18 or >55
- Uterine or cervical cancer
- Cervical dysplasia grade 2-3 within the last 12 mo
- Pregnancy
- Menopause
- Decision made prior to the study intake to have a surgical procedure for treatment of fibroids
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19010
About this study
Official title: The Use of Video Aids Versus Usual Care for Reduction in Decisional Conflict in Fibroid Treatment
Uterine fibroids are a common condition that can cause heavy and/or painful menstrual bleeding. There are many treatment options, but they vary in efficacy, side effects, short-term recovery and long-term implications for future fertility. Patients can have difficulty deciding between these options. In this study, the investigators will randomly assign patients seeking treatment for fibroids to receive an educational video on fibroids and their treatment, versus usual care (no video). The investigators will assess their decisional conflict with and without exposure to the video using a validated survey to see if exposure to the educational video helps them make decisions.
Read the detailed description
Decisional conflict is defined as personal uncertainty regarding which course of action to take when choice among different options involves risk, regret, or challenge to personal life values. Some factors that influence decisional conflict are inadequate knowledge, unclear values, inadequate support, and the perception that an ineffective decision has been made. In this study, the investigators hope to target the factor of inadequate knowledge to see if an educational-style video can decrease decisional conflict in patients with fibroids. This will be completed via assessment using a validated decisional conflict scale score the DCS-10. DCS-10 scores range from 0 to 100 with a larger number indicating a higher level of decisional conflict. Scores above 37.5 are associated with decision delay. Through improving knowledge via an educational video about fibroids, the investigators wish to determine if decisional conflict can be minimized.
This will be a randomized, single-blinded trial. Patients in the intervention arm will be sent an educational video on fibroids prior to their visit to discuss fibroid treatment options. All patients will receive routine clinical care and counseling regarding treatment options at their visit. After the visit, patients will complete a DCS-10 survey. Survey instruments will be sent via text message using the Way to Health platform, timed to automatically send based on appointment date.
Pilot data shows an average post-visit DCS-10 score of 29 within this gynecologic population. With the recommended effect size of 0.4 in the literature on DCS-10, a sample size of 154 patients is needed. The investigators anticipate study recruitment will take approximately six months. Individual participation in the study will begin when patients are sent an invitation to participate soon after scheduling a visit to discuss fibroid treatment. It will end with a post-visit DCS-10 survey within one week of the visit. The survey will take approximately 5 minutes to complete and the video duration is 5 minutes, for a total of 10 minutes of participant time after enrollment. Based on the time between scheduling and completing this visit, the time between enrollment and final survey collection will be approximately 1-12 weeks. Chart review will occur to capture treatment decisions within 12 weeks of visit.
- Conditions
- Uterine Bleeding, Decision Aid
- Being tested
- Video on uterine fibroids
- Keywords
- Abnormal uterine bleeding, Uterine fibroids, Decisional Conflict Scale, Educational videos
- Medical subject headings
- Uterine Hemorrhage, Metrorrhagia, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video on uterine fibroidsBehavioural
Also called Video
Patients will be sent a link to a 5 minute video on uterine fibroids including their diagnosis, symptoms and treatment options prior to their scheduled appointment.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Patients will receive no additional education prior to their scheduled appointment to discuss uterine fibroids. |
| Video | Experimental | Patients in this arm will receive a 5 minute educational video regarding symptoms, diagnosis and management options of uterine fibroids prior to their scheduled outpatient visit. Receives: Behavioral: Video on uterine fibroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict Scale
Patients complete a 10 question Decisional Conflict Scale 10 Item Version (DCS-10) via text message up to 1 week after their completed appointment. Each of the 10 questions asks patients on a 0-5 Likert scale. Higher scores indicate more decisional conflict. Minimum score of 0 = no decisional conflict. Maximum score of 40 = high decisional conflict.
Measured: 1 weeks after appointment
Secondary outcomes (3)
Treatment selected
Patients will be assigned one of four treatment options based on documentation from initial consultation or from chart review within 12 weeks after appointment completion.
- Expectant management, defined as no medical or surgical intervention
- Medical management, defined as acceptance of prescribed medications such as oral contraceptive pills, GnRH modifiers (oral or injected), Injectable medications (such as Depo-Provera), Intrauterine devices.
- Surgical management, defined as myomectomy or hysterectomy.
- Other procedural management, defined as uterine artery embolization or high intensity focused ultrasound.
Measured: 12 weeks post appointment
Time to treatment
Patients time to selected treatment will be determined based on documentation within the medical chart with regards to acceptance of treatment.
- Expectant management group, based on documentation within the medical record from initial visit.
- Medical management group, based on the date of prescription of medication or date of documented decision for intrauterine device placement.
- Surgical management group, based on the date of decision for surgical intervention as confirmed by scheduled procedure in chart.
- Other procedural management group, based on the date of decision for management as confirmed by scheduled appointment in chart.
Measured: 12 weeks post appointment
Length of visit
Length of visit will be collected for all patients at baseline visit. This information is accessible by reviewing documented billing codes and documentation within the note from providers. Specifically for telehealth visits total minutes are available for all patients. If total time is not documented, pts will be assigned by level of visit billed to low end of the billable minutes.
Level 2 10-19 min (assigned time would be 10 min) Level 3 20-29 min (assigned time would be 20 min) Level 4 30-39 min (assigned time would be 30 min) Level 5 40-54 min (assigned time would be 50 min)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start12 Mar 2025
- Primary completion10 Jun 2026
- Study completion5 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine BleedingStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Single group
- Model description
- Patients will be randomized to either receive an educational video or not. The patients decisional conflict will be measured after receiving the intervention or not.
- Masking
- None (open label)
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- OptumRx
- Responsible party
- Sponsor
- Investigators
- Anuja Dokras, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072364
- Sponsor's protocol ID
- OBGYN-GYN-QI-1
- Acronym
- Fibroid AUB
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Privacy concerns, not applicable to primary outcome.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Video Aids Versus Usual Care for Reduction in Decisional Conflict in Fibroid Treatment
- ClinicalTrials.gov ID
- NCT07072364
- Acronym / sponsor ID
- Fibroid AUB / OBGYN-GYN-QI-1
- Conditions
- Uterine Bleeding, Decision Aid
- Keywords
- Abnormal uterine bleeding, Uterine fibroids, Decisional Conflict Scale, Educational videos
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- OptumRx
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 10 Jun 2026 (actual)
- Study completion
- 5 Jul 2026 (actual)
- First posted
- 18 Jul 2025 (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.
Uterine fibroids are a common condition that can cause heavy and/or painful menstrual bleeding. There are many treatment options, but they vary in efficacy, side effects, short-term recovery and long-term implications for future fertility. Patients can have difficulty deciding between these options. In this study, the investigators will randomly assign patients seeking treatment for fibroids to receive an educational video on fibroids and their treatment, versus usual care (no video). The investigators will assess their decisional conflict with and without exposure to the video using a validated survey to see if exposure to the educational video helps them make decisions.
Detailed description
Decisional conflict is defined as personal uncertainty regarding which course of action to take when choice among different options involves risk, regret, or challenge to personal life values. Some factors that influence decisional conflict are inadequate knowledge, unclear values, inadequate support, and the perception that an ineffective decision has been made. In this study, the investigators hope to target the factor of inadequate knowledge to see if an educational-style video can decrease decisional conflict in patients with fibroids. This will be completed via assessment using a validated decisional conflict scale score the DCS-10. DCS-10 scores range from 0 to 100 with a larger number indicating a higher level of decisional conflict. Scores above 37.5 are associated with decision delay. Through improving knowledge via an educational video about fibroids, the investigators wish to determine if decisional conflict can be minimized.
This will be a randomized, single-blinded trial. Patients in the intervention arm will be sent an educational video on fibroids prior to their visit to discuss fibroid treatment options. All patients will receive routine clinical care and counseling regarding treatment options at their visit. After the visit, patients will complete a DCS-10 survey. Survey instruments will be sent via text message using the Way to Health platform, timed to automatically send based on appointment date.
Pilot data shows an average post-visit DCS-10 score of 29 within this gynecologic population. With the recommended effect size of 0.4 in the literature on DCS-10, a sample size of 154 patients is needed. The investigators anticipate study recruitment will take approximately six months. Individual participation in the study will begin when patients are sent an invitation to participate soon after scheduling a visit to discuss fibroid treatment. It will end with a post-visit DCS-10 survey within one week of the visit. The survey will take approximately 5 minutes to complete and the video duration is 5 minutes, for a total of 10 minutes of participant time after enrollment. Based on the time between scheduling and completing this visit, the time between enrollment and final survey collection will be approximately 1-12 weeks. Chart review will occur to capture treatment decisions within 12 weeks of visit.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized to either receive an educational video or not. The patients decisional conflict will be measured after receiving the intervention or not.
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Patients will receive no additional education prior to their scheduled appointment to discuss uterine fibroids. |
| Video | Experimental | Behavioral: Video on uterine fibroidsPatients in this arm will receive a 5 minute educational video regarding symptoms, diagnosis and management options of uterine fibroids prior to their scheduled outpatient visit. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of uterine fibroids
- Scheduled appointment to discuss management of fibroids in an outpatient clinical site associated with the Hospital of the University of Pennsylvania
Key exclusion criteria (6 listed)
- Age <18 or >55
- Uterine or cervical cancer
- Cervical dysplasia grade 2-3 within the last 12 mo
- Pregnancy
- Menopause
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 |
|---|---|---|
| Video on uterine fibroidsAlso: VideoPatients will be sent a link to a 5 minute video on uterine fibroids including their diagnosis, symptoms and treatment options prior to their scheduled appointment. | Behavioural | Video |
Primary outcome
Decisional Conflict Scale
Time frame: 1 weeks after appointment
Patients complete a 10 question Decisional Conflict Scale 10 Item Version (DCS-10) via text message up to 1 week after their completed appointment. Each of the 10 questions asks patients on a 0-5 Likert scale. Higher scores indicate more decisional conflict. Minimum score of 0 = no decisional conflict. Maximum score of 40 = high decisional conflict.
3 secondary outcomes
Treatment selected
Time frame: 12 weeks post appointment
Time to treatment
Time frame: 12 weeks post appointment
Length of visit
Time frame: Baseline
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 3 Sep 2026.
- Individual participant dataSharing planned: No. Privacy concerns, not applicable to primary outcome.
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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.
Anuja Dokras, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video on uterine fibroids in people with Uterine Bleeding and Decision Aid, run by University of Pennsylvania 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 2 inclusion and 6 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 3 Sep 2026. 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. 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?
Decisional Conflict Scale (time frame: 1 weeks after appointment). 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 3 Sep 2026.