Uterine Leiomyoma Clinical Trial
— PETALOfficial title:
Randomized Trial of a Patient Education Tool For Leiomyoma
Verified date | February 2019 |
Source | Loyola University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this study was to assess whether using a multimedia tool would enhance patient education and counseling on uterine leiomyomata.
Status | Completed |
Enrollment | 72 |
Est. completion date | October 31, 2018 |
Est. primary completion date | October 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Non-pregnant - English speaking - Women aged 18-60 years - presence of fibroids confirmed on imaging - no confirmed or suspicion of malignancy Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Loyola University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in patient knowledge scores | Patients were asked baseline knowledge questions about fibroids prior to receiving physician counseling. Patients were randomized to iPad counseling or standard counseling groups. After the counseling session, patients answered similar knowledge questions about fibroids. The pre-counseling and post-counseling scores will be compared for each group. Generalized estimating equations were used to test whether any change in knowledge from pre-counseling to post-counseling was dependent on the participant's intervention assignment. | Day 1 | |
Primary | Patient satisfaction post-counseling | Patients completed a Likert scale questionnaire (1 = Very Dissatisfied, 2 = Dissatisfied, 3 = Neutral, 4 = Satisfied, 5 = Extremely Satisfied) to evaluate satisfaction with assigned counseling method. | Day 1 | |
Primary | Patient anxiety pre-couseling | Participants completed a Likert scale questionnaire (1 = Not at all, 2 = Somewhat, 3 = Moderately, 4 = Very Much) about their anxiety related to fibroids prior to receiving physician counseling. | Day 1 | |
Primary | Patient anxiety post-couseling | Participants completed a Likert scale questionnaire (1 = Not at all, 2 = Somewhat, 3 = Moderately, 4 = Very Much) about their anxiety related to fibroids after receiving physician counseling. | Day 1 |
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