Randomized Trial of a Patient Education Tool For Leiomyoma
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Uterine Leiomyoma
- Sponsor
- Loyola University
- Enrollment
- 72
- Primary Endpoint
- Change in patient knowledge scores
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The goal of this study was to assess whether using a multimedia tool would enhance patient education and counseling on uterine leiomyomata.
Detailed Description
Women with leiomyomata confirmed on imaging who presented as a new patient to the gynecology clinic at a single institution were randomized to receive either standard counseling or multimedia counseling using the drawMD OB/GYN iPad application. Participants completed a pre-counseling questionnaire, received the designated method of counseling, and then completed a post-counseling questionnaire.
Investigators
Linda Yang
MD, Associate Professor
Loyola University
Eligibility Criteria
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
- Not provided
Outcomes
Primary Outcomes
Change in patient knowledge scores
Time Frame: Day 1
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.
Patient satisfaction post-counseling
Time Frame: Day 1
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.
Patient anxiety pre-couseling
Time Frame: Day 1
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.
Patient anxiety post-couseling
Time Frame: Day 1
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.