Trial of a Patient Education Tool For Leiomyoma (PETAL)

Loyola University

Status: Completed

Conditions: Uterine Leiomyoma

Treatments: Behavioral: iPad counseling; Behavioral: Standard Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT03847077

207033

Details and patient eligibility

About

The goal of this study was to assess whether using a multimedia tool would enhance patient education and counseling on uterine leiomyomata.

Full 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.

Enrollment: 72 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

iPad counseling

Experimental group

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 multimedia counseling using the drawMD OB/GYN iPad application

Treatment:

Behavioral: iPad counseling

Standard counseling

Active Comparator group

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 standard counseling.

Treatment:

Behavioral: Standard Counseling