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OpenTrials
Completed

NCT Number: NCT03847077

Trial of a Patient Education Tool For Leiomyoma

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

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Key information

Conditions

Uterine Leiomyoma Connective Tissue Diseases Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

iPad counseling

Behavioral

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.

Standard Counseling

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Loyola University

Other

Registry information

Official study title

Randomized Trial of a Patient Education Tool For Leiomyoma

Acronym: PETAL

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 20, 2019
Registry last updated
Feb 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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