Sexual Harassment Prevention for Nursing Via E-Book

October 23, 2019 updated by: Ya-Ling Tzeng, China Medical University Hospital

Development and Effectiveness Verification of Sexual Harassment Prevention Via Education E-Book for Nursing: Randomized Controlled Experiments

Nursing staff work closely with people and often have direct physical contact with patients, hence, they are high-risk individuals of sexual harassment. In particular for inexperienced newly employed nurses, if sexual harassment happened and without appropriate management, it may negatively impact physical and mental health, and even affect their willingness to engage in nursing field in the future. Therefore, how to assist the newly employed nurses to have the knowledge and ability to deal with sexual harassment in the workplace is important. Based on this, this study aims to improve the knowledge and practical ability of sexual harassment prevention, and develop "newly employed nurses' sexual harassment prevention training e-book" to implement gender perspective into nursing education which is in line with nursing clinical practice. The experimental research design is randomized controlled repeated measures; compare the differences between the two groups before and after the study to verify the effectiveness of the intervention. Overall, if it is proved effective, which will be able to enhance newly employed nurses' awareness of clinical sexual harassment and the ability to handle related incidents. The development of sexual harassment prevention materials can become a learning aid for nursing education. In addition to helping to reduce the adverse effects of sexual harassment in the nursing workplace, it will also help to establish the attention and consensus of the nursing profession on sexual harassment prevention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. Research design: The repeated measurements randomization control trial is used for the study design. We design a 45-minute course and 15 minutes Q&A to enable learners to integrate knowledge and experience to achieve meaningful and valuable learning experiences by exploring problems, summarizing and integrating information and expression. After the end of the study, quantitative analysis was used to compare the differences between the experimental group and the control group before and after the study and two weeks later to verify the effectiveness of different learning models. In order to avoid the difference between the retest effect and the practice effect, the second post-test will be performed two weeks after the pre-test to balance the bias caused by the test tool. They used different learning models. The experimental group used the e-book learning mode of sexual harassment prevention training, the control group used the sexual harassment prevention audio-visual learning mode, the dependent variable is the sexual harassment prevention knowledge, and the sexual harassment event coping skill, sexual harassment incident management and sexual harassment learning motivation.
  2. Randomization Process: The study used block randomization, and randomly assign participants who meet the selection criteria to the experimental group and the control group (1:1 ratio) by Random Allocation Software random assignment table. In addition, using the electronic form system, participants fill in the study number to replace the identifiable name, and then the research assistant uses the random distribution software to obtain a random assignment table, and use the table to allocate experimental and control group before the experiment. The sealed envelopes numbered 1 to 104 were arranged in the order of the groups. On the day of the study, the researchers take out the envelopes and assigned them to the participants according to the order of handing in the consents. Based on the group number (1 or 2) on the envelope bag, participants enter the designated meeting room for research.
  3. Sample size calculation: This study uses the repeated measures of G-Power 3.1.9 windows and between factors among groups to calculate the sample size. According to the predecessor study, the power value is set to .8, the alpha value is set to .05, and the effect size (ES) value is .25 (moderate ES). The number of samples was 43 in the experimental group and 43 in the control group, a total of 86. If the loss rate was 20%, the total requirement participants are 104. According to the literature, male nursing staff accounted for around 3%, so 4 of them were male nurses.

sexual harassment coping skill

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age over 20 years old
  2. Nursing school graduation
  3. full time job

Exclusion Criteria:

  1. Not directly in contact with the patient, such as the supply room
  2. Not engaged in nursing clinical work, such as research assistants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: e-book
e-book learning mode of sexual harassment prevention training
Behavioral: e-book
sexual harassment prevention via education e-book
No Intervention: audio-visual and booklet
sexual harassment prevention audio-visual and booklet learning mode

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
sexual harassment prevention knowledge
Time Frame: The experimental group and the control group will take the test after the intervention immediately.
using Likert seven-point scale, scoring from 7 (totally agree) to 1 (totally disagree), the score range from 16-112 points, the higher the total score of the scale, the better the understanding of harassment prevention concept.
The experimental group and the control group will take the test after the intervention immediately.
sexual harassment event coping skill
Time Frame: The experimental group and the control group will take the test after the intervention immediately.
Includes: Enhancing personal processing coping strategies for sexual harassment (4 questions), strengthening personal awareness and monitoring systems (13 questions), and strengthening social organization and policy development (14 questions). The scoring method: 0 (totally disagree) to 4 (very agree).
The experimental group and the control group will take the test after the intervention immediately.
sexual harassment incident management
Time Frame: The experimental group and the control group will take the test after the intervention immediately.
The scale is divided into verbal and non-verbal parts, which are summarized into three categories, namely, problem-solving, emotion and evaluation part, which total 37 questions according to the different attributes of the corresponding behavior. A score of 0 means never to 4 part means to always do 4 points means it always is. A higher score indicates that the more often new nursing might we to react
The experimental group and the control group will take the test after the intervention immediately.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Include learning motivation of sexual harassment
Time Frame: The experimental group and the control group will take the test after the intervention immediately.
Contains the learner's attention to the teaching material (12 questions), relevance (9 questions), confidence (9 questions), satisfaction (6 questions) and other learning motivation, a total of 36 questions, use Likert five-point scale, scoring method from 5 (very agreeable) to 1 (very disagree), the score range from 36-180 points, the higher the total score of the scale, the stronger the motivation of learning.
The experimental group and the control group will take the test after the intervention immediately.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China Medical University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ya-Ling Tzeng, PhD, China Medical University, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 25, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CMUH108-REC1-086

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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