Clinical trial NCT04139720: Sexual Harassment Prevention for Nursing Via E-Book
Official title: Development and Effectiveness Verification of Sexual Harassment Prevention Via Education E-Book for Nursing: Randomized Controlled Experiments
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sexual Harassment
Keywords: sexual harassment prevention
nurse
education
e-book
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 104
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The repeated measurements randomization control trial will be used for the experimental design. We design a 45-minute course and 15 minutes of Q\&A. Based on the gender in recruitment, 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.
Primary purpose: OTHER

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: sexual harassment prevention knowledge
timeFrame: The experimental group and the control group will take the test after the intervention immediately.
measure: sexual harassment event coping skill
timeFrame: The experimental group and the control group will take the test after the intervention immediately.
measure: sexual harassment incident management
timeFrame: The experimental group and the control group will take the test after the intervention immediately.
Secondary outcomes:
measure: Include learning motivation of sexual harassment
timeFrame: The experimental group and the control group will take the test after the intervention immediately.
Other outcomes:
Locations:
Study officials:
affiliation: China Medical University, Taiwan
name: Ya-Ling Tzeng, PhD
role: PRINCIPAL_INVESTIGATOR
References: