Sexual HarassmentNCT04139720
Sexual Harassment Prevention for Nursing Via E-Book
A study testing e-book in people with Sexual Harassment, run by China Medical University Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sexual Harassment
- What is being tested?
- e-book
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2019to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age over 20 years old
- Nursing school graduation
- full time job
Who cannot join
- Not directly in contact with the patient, such as the supply room
- Not engaged in nursing clinical work, such as research assistants
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the detailed description
- 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.
- 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.
- 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
- Conditions
- Sexual Harassment
- Being tested
- e-book
- Keywords
- sexual harassment prevention, nurse, education, e-book
- Medical subject headings
- Sexual Harassment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-bookBehavioural
sexual harassment prevention via education e-book
| Study group | Role | What they receive |
|---|---|---|
| e-book | Experimental | e-book learning mode of sexual harassment prevention training Receives: Behavioral: e-book |
| audio-visual and booklet | No intervention | sexual harassment prevention audio-visual and booklet learning mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
sexual harassment prevention knowledge
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.
Measured: The experimental group and the control group will take the test after the intervention immediately.
sexual harassment event coping skill
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).
Measured: The experimental group and the control group will take the test after the intervention immediately.
sexual harassment incident management
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
Measured: The experimental group and the control group will take the test after the intervention immediately.
Secondary outcomes (1)
Include learning motivation of sexual harassment
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.
Measured: The experimental group and the control group will take the test after the intervention immediately.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start15 Oct 2019 (estimated)
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexual HarassmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Ling Tzeng, China Medical University Hospital
- Investigators
- Ya-Ling Tzeng, PhD, Principal investigator, China Medical University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139720
- Sponsor's protocol ID
- CMUH108-REC1-086
- Status last verified
- Oct 2019
- First submitted
- 21 Oct 2019
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chang TS, Tzeng YL, Teng YK, Chen CH. Effectiveness of an e-book in enhancing knowledge, coping behaviors and preventive strategies for sexual harassment prevention among new nurses: A randomized controlled study. Nurse Educ Pract. 2025 Jan;82:104198. doi: 10.1016/j.nepr.2024.104198. Epub 2024 Nov 22.
PubMed 39612767
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Effectiveness Verification of Sexual Harassment Prevention Via Education E-Book for Nursing: Randomized Controlled Experiments
- ClinicalTrials.gov ID
- NCT04139720
- Acronym / sponsor ID
- CMUH108-REC1-086
- Conditions
- Sexual Harassment
- Keywords
- sexual harassment prevention, nurse, education, e-book
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 15 Oct 2019 (estimated)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 25 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| e-book | Experimental | Behavioral: e-booke-book learning mode of sexual harassment prevention training |
| audio-visual and booklet | No intervention | –sexual harassment prevention audio-visual and booklet learning mode |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 20 years old
- Nursing school graduation
- full time job
Key exclusion criteria (2 listed)
- Not directly in contact with the patient, such as the supply room
- Not engaged in nursing clinical work, such as research assistants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-booksexual harassment prevention via education e-book | Behavioural | e-book |
Primary outcome
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.
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).
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
1 secondary outcome
Include learning motivation of sexual harassment
Time frame: The experimental group and the control group will take the test after the intervention immediately.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- Derived from this study: PubMed 39612767Chang TS, Tzeng YL, Teng YK, Chen CH. Effectiveness of an e-book in enhancing knowledge, coping behaviors and preventive strategies for sexual harassment prevention among new nurses: A randomized controlled study. Nurse Educ Pract. 2025 Jan;82:104198. doi: 10.1016/j.nepr.2024.104198. Epub 2024 Nov 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ya-Ling Tzeng, PhD principal investigator
China Medical University, Taiwan
Questions about this trial
What is this clinical trial studying?
A study testing e-book in people with Sexual Harassment, run by China Medical University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting-shan chang, BSN (04-22053366 ext. 7112, u104077804@cmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sexual harassment prevention knowledge (time frame: The experimental group and the control group will take the test after the intervention immediately.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04139720, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2019; AzTrials last refreshed its copy on 1 Nov 2026.