Child Sexual AbuseNCT06497803
The Effect of Nurse-Led Body Protection Education in Students With Visual Impairments
A study testing Nurse-Led Body Protection Education and Reminder Education Brochure in people with Child Sexual Abuse and Disability, Vision, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
In the study, it was aimed to examine the effect of nurse-led body protection education on the sexual abuse knowledge levels of students with visual impairments. Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Sexual Abuse, Disability, Vision
- What is being tested?
- Nurse-Led Body Protection Education and Reminder Education Brochure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Oct 2021to 7 Jan 2022
- 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 7 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students with visual impairments who gave their consent to participate in the study and who could communicate in Turkish were included in the study.
Who cannot join
- Students who had a mental disability in addition to visual impairment were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Nurse-Led Body Protection Education on the Sexual Abuse Knowledge Levels of Students With Visual Impairments: A Randomized Controlled Trial
In the study, it was aimed to examine the effect of nurse-led body protection education on the sexual abuse knowledge levels of students with visual impairments.
Read the detailed description
Children with visual impairments form a risky group in terms of abuse as they are more dependent in relation to providing self-care compared to children with visually healthy and they use their sense of touch in communicating with the environment. The 53 students with visual impairments were randomly assigned to the intervention group and the control group. The study data were collected through children's knowledge of abuse questionnaire - revised with the subdimensions of good touch and bad touch. Nurse-led body protection education was provided to the intervention group in groups of 3-4 in 40 minutes. The education was provided as verbal narration by using a doll and distress whistle. In addition, two weeks after the post-test, a reminder education brochure prepared with the braille alphabet was distributed to the students in the intervention group.
- Conditions
- Child Sexual Abuse, Disability, Vision
- Being tested
- Nurse-Led Body Protection Education, Reminder Education Brochure
- Keywords
- Child sexual abuse, Visually impaired children, Prevention, Health education, Public health nursing
- Medical subject headings
- Vision Disorders, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Led Body Protection EducationOther
Also called NLBPE
Based on BST and Safe Touches education programs and in line with the studies conducted in the literature on children who are not visually impaired, NLBPE was created by the researchers (Akgul et al., 2021; Citak-Tunc et al., 2018; Pulido, 2019; Wurtele, 2007). The program aims to teach visually impaired children how to protect the private parts of their bodies, to distinguish between good and bad touch, to distinguish between good and bad secrets, to say no, scream, and ask for help when necessary. As education tools, dolls and distress whistles were used. In order for children to learn the private parts of their bodies, a doll was used. The practice of "Say No, Scream, Run, and Blow Your Whistle While Running" in order for the students to protect their body from bad touch was applied by the students one by one firstly, and in groups later.
Reminder Education BrochureOther
Also called REB
The brochure was prepared in line with the NLBPE and included what is a good touch and a bad touch, how to distinguish a good touch from a bad touch, examples of good touch and bad touch, and what to do when encountered with a bad touch (Say No, Scream, Run, and Blow Your Whistle While Running). The brochure, the content of which was prepared by the researcher, was translated into Braille Alphabet by a visually impaired teacher working at the school where the research was conducted, before it was distributed to the intervention group members.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Nurse-led body protection education was provided to the intervention group in groups of 3-4 in 40 minutes. The education was provided as verbal narration by using a doll and distress whistle. In addition, two weeks after the post-test, a reminder education brochure prepared with the braille alphabet was distributed to the students in the intervention group. Receives: Other: Nurse-Led Body Protection Education; Other: Reminder Education Brochure |
| Control Group | No intervention | Pretest, posttest and follow-up test were applied simultaneously to the intervention group and the control group. Throughout the research, the control group continued their routine education. After the follow-up test, the control group was also provided with nurse-led body protection education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Good Touch subscale of the Children's Knowledge of Abuse Questionnaire-Revised scale
The Good Touch subscale of the Children's Knowledge of Abuse Questionnaire-Revised scale was applied in the pre-test, post-test and follow-up test. The scale was developed by Tutty in 1992 and finalized by revising in 1995 (Tutty, 1997). The Turkish adaptation study of the scale was conducted by Yilmaz and Cenkseven-Onder (2020). Eight items on the scale (1, 3, 8, 17, 20, 25, 27 and 30) are under the Good Touch subdimension. The responses to the items are in the form of Correct, Incorrect, and Don't Know. In the analysis of the scale, "correct" answers are scored as 1 point, and "incorrect" and "Don't Know" responses are scored as 0 point.
Measured: Change in knowledge level within two months
The Bad Touch subscale of the Children's Knowledge of Abuse Questionnaire-Revised scale
The Bad Touch subscale of the Children's Knowledge of Abuse Questionnaire-Revised scale was applied in the pre-test, post-test and follow-up test. The scale was developed by Tutty in 1992 and finalized by revising in 1995 (Tutty, 1997). The Turkish adaptation study of the scale was conducted by Yilmaz and Cenkseven-Onder (2020). 22 items are under the Bad Touch subdimension. The responses to the items are in the form of Correct, Incorrect, and Don't Know. In the analysis of the scale, "correct" answers are scored as 1 point, and "incorrect" and "Don't Know" responses are scored as 0 point.
Measured: Change in knowledge level within two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start8 Oct 2021
- Primary completion26 Nov 2021
- Study completion7 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Child Sexual AbuseStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is parallel group randomized controlled study.
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayse Ergun, Prof, Study chair, Marmara UniversityEsma Akgul, MSc, RN, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497803
- Sponsor's protocol ID
- 09.2020.172
- Status last verified
- Jul 2024
- First submitted
- 5 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cecen-Erogul AR, Kaf Hasirci O. The effectiveness of psycho-educational school-based child sexual abuse prevention training program on turkish elementary students. Educational Sciences: Theory and Practice. 2013; 13(2): 725-729.
Jin Y, Chen J, Jiang Y, Yu B. Evaluation of a sexual abuse prevention education program for school-age children in China: a comparison of teachers and parents as instructors. Health Educ Res. 2017 Aug 1;32(4):364-373. doi: 10.1093/her/cyx047.
PubMed 28854573Huang S, Cui C. Preventing Child Sexual Abuse Using Picture Books: The Effect of Book Character and Message Framing. J Child Sex Abus. 2020 May-Jun;29(4):448-467. doi: 10.1080/10538712.2020.1719449. Epub 2020 Feb 28.
PubMed 32109197Czerwinski F, Finne E, Alfes J, Kolip P. Effectiveness of a school-based intervention to prevent child sexual abuse-Evaluation of the German IGEL program. Child Abuse Negl. 2018 Dec;86:109-122. doi: 10.1016/j.chiabu.2018.08.023. Epub 2018 Oct 1.
PubMed 30278285Manheim M, Felicetti R, Moloney G. Child Sexual Abuse Victimization Prevention Programs in Preschool and Kindergarten: Implications for Practice. J Child Sex Abus. 2019 Aug-Sep;28(6):745-757. doi: 10.1080/10538712.2019.1627687. Epub 2019 Jun 20.
PubMed 31219780Pulido ML, Dauber S, Tully BA, Hamilton P, Smith MJ, Freeman K. Knowledge Gains Following a Child Sexual Abuse Prevention Program Among Urban Students: A Cluster-Randomized Evaluation. Am J Public Health. 2015 Jul;105(7):1344-50. doi: 10.2105/AJPH.2015.302594. Epub 2015 May 14.
PubMed 25973809White C, Shanley DC, Zimmer-Gembeck MJ, Walsh K, Hawkins R, Lines K, Webb H. Promoting young children's interpersonal safety knowledge, intentions, confidence, and protective behavior skills: Outcomes of a randomized controlled trial. Child Abuse Negl. 2018 Aug;82:144-155. doi: 10.1016/j.chiabu.2018.05.024. Epub 2018 Jun 11.
PubMed 29902697Wurtele SK. Teaching young children personal body safety. The Body Safety Training Workbook. 2007. University of Colorado: Colorado Springs.
Akgül E, Darak S, Sisman FN, Ergun A. Effect of the Nurse-Led. Journal of Psychiatric Nursing. 2021; 12(2): 156-164.
Citak Tunc G, Gorak G, Ozyazicioglu N, Ak B, Isil O, Vural P. Preventing Child Sexual Abuse: Body Safety Training for Young Children in Turkey. J Child Sex Abus. 2018 May-Jun;27(4):347-364. doi: 10.1080/10538712.2018.1477001. Epub 2018 Jun 1.
PubMed 29856274Irmak TY, Kızıltepe R, Aksel Ş, Güngör D, Eslek D. Mika ile kendimi korumayı öğreniyorum: Cinsel istismarı önleme programının etkililiği ["I am learning to protect myself with Mika": The effectiveness of a sexual abuse prevention program]. Türk Psikoloji Dergisi. 2018; 33(81): 41-61.
Warraitch A, Amin R, Rashid A. Evaluation of a school-based sexual abuse prevention program for female children with intellectual disabilities in rural Pakistan- A feasibility study. Appl Nurs Res. 2021 Feb;57:151391. doi: 10.1016/j.apnr.2020.151391. Epub 2020 Nov 25.
PubMed 33549294Bustamante G, Andrade MS, Mikesell C, Cullen C, Endara P, Burneo V, Yepez P, Avila Saavedra S, Ponce P, Grunauer M. "I have the right to feel safe": Evaluation of a school-based child sexual abuse prevention program in Ecuador. Child Abuse Negl. 2019 May;91:31-40. doi: 10.1016/j.chiabu.2019.02.009. Epub 2019 Feb 26.
PubMed 30822629Kim SJ, Kang KA. Effects of the Child Sexual Abuse Prevention Education (C-SAPE) Program on South Korean Fifth-Grade Students' Competence in Terms of Knowledge and Self-Protective Behaviors. J Sch Nurs. 2017 Apr;33(2):123-132. doi: 10.1177/1059840516664182. Epub 2016 Sep 20.
PubMed 27573418Jones C, Scholes L, Rolfe B, Stieler-Hunt C. A serious-game for child sexual abuse prevention: An evaluation of orbit. Child Abuse Negl. 2020 Sep;107:104569. doi: 10.1016/j.chiabu.2020.104569. Epub 2020 Jun 11.
PubMed 32535338
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nurse-Led Body Protection Education on the Sexual Abuse Knowledge Levels of Students With Visual Impairments: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06497803
- Acronym / sponsor ID
- 09.2020.172
- Conditions
- Child Sexual Abuse, Disability, Vision
- Keywords
- Child sexual abuse, Visually impaired children, Prevention, Health education, Public health nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 26 Nov 2021 (actual)
- Study completion
- 7 Jan 2022 (actual)
- First posted
- 12 Jul 2024 (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.
In the study, it was aimed to examine the effect of nurse-led body protection education on the sexual abuse knowledge levels of students with visual impairments.
Detailed description
Children with visual impairments form a risky group in terms of abuse as they are more dependent in relation to providing self-care compared to children with visually healthy and they use their sense of touch in communicating with the environment. The 53 students with visual impairments were randomly assigned to the intervention group and the control group. The study data were collected through children's knowledge of abuse questionnaire - revised with the subdimensions of good touch and bad touch. Nurse-led body protection education was provided to the intervention group in groups of 3-4 in 40 minutes. The education was provided as verbal narration by using a doll and distress whistle. In addition, two weeks after the post-test, a reminder education brochure prepared with the braille alphabet was distributed to the students in the intervention group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is parallel group randomized controlled study.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Nurse-Led Body Protection Education, Other: Reminder Education BrochureNurse-led body protection education was provided to the intervention group in groups of 3-4 in 40 minutes. The education was provided as verbal narration by using a doll and distress whistle. In addition, two weeks after the post-test, a reminder education brochure prepared with the braille alphabet was distributed to the students in the intervention group. |
| Control Group | No intervention | –Pretest, posttest and follow-up test were applied simultaneously to the intervention group and the control group. Throughout the research, the control group continued their routine education. After the follow-up test, the control group was also provided with nurse-led body protection education. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Students with visual impairments who gave their consent to participate in the study and who could communicate in Turkish were included in the study.
Key exclusion criteria (1 listed)
- Students who had a mental disability in addition to visual impairment were excluded from the study.
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 |
|---|---|---|
| Nurse-Led Body Protection EducationAlso: NLBPEBased on BST and Safe Touches education programs and in line with the studies conducted in the literature on children who are not visually impaired, NLBPE was created by the researchers (Akgul et al., 2021; Citak-Tunc et al., 2018; Pulido, 2019; Wurtele, 2007). The program aims to teach visually impaired children how to protect the private parts of their bodies, to distinguish between good and bad touch, to distinguish between good and bad secrets, to say no, scream, and ask for help when necessary. As education tools, dolls and distress whistles were used. In order for children to learn the private parts of their bodies, a doll was used. The practice of "Say No, Scream, Run, and Blow Your Whistle While Running" in order for the students to protect their body from bad touch was applied by the students one by one firstly, and in groups later. | Other | Intervention Group |
| Reminder Education BrochureAlso: REBThe brochure was prepared in line with the NLBPE and included what is a good touch and a bad touch, how to distinguish a good touch from a bad touch, examples of good touch and bad touch, and what to do when encountered with a bad touch (Say No, Scream, Run, and Blow Your Whistle While Running). The brochure, the content of which was prepared by the researcher, was translated into Braille Alphabet by a visually impaired teacher working at the school where the research was conducted, before it was distributed to the intervention group members. | Other | Intervention Group |
Primary outcome
The Good Touch subscale of the Children's Knowledge of Abuse Questionnaire-Revised scale
Time frame: Change in knowledge level within two months
The Good Touch subscale of the Children's Knowledge of Abuse Questionnaire-Revised scale was applied in the pre-test, post-test and follow-up test. The scale was developed by Tutty in 1992 and finalized by revising in 1995 (Tutty, 1997). The Turkish adaptation study of the scale was conducted by Yilmaz and Cenkseven-Onder (2020). Eight items on the scale (1, 3, 8, 17, 20, 25, 27 and 30) are under the Good Touch subdimension. The responses to the items are in the form of Correct, Incorrect, and Don't Know. In the analysis of the scale, "correct" answers are scored as 1 point, and "incorrect" and "Don't Know" responses are scored as 0 point.
The Bad Touch subscale of the Children's Knowledge of Abuse Questionnaire-Revised scale
Time frame: Change in knowledge level within two months
The Bad Touch subscale of the Children's Knowledge of Abuse Questionnaire-Revised scale was applied in the pre-test, post-test and follow-up test. The scale was developed by Tutty in 1992 and finalized by revising in 1995 (Tutty, 1997). The Turkish adaptation study of the scale was conducted by Yilmaz and Cenkseven-Onder (2020). 22 items are under the Bad Touch subdimension. The responses to the items are in the form of Correct, Incorrect, and Don't Know. In the analysis of the scale, "correct" answers are scored as 1 point, and "incorrect" and "Don't Know" responses are scored as 0 point.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- BackgroundCecen-Erogul AR, Kaf Hasirci O. The effectiveness of psycho-educational school-based child sexual abuse prevention training program on turkish elementary students. Educational Sciences: Theory and Practice. 2013; 13(2): 725-729.
- Background: PubMed 28854573Jin Y, Chen J, Jiang Y, Yu B. Evaluation of a sexual abuse prevention education program for school-age children in China: a comparison of teachers and parents as instructors. Health Educ Res. 2017 Aug 1;32(4):364-373. doi: 10.1093/her/cyx047.
- Background: PubMed 32109197Huang S, Cui C. Preventing Child Sexual Abuse Using Picture Books: The Effect of Book Character and Message Framing. J Child Sex Abus. 2020 May-Jun;29(4):448-467. doi: 10.1080/10538712.2020.1719449. Epub 2020 Feb 28.
- Background: PubMed 30278285Czerwinski F, Finne E, Alfes J, Kolip P. Effectiveness of a school-based intervention to prevent child sexual abuse-Evaluation of the German IGEL program. Child Abuse Negl. 2018 Dec;86:109-122. doi: 10.1016/j.chiabu.2018.08.023. Epub 2018 Oct 1.
- Background: PubMed 31219780Manheim M, Felicetti R, Moloney G. Child Sexual Abuse Victimization Prevention Programs in Preschool and Kindergarten: Implications for Practice. J Child Sex Abus. 2019 Aug-Sep;28(6):745-757. doi: 10.1080/10538712.2019.1627687. Epub 2019 Jun 20.
- Background: PubMed 25973809Pulido ML, Dauber S, Tully BA, Hamilton P, Smith MJ, Freeman K. Knowledge Gains Following a Child Sexual Abuse Prevention Program Among Urban Students: A Cluster-Randomized Evaluation. Am J Public Health. 2015 Jul;105(7):1344-50. doi: 10.2105/AJPH.2015.302594. Epub 2015 May 14.
- Background: PubMed 29902697White C, Shanley DC, Zimmer-Gembeck MJ, Walsh K, Hawkins R, Lines K, Webb H. Promoting young children's interpersonal safety knowledge, intentions, confidence, and protective behavior skills: Outcomes of a randomized controlled trial. Child Abuse Negl. 2018 Aug;82:144-155. doi: 10.1016/j.chiabu.2018.05.024. Epub 2018 Jun 11.
- BackgroundWurtele SK. Teaching young children personal body safety. The Body Safety Training Workbook. 2007. University of Colorado: Colorado Springs.
- BackgroundAkgül E, Darak S, Sisman FN, Ergun A. Effect of the Nurse-Led. Journal of Psychiatric Nursing. 2021; 12(2): 156-164.
- Background: PubMed 29856274Citak Tunc G, Gorak G, Ozyazicioglu N, Ak B, Isil O, Vural P. Preventing Child Sexual Abuse: Body Safety Training for Young Children in Turkey. J Child Sex Abus. 2018 May-Jun;27(4):347-364. doi: 10.1080/10538712.2018.1477001. Epub 2018 Jun 1.
- BackgroundIrmak TY, Kızıltepe R, Aksel Ş, Güngör D, Eslek D. Mika ile kendimi korumayı öğreniyorum: Cinsel istismarı önleme programının etkililiği ["I am learning to protect myself with Mika": The effectiveness of a sexual abuse prevention program]. Türk Psikoloji Dergisi. 2018; 33(81): 41-61.
- Background: PubMed 33549294Warraitch A, Amin R, Rashid A. Evaluation of a school-based sexual abuse prevention program for female children with intellectual disabilities in rural Pakistan- A feasibility study. Appl Nurs Res. 2021 Feb;57:151391. doi: 10.1016/j.apnr.2020.151391. Epub 2020 Nov 25.
- The California Evidence-Based Clearinghouse for Child Welfare. (CEBC). Prevention of Child Abuse and Neglect (Primary) ProgramsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Partner
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.
Ayse Ergun, Prof study chair
Marmara University
Esma Akgul, MSc, RN principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Led Body Protection Education and Reminder Education Brochure in people with Child Sexual Abuse and Disability, Vision, run by Marmara University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Good Touch subscale of the Children's Knowledge of Abuse Questionnaire-Revised scale (time frame: Change in knowledge level within two months). The study lists 2 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 NCT06497803, which also lists 18 linked publications.
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 24 Jul 2024.