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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05729672
Other study ID # 106-2629-S-182-002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 31, 2017
Est. completion date October 31, 2020

Study information

Verified date February 2023
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a three-year research project. The goal is to develop and test "The SPOC-based blended teaching and learning platform (Nightingale in Gen-sEx)" that integrates effective educational strategies and e-learning methods to meet the Taiwanese nurse's learning needs. This project is aimed at resolving sexual education learning problems in nursing continuing education due to the time constraints at clinical sites and the shortage of teaching staff. Nurse-patient communication attitudes and skills about sex will be enhanced.


Description:

The research team constructed a course for hospital nurses that followed the commonly used ADDIE (Analysis, Design, Development, Implementation, and Evaluation) model. The first year research purpose is to: (1) explore the characteristics of nursing-patient communication about sex and the core educational needs content for nurses using triangulation methods. (2) Construct gender-sensitivity structures characteristics of nursing-patient communication about sex and course framework according to the modified Delphi method results and course needs assessment. The second year develops the SPOC-based blended teaching and learning platform (E-generation Angel of Happiness") and conducts a pilot study to test and correct the course content and method. In the third year a pretest-posttest randomized control group design will be implemented to investigate the effectiveness of the course "E-generation Angel of Happiness" in improving competencies of nurse-patient communication about sex, including attitudes, and practices, among nurses.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date October 31, 2020
Est. primary completion date August 16, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria: 1. 20 to 50 years old. 2. Below N3 rank. 3. Full-time nurse in clinical care. 4. Have smartphones or computers, and be able to use and be online. 5. Nurses who are willing to participate in this study and sign the consent form Exclusion Criteria: 1. Will leave within 3 months. 2. unable to learn online. 3. The working units are surgery room, recovery room, hospice ward, supply center.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Received the Nightingale in Gen-sEx course
The experimental group (n=75) will participate in the SPOC- based education program, consisting of five online teaching and learning modules over the span of 3 months and two hours of offline classroom.

Locations

Country Name City State
Taiwan Cheng Gung Memorial Hospital Taoyuan Guishan Dist.

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (27)

Aloush SM. Lecture-based education versus simulation in educating student nurses about central line-associated bloodstream infection-prevention guidelines. J Vasc Nurs. 2019 Jun;37(2):125-131. doi: 10.1016/j.jvn.2018.11.006. Epub 2019 Jan 7. — View Citation

Annerstedt CF, Glasdam S. Nurses' attitudes towards support for and communication about sexual health-A qualitative study from the perspectives of oncological nurses. J Clin Nurs. 2019 Oct;28(19-20):3556-3566. doi: 10.1111/jocn.14949. Epub 2019 Jun 4. — View Citation

Bardach, L., Rushby, J. V., Kim, L. E., & Klassen, R. M. (2021). Using video-and text-based situational judgement tests for teacher selection: a quasi-experiment exploring the relations between test format, subgroup differences, and applicant reactions. European Journal of Work and Organizational Psychology, 30(2), 251-264. doi: 10.1080/1359432X.2020.1736619

Button D, Harrington A, Belan I. E-learning & information communication technology (ICT) in nursing education: A review of the literature. Nurse Educ Today. 2014 Oct;34(10):1311-23. doi: 10.1016/j.nedt.2013.05.002. Epub 2013 Jun 18. — View Citation

Cant RP, Cooper SJ. Simulation-based learning in nurse education: systematic review. J Adv Nurs. 2010 Jan;66(1):3-15. doi: 10.1111/j.1365-2648.2009.05240.x. — View Citation

Delen, E., Liew, J., & Willson, V. (2014). Effects of interactivity and instructional scaffolding on learning: Self-regulation in online video-based environments. Computers & Education, 78, 312-320.

Faulder GS, Riley SC, Stone N, Glasier A. Teaching sex education improves medical students' confidence in dealing with sexual health issues. Contraception. 2004 Aug;70(2):135-9. doi: 10.1016/j.contraception.2004.03.010. — View Citation

Fennell R, Grant B. Discussing sexuality in health care: A systematic review. J Clin Nurs. 2019 Sep;28(17-18):3065-3076. doi: 10.1111/jocn.14900. Epub 2019 Jun 13. — View Citation

Frederick NN, Campbell K, Kenney LB, Moss K, Speckhart A, Bober SL. Barriers and facilitators to sexual and reproductive health communication between pediatric oncology clinicians and adolescent and young adult patients: The clinician perspective. Pediatr Blood Cancer. 2018 Aug;65(8):e27087. doi: 10.1002/pbc.27087. Epub 2018 Apr 26. — View Citation

Habes EV, Jepma P, Parlevliet JL, Bakker A, Buurman BM. Video-based tools to enhance nurses' geriatric knowledge: A development and pilot study. Nurse Educ Today. 2020 Apr 3;90:104425. doi: 10.1016/j.nedt.2020.104425. Online ahead of print. — View Citation

Huang CY, Tsai LY, Liao WC, Lee S. Nursing interventions on sexual health: validation of the NISH Scale in baccalaureate nursing students in Taiwan. J Sex Med. 2012 Oct;9(10):2600-8. doi: 10.1111/j.1743-6109.2012.02784.x. Epub 2012 May 22. — View Citation

Jonsdottir JI, Zoega S, Saevarsdottir T, Sverrisdottir A, Thorsdottir T, Einarsson GV, Gunnarsdottir S, Fridriksdottir N. Changes in attitudes, practices and barriers among oncology health care professionals regarding sexual health care: Outcomes from a 2-year educational intervention at a University Hospital. Eur J Oncol Nurs. 2016 Apr;21:24-30. doi: 10.1016/j.ejon.2015.12.004. Epub 2016 Jan 5. — View Citation

Kim JH, Shin JS. Effects of an online problem-based learning program on sexual health care competencies among oncology nurses: a pilot study. J Contin Educ Nurs. 2014 Sep;45(9):393-401. doi: 10.3928/00220124-20140826-02. — View Citation

McDonald EW, Boulton JL, Davis JL. E-learning and nursing assessment skills and knowledge - An integrative review. Nurse Educ Today. 2018 Jul;66:166-174. doi: 10.1016/j.nedt.2018.03.011. Epub 2018 Mar 21. — View Citation

Mohamadi-Bolbanabad S, Farnam F, Pakgohar M. The Effect of Virtual Education on Midwifery Students' Knowledge of Child Sexual Training. Iran J Nurs Midwifery Res. 2019 Sep-Oct;24(5):337-342. doi: 10.4103/ijnmr.IJNMR_96_18. — View Citation

Percat A, Elmerstig E. "We should be experts, but we're not": Sexual counselling at the antenatal care clinic. Sex Reprod Healthc. 2017 Dec;14:85-90. doi: 10.1016/j.srhc.2017.10.001. Epub 2017 Oct 12. — View Citation

Quinn C, Platania-Phung C, Bale C, Happell B, Hughes E. Understanding the current sexual health service provision for mental health consumers by nurses in mental health settings: Findings from a Survey in Australia and England. Int J Ment Health Nurs. 2018 Oct;27(5):1522-1534. doi: 10.1111/inm.12452. Epub 2018 Mar 25. — View Citation

Quinn GP, Bowman Curci M, Reich RR, Gwede CK, Meade CD; ENRICH/ECHO Working Group; Vadaparampil ST. Impact of a web-based reproductive health training program: ENRICH (Educating Nurses about Reproductive Issues in Cancer Healthcare). Psychooncology. 2019 May;28(5):1096-1101. doi: 10.1002/pon.5063. Epub 2019 Apr 5. — View Citation

Reese JB, Lepore SJ, Daly MB, Handorf E, Sorice KA, Porter LS, Tulsky JA, Beach MC. A brief intervention to enhance breast cancer clinicians' communication about sexual health: Feasibility, acceptability, and preliminary outcomes. Psychooncology. 2019 Apr;28(4):872-879. doi: 10.1002/pon.5036. Epub 2019 Mar 13. — View Citation

Ross MW, Leshabari S, Rosser BRS, Trent M, Mgopa L, Wadley J, Kohli N, Agardh A. Evaluation of an assessment instrument for a sexual health curriculum for nurses and midwifery students in Tanzania: The sexual health education for professionals scale (SHEPS). Appl Nurs Res. 2018 Apr;40:152-156. doi: 10.1016/j.apnr.2018.01.005. Epub 2018 Feb 1. — View Citation

Sung SC, Lin YC. Effectiveness of the sexual healthcare education in nursing students' knowledge, attitude, and self-efficacy on sexual healthcare. Nurse Educ Today. 2013 May;33(5):498-503. doi: 10.1016/j.nedt.2012.06.019. Epub 2012 Jul 10. — View Citation

Tsai YF. Nurses' facilitators and barriers for taking a sexual history in Taiwan. Appl Nurs Res. 2004 Nov;17(4):257-64. doi: 10.1016/j.apnr.2004.09.011. — View Citation

Vural, O. F. (2013). The Impact of a Question-Embedded Video-Based Learning Tool on E-Learning. Educational Sciences: Theory and Practice, 13(2), 1315-1323.

Wang LY, Pierdomenico A, Lefkowitz A, Brandt R. Female Sexual Health Training for Oncology Providers: New Applications. Sex Med. 2015 Sep;3(3):189-97. doi: 10.1002/sm2.66. Epub 2015 Apr 14. — View Citation

Webb L, Clough J, O'Reilly D, Wilmott D, Witham G. The utility and impact of information communication technology (ICT) for pre-registration nurse education: A narrative synthesis systematic review. Nurse Educ Today. 2017 Jan;48:160-171. doi: 10.1016/j.nedt.2016.10.007. Epub 2016 Oct 26. — View Citation

World Health Organization (2017). Sexual and Reproductive Health, Retrieved from http://www.who.int.proxy.lib.cgu.edu.tw:81/reproductivehealth/topics/sexual_health/sh_definitions/en/

Zhang, D., Zhou, L., Briggs, R. O., & Nunamaker Jr, J. F. (2006). Instructional video in e-learning: Assessing the impact of interactive video on learning effectiveness. Information & management, 43(1), 15-27. doi: 10.1016/j.im.2005.01.004

* Note: There are 27 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Sexual Communication between Nurses and Patients The research project assessed changes in sexual communication between Nurses and Patients by Sexual Communication Scale between Nurses and Patients(SCS-NS) from baseline to 3 months after the course.
Sexual Communication Scale between Nurses and Patients (SCS-NS) is developed with reference to "Questionnaires of barriers to discussing sexuality with patients" by Hordern et al. (2009). It has 14 items and consists of two parts: 1. Frequency of sexual communication with patients (4 items ) and 2. Sexual Communication Barrier Scale (10 questions). The Sexual Communication Obstacle Scale adopts a Likert 5-point scale for scoring, and the higher the score, the higher the sexual barrier to talking with the patient and the lower the level of nurse-patient communication. The questionnaire will undergo expert validity testing again, and the internal consistency of the scale reliability will be evaluated by the Cronbach Alpha coefficient.
Data were collected at baseline.
Primary Sexual Communication between Nurses and Patients The research project assessed changes in sexual communication between Nurses and Patients by Sexual Communication Scale between Nurses and Patients(SCS-NS) from baseline to 3 months after the course.
Sexual Communication Scale between Nurses and Patients (SCS-NS) is developed with reference to "Questionnaires of barriers to discussing sexuality with patients" by Hordern et al. (2009). It has 14 items and consists of two parts: 1. Frequency of sexual communication with patients (4 items ) and 2. Sexual Communication Barrier Scale (10 questions). The Sexual Communication Obstacle Scale adopts a Likert 5-point scale for scoring, and the higher the score, the higher the sexual barrier to talking with the patient and the lower the level of nurse-patient communication. The questionnaire will undergo expert validity testing again, and the internal consistency of the scale reliability will be evaluated by the Cronbach Alpha coefficient.
Data were collected at 1 month after the course.
Primary Sexual Communication between Nurses and Patients The research project assessed changes in sexual communication between Nurses and Patients by Sexual Communication Scale between Nurses and Patients(SCS-NS) from baseline to 3 months after the course.
Sexual Communication Scale between Nurses and Patients (SCS-NS) is developed with reference to "Questionnaires of barriers to discussing sexuality with patients" by Hordern et al. (2009). It has 14 items and consists of two parts: 1. Frequency of sexual communication with patients (4 items ) and 2. Sexual Communication Barrier Scale (10 questions). The Sexual Communication Obstacle Scale adopts a Likert 5-point scale for scoring, and the higher the score, the higher the sexual barrier to talking with the patient and the lower the level of nurse-patient communication. The questionnaire will undergo expert validity testing again, and the internal consistency of the scale reliability will be evaluated by the Cronbach Alpha coefficient.
Data were collected at 3 month after the course.
Primary Gender sensitivity The research project assessed changes in gender sensitivity by Gender-Sensitivity Scale for Nurses from baseline to 3 months after the course.
The scale" Gender-Sensitivity Scale for Nurses" is a self-development scale, referring to the gender-blind connotation of sexual health guidance for medical staff proposed by Lee et al. (2017) and the Gender Awareness Scale developed by Verdonk et al. (Njmegen Medical Gender Awareness Scale). (2007), to be developed. The scale consists of 14 items, with a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Questions 10, 12, 13, and 14 are reverse-scoring, and the scoring range is 10-50 points. The higher the score, the lower the gender sensitivity and gender blindness. The questionnaire will undergo the expert validity test, and Cronbach's a coefficient will evaluate the internal consistency of the scale reliability. In this study, Cronbach's alpha for the quantitative learning needs assessment was 0.79.
Data were collected at baseline.
Primary Gender sensitivity The research project assessed changes in gender sensitivity by Gender-Sensitivity Scale for Nurses from baseline to 3 months after the course.
The scale" Gender-Sensitivity Scale for Nurses" is a self-development scale, referring to the gender-blind connotation of sexual health guidance for medical staff proposed by Lee et al. (2017) and the Gender Awareness Scale developed by Verdonk et al. (Njmegen Medical Gender Awareness Scale). (2007), to be developed. The scale consists of 14 items, with a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Questions 10, 12, 13, and 14 are reverse-scoring, and the scoring range is 10-50 points. The higher the score, the lower the gender sensitivity and gender blindness. The questionnaire will undergo the expert validity test, and Cronbach's a coefficient will evaluate the internal consistency of the scale reliability. In this study, Cronbach's alpha for the quantitative learning needs assessment was 0.79.
Data were collected at 1 month after the course.
Primary Gender sensitivity The research project assessed changes in gender sensitivity by Gender-Sensitivity Scale for Nurses from baseline to 3 months after the course.
The scale" Gender-Sensitivity Scale for Nurses" is a self-development scale, referring to the gender-blind connotation of sexual health guidance for medical staff proposed by Lee et al. (2017) and the Gender Awareness Scale developed by Verdonk et al. (Njmegen Medical Gender Awareness Scale). (2007), to be developed. The scale consists of 14 items, with a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Questions 10, 12, 13, and 14 are reverse-scoring, and the scoring range is 10-50 points. The higher the score, the lower the gender sensitivity and gender blindness. The questionnaire will undergo the expert validity test, and Cronbach's a coefficient will evaluate the internal consistency of the scale reliability. In this study, Cronbach's alpha for the quantitative learning needs assessment was 0.79.
Data were collected at 3 month after the course.
Secondary Sexual health care attitudes The research project assessed changes in sexual health care attitude by the Sexual Health Care Scale-Attitude (SHCS-A) from baseline to 3 months after the course.
The Sexual Health Care Scale-Attitude (SHCS-A) was used to measure attitudes toward Sexual Health Care for oncology patients. This scale was developed for oncology nurses, and has been proven valid and reliable (Kim & Kim, 2011). The scale consists of 17 items, with each item rated on a three-point scale ranging from 1 (agree) to 3 (disagree). The total scores range from 17 to 51. The SHCS-A consists of four factors: discomfort in providing SHC, feeling uncertain about patient's acceptance, fear of colleagues' negative response, and lack of environmental support. Higher scores indicate a more positive attitude toward SHC for oncology patients. Cronbach's a for this scale was .93 (Kim & Kim, 2011).
Data were collected at baseline, 1 month, and 3 months after the course.
Secondary Readiness of talking about sex The research project assessed changes in readiness of talking about sex by Lee's (2019) "Readiness to Talk About Sex Stage Scale" from baseline to 3 months after the course.
Lee's (2019) "Readiness to Talk About Sex Stage Scale" assesses nurses' readiness to talk about sex with patients: "I do not think it is necessary to talk to patients about sex or provide sexual health information"; "I do not want to talk about sex with patients, nor have I talking to patients about sex"; "I think I should give sexual health advice to patients or talk to patients about sex, but I do not want to do so yet"; "I want to talk to patients about sex or provide sexual health counseling, however, I still not started"; "I have started talking to patients about sex or giving sexual health counseling"; "I have started talking to patients' about sex or giving sexual health counseling and have done so routinely for more than three months'"; and according to These five options are scored on a scale of 1 to 5.
Data were collected at baseline, 1 month, and 3 months after the course.
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