Testicular Self-examination Training Given to Students
Primary Purpose
Testicular Neoplasm
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Intervention
Control
Sponsored by
About this trial
This is an interventional prevention trial for Testicular Neoplasm focused on measuring Testicular Cancer, Testicular self-exam, Planned behavior theory scale
Eligibility Criteria
Inclusion Criteria: Being a continuous student at Vocational School of Health Services, Being over 18 years of age, Volunteering. Exclusion Criteria: Those with a history of TC, Those with a family history of TC and Those with a history of testicular surgery such as undescended testicles, varicocelectomy and hydrocelectomy.
Sites / Locations
- Karabuk University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention
control
Arm Description
The intervention group is given a 3-month reminder after the TSE training.
No training or reminders are given to the control group
Outcomes
Primary Outcome Measures
survey form and Theory of Planned Behavior scale for testicular self-examination
A survey form consisting of 21 questions, prepared by the researcher by reviewing the literature, and the Theory of Planned Behavior scale adapted to Turkish on Testicular Self-Examination were applied as a pretest.
Secondary Outcome Measures
Planned behavior theory scale related to testicular self-examination
The Theory of Planned Behavior Scale on Testicular Self-Examination was applied as a posttest.
The minimum score to be obtained from the scale is 16 and the maximum is 112. Each dimension of the scale is evaluated separately, and as the score increases, positive behavior increases.
Full Information
NCT ID
NCT06044220
First Posted
September 12, 2023
Last Updated
September 21, 2023
Sponsor
Karabuk University
1. Study Identification
Unique Protocol Identification Number
NCT06044220
Brief Title
Testicular Self-examination Training Given to Students
Official Title
Evaluation of the Effectiveness of Testicular Self-examination Training Given to Male University Students
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 21, 2021 (Actual)
Primary Completion Date
December 23, 2021 (Actual)
Study Completion Date
April 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karabuk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this quasi-experimental control group study was to evaluate the effectiveness of testicular self-examination training given to male university students.
Hypotheses; H1a: Immediately after the training and three months after the training, the experimental and control groups' Planned Behavior Theory scale intention sub-dimension scores related to Testicular Self-Examination will increase.
H1b: Immediately after the training and three months after the training, the experimental and control groups' Planned Behavior Theory scale attitude sub-dimension scores related to Testicular Self-Examination will increase.
H1c: Immediately after the training and three months after the training, the experimental and control groups' Planned Behavior Theory scale subjective norm sub-dimension scores on Testicular Self-Examination will increase.
H1d: Immediately after the training and three months after the training, the experimental and control groups' Planned Behavior Theory scale perceived behavioral control sub-dimension scores will increase.
H1e: Immediately after the training and three months after the training, the scores of the Planned Behavior Theory scale self-efficacy sub-dimension related to Testicular Self-Examination will increase in the experimental and control groups.
H1f: Immediately after the training and three months after the training, the experimental and control group's Planned Behavior Theory scale total scores on Testicular Self-Examination will increase.
A questionnaire will be administered to the participants before and after the training of male health promotion and testicular self-examination, and the retest will be filled after the reminders about the smallpox given for 3 months.
The researcher will compare the intervention and control group to see if the behavior of performing testicular self-examination regularly occurs.
Detailed Description
The data of the research were obtained from the students of Medical Documentation and Secretarial Program, Medical Promotion and Marketing Program and Optician Program affiliated to Bartın University Vocational School of Health Services Medical Services and Techniques Department between 27 December - 5 April 2022. The research was carried out in 3 stages.
pre-enterprise phase; Data collection forms were applied to n=102 participants who met the inclusion criteria and accepted the study (pretest). One participant with varicocele and one participant with a history of undescended testicles were excluded from the study. Experiment (n=51) and control (n=49) groups were formed by drawing lots between the primary and secondary education programs.
Initiative stage; The "Male Health Promotion Training Program for Self-Testicular Examination" prepared by the researcher as a result of literature review (Power, et al. 2021; Taylor, 2004), was carried out in two sessions on different days in the same week. In the first session (30 minutes), the Anatomy of Male Reproductive Organs, Testicular Cancer and Risky Situations Caused by Testicular Cancer, in the second session (30 minutes) Testicular Self-Examination, the Importance of Regular Testicular Examination, and Fields of Expertise in Suspicion of Testicular Cancer were discussed. Data collection forms were applied for the second time immediately after the intervention (posttest). After the intervention, once a month for 3 months, the participants in the experimental group were reminded via mobile phone with the question "Have you done your Testicular Self Examination this month?".
Post-intervention stage; At the end of the third month after the intervention, the data collection forms were applied again and the research process was completed (Follow-up).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Testicular Neoplasm
Keywords
Testicular Cancer, Testicular self-exam, Planned behavior theory scale
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
intervention and control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention group is given a 3-month reminder after the TSE training.
Arm Title
control
Arm Type
Other
Arm Description
No training or reminders are given to the control group
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
The intervention group was given training on male reproductive health and testicular self-examination after the pretest. Posttest was administered after the training. He was reminded to perform TSE for 3 months after the training. After the reminders, a follow-up test was applied.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Pretest and posttest were administered to the control group at the same time as the intervention group. After reminding the intervention group to perform TSI for 3 months, a follow-up test was performed in the control group.
Primary Outcome Measure Information:
Title
survey form and Theory of Planned Behavior scale for testicular self-examination
Description
A survey form consisting of 21 questions, prepared by the researcher by reviewing the literature, and the Theory of Planned Behavior scale adapted to Turkish on Testicular Self-Examination were applied as a pretest.
Time Frame
one week
Secondary Outcome Measure Information:
Title
Planned behavior theory scale related to testicular self-examination
Description
The Theory of Planned Behavior Scale on Testicular Self-Examination was applied as a posttest.
The minimum score to be obtained from the scale is 16 and the maximum is 112. Each dimension of the scale is evaluated separately, and as the score increases, positive behavior increases.
Time Frame
one week
Other Pre-specified Outcome Measures:
Title
Theory of Planned Behavior scale for testicular self-examination
Description
The Theory of Planned Behavior Scale on Testicular Self-Examination was applied as a follow-up test.
Time Frame
three months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Being a continuous student at Vocational School of Health Services,
Being over 18 years of age,
Volunteering.
Exclusion Criteria:
Those with a history of TC,
Those with a family history of TC and
Those with a history of testicular surgery such as undescended testicles, varicocelectomy and hydrocelectomy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülcan KAR ŞEN
Organizational Affiliation
Assist. Prof. Dr., Department of Nursing Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Karabuk University
City
Karabük
ZIP/Postal Code
78050
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Testicular Self-examination Training Given to Students
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