Testicular NeoplasmNCT06044220
Testicular Self-examination Training Given to Students
A study testing Intervention in people with Testicular Neoplasm, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Testicular Neoplasm
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Dec 2021to 5 Apr 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being a continuous student at Vocational School of Health Services,
- Being over 18 years of age,
- Volunteering.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of Testicular Self-examination Training Given to Male University Students
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.
Read more
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.
Read the 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).
- Conditions
- Testicular Neoplasm
- Being tested
- Intervention, Control
- Keywords
- Testicular Cancer, Testicular self-exam, Planned behavior theory scale
- Medical subject headings
- Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
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.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group is given a 3-month reminder after the TSE training. Receives: Behavioral: Intervention |
| control | Other | No training or reminders are given to the control group Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one week
Secondary outcomes (1)
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.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start21 Dec 2021
- Primary completion23 Dec 2021
- Study completion5 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular NeoplasmStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- intervention and control group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Öznur KIRMIZI AY, Karabuk University
- Investigators
- Gülcan KAR ŞEN, Study director, Assist. Prof. Dr., Department of Nursing Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044220
- Sponsor's protocol ID
- OKIRMIZIAY-001
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2023
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Testicular Self-examination Training Given to Male University Students
- ClinicalTrials.gov ID
- NCT06044220
- Acronym / sponsor ID
- OKIRMIZIAY-001
- Conditions
- Testicular Neoplasm
- Keywords
- Testicular Cancer, Testicular self-exam, Planned behavior theory scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 21 Sep 2023 (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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- intervention and control group
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionThe intervention group is given a 3-month reminder after the TSE training. |
| control | Other | Other: ControlNo training or reminders are given to the control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being a continuous student at Vocational School of Health Services,
- Being over 18 years of age,
- Volunteering.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| InterventionThe 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. | Behavioural | Intervention |
| ControlPretest 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. | Other | control |
Primary outcome
survey form and Theory of Planned Behavior scale for testicular self-examination
Time frame: one week
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.
1 secondary outcome
Planned behavior theory scale related to testicular self-examination
Time frame: one week
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 25 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Gülcan KAR ŞEN study director
Assist. Prof. Dr., Department of Nursing Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Testicular Neoplasm, run by Karabuk 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 3 inclusion and 3 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 25 Sep 2023. 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?
survey form and Theory of Planned Behavior scale for testicular self-examination (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2023.