Enhancing Men's Awareness of Testicular Diseases (E-MAT): A Feasibility Trial

NCT05146466 | Completed

• 2 other identifiers: 21125DIFA-2020-028
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: Is it feasible to conduct a definitive trial to test the effect of E-MATVR compared to E-MATE on primary and secondary outcomes among Gaelic Athletic Association (GAA) members (players and coaches)? The overall aim of this study is to examine the feasibility of conducting a definitive trial to test the effect of an educational intervention to Enhance Men's Awareness of Testicular diseases using Virtual Reality (E-MATVR) among male GAA members. The effect of E-MATVR will be compared to E-MATE (control) which involves using the same information as E-MATVR delivered as plain text (e.g., PDF) with still images from E-MATVR.

Conditions

Testicular Diseases

Keywords

Testicular Diseases; Technology; Athletes; Knowledge; Social Media; Virtual Reality

Outcome Measures

Primary Outcomes (2)

• Testicular Knowledge Questionnaire

  Change in participants' knowledge of the normal testes, testicular symptoms, testicular self-examination, and testicular diseases as assessed by the Testicular Knowledge Questionnaire comprising 8 multiple choice questions and 4 'True' and 'False' type questions. All 12 items are dichotomised into "Correct=1" and "Incorrect/Don't know=0." Scores range between 0 and 12. Higher scores indicate greater knowledge.

  T0 (baseline), T1 (immediately post-test), T2 (three months post-test)

• Testicular Self-Examination Behaviour Questionnaire

  Change in participants' behaviours in relation to feeling their own testes and advising at least one man to do the same as assessed by the Testicular Self-Examination Behaviour Questionnaire comprising 3 'Yes' and 'No' type questions. All items are dichotomous: "Yes=1" and "No=0."

  T0 (baseline), T2 (three months post-test)

Secondary Outcomes (4)

• Testicular Awareness Scale

  T0 (baseline), T1 (immediately post-test), T2 (three months post-test)

• Implementations Intentions Scale

  T0 (baseline), T1 (immediately post-test), T2 (three months post-test)

• Perceived Risk Item

  T0 (baseline), T1 (immediately post-test), T2 (three months post-test)

• General Help-Seeking Questionnaire

  T0 (baseline), T1 (immediately post-test), T2 (three months post-test)

Study Arms (2)

E-MATVR (intervention)

OTHER

Behavioral: E-MATVR

E-MATEE (control)

OTHER

Behavioral: E-MATE

Interventions

E-MATVR BEHAVIORAL

It involves using computer software uploaded onto wireless virtual reality (VR) technology (similar to downloading an app on a mobile phone) and will be delivered using a headset, handheld controllers, and voiceover (all wireless). E-MATVR comprises three serious gaming levels aimed at familiarising men with the normal look and feel of the testes, common testicular symptoms and diseases, and the importance of early help-seeking.

E-MATVR (intervention)

E-MATE BEHAVIORAL

It involves using the same information as EMATVR delivered as plain text (e.g., PDF) with still images from E-MATVR. Participants will be given approximately 10 minutes to read the text/look at images using a tablet (e.g., iPad).

E-MATEE (control)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: The current project involves awareness of male-specific diseases (i.e. testicular diseases). Therefore, cis (biological) males, transwomen (male to female), and non-binary/gender nonconforming/gender neutral individuals who are biologically male will be eligible for inclusion. Individuals who are not biologically male will be welcome to interact with E-MATVR/E-MATE if desired; however, their participation will not be recorded.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Biological males.
• Members of the target GAA clubs (GAA players and coaches) since testicular injuries are common in field sports like hurling.
• Residing in Ireland.
• Aged 18-50 years (age group at risk for testicular diseases).

You may not qualify if:

• History of seizures.
• History of motion sickness.

Sponsors & Collaborators

• University College Cork: lead
• Health Research Board, Ireland: collaborator
• Health Research Board - Trials Methodology Research Network: collaborator

Study Sites (1)

Up to 12 geographically dispersed GAA clubs in Cork and neighbouring counties

Cork, Munster, Ireland

Location

Related Publications (3)

• Viechtbauer W, Smits L, Kotz D, Bude L, Spigt M, Serroyen J, Crutzen R. A simple formula for the calculation of sample size in pilot studies. J Clin Epidemiol. 2015 Nov;68(11):1375-9. doi: 10.1016/j.jclinepi.2015.04.014. Epub 2015 Jun 6.

  PMID: 26146089 BACKGROUND

• Murphy A, Kirby A, De Blasio F, McCarthy M, Shiely F, Hegarty J, Davoren MP, Harrington JM, Shorter GW, Murphy D, O'Mahony B, Cooke E, Rovito MJ, Robertson S, FitzGerald S, Connor AO, Riordan MO, Saab MM. Cost-Benefit Analysis of the Enhancing Men's Awareness of Testicular diseases (E-MAT) Feasibility Trial: A Virtual Reality Experience to Increase Testicular Knowledge and Self-Examination among Male Athletes. Pharmacoecon Open. 2025 Jul;9(4):671-682. doi: 10.1007/s41669-025-00571-5. Epub 2025 Mar 19.

  PMID: 40108097 DERIVED

• Saab MM, McCarthy M, Davoren MP, Shiely F, Harrington JM, Shorter GW, Murphy D, O'Mahony B, Cooke E, Murphy A, Kirby A, Rovito MJ, Robertson S, FitzGerald S, O'Connor A, O'Riordan M, Hegarty J, Dahly D. Enhancing Men's Awareness of Testicular Diseases (E-MAT) using virtual reality: A randomised pilot feasibility study and mixed method process evaluation. PLoS One. 2024 Jul 22;19(7):e0307426. doi: 10.1371/journal.pone.0307426. eCollection 2024.

  PMID: 39037976 DERIVED

Related Links

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MeSH Terms

Conditions

Testicular Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Mohamad M Saab, PhD, MSc, PGDTLHE, RGN

  University College Cork

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Given the differences between the two arms, participants will be aware of the arm they have been randomised into. Outcome assessments will be self-reported and returned to research staff with no information on allocation. Blinding will be maintained throughout data analysis. Unblinding will be facilitated by the independent statistician following completion of the protocol-specified data analysis.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Data will be collected in up to 12 Gaelic Athletic Association (GAA) sports clubs. For each of the participating GAA clubs, individual participants will be randomised with the same probability to one of the two arms (E-MATVR \[intervention\]/E-MATE \[control\]). Allocation concealment will be maintained using a computerised system. Once participants have consented and their baseline assessment has been entered into the computer database, their allocation will be given by automated email. Randomisation and allocation concealment will be conducted according to the standard operating procedures (SOPs) of the Statistics and Data Analysis Unit of the HRB Clinical Research Facility-Cork (HRB CRF-C).

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: December 6, 2021
• Study Start: March 15, 2022
• Primary Completion: November 22, 2022
• Study Completion: November 22, 2022
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)