Undescended TestisNCT06698081
The Effect of Using Multimedia During the Informed Consent Process on the Anxiety of Parents of Orchiopexy Patients
A study testing Video Multimedia in people with Undescended Testis and Anxiety State, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Aim: The goal of this randomized controlled trial is to detect the effect of using multimedia during the informed consent process on the anxiety of parents of orchiopexy patients. Parents (primary caregivers) of the patients who underwent orchiopexy surgery are included in the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Undescended Testis, Anxiety State
- What is being tested?
- Video Multimedia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2024to 28 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- parents of orchiopexy patients
Who cannot join
- history of previous orchiopexy surgery
- orchiopexy with other surgical procedures ( f.e. Hypospadias repair)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University School of Medicine, Department of Urology
Istanbul, Istanbul, 34890
Mehmet Çetin, +905366961923, m.cetin_47@hotmail.com
About this study
Official title: The Effect of Using Multimedia During the Informed Consent Process on the Anxiety of Parents of Orchiopexy Patients: a Randomized Controlled Trial
Aim: The goal of this randomized controlled trial is to detect the effect of using multimedia during the informed consent process on the anxiety of parents of orchiopexy patients.
Parents (primary caregivers) of the patients who underwent orchiopexy surgery are included in the study.
The main question it aims to answer is:
- Does the use of multimedia during the preoperative consent process affect the anxiety level of parents of patients undergoing orchiopexy surgery?
Read the detailed description
Aim: The goal of this randomized controlled trial is to detect the effect of using multimedia during the informed consent process on the anxiety of parents of orchiopexy patients.
Parents (primary caregivers) of the patients who underwent orchiopexy surgery are included in the study.
The patient's age, gender, known diseases, previous hospital admissions, and whether they have undergone surgery before will be recorded. The primary caregiver's age, gender, known diseases, educational status, occupation, number of children, and any additional illnesses in other children will be noted.
Patients will be randomized into 2 groups with the help of (https://www.randomizer.org/ ). The first group will be informed of the Standard Consent Form and Verbal Information during the preoperative process. In contrast, the second group will be informed of the Standard Consent Form, Verbal Information, and Multimedia. Both groups will fill out the Hospital Anxiety and Depression Scale(HADS), BECK Anxiety Inventory(BAI), and The State-Trait Anxiety Inventory (STAI) Form Tx 1-2 forms one day before the surgery and on the 7th day after the surgery to determine their anxiety levels.
- Conditions
- Undescended Testis, Anxiety State
- Being tested
- Video Multimedia
- Keywords
- undescended testis, anxiety state
- Medical subject headings
- Cryptorchidism, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video MultimediaOther
Also called Multimedia Group
The second group will be informed of the Standard Informed Consent Form, Verbal Information, and Multimedia. In addition to the standard consent process, we planned to show a 6-minute video multimedia presentation containing information about undescended testis and orchiopexy.
| Study group | Role | What they receive |
|---|---|---|
| Standard Informed Consent Form + Verbal Information | No intervention | The first group will be informed of the Standard Informed Consent Form and Verbal Information during the preoperative process. |
| Standard Informed Consent Form + Verbal Information + Multimedia | Active comparator | The second group will be informed of the Standard Informed Consent Form, Verbal Information, and Multimedia. Receives: Other: Video Multimedia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale (HADS)
The participants' HADS scores will be noted one day before the surgery and on the 7th day after the surgery.
Measured: 1 week
Beck Anxiety Inventory
The participants' BECK anxiety scores will be noted one day before the surgery and on the 7th day after the surgery.
Measured: 1 week
State-Trait Anxiety Inventory (STAI)
The participants' STAI - Tx I and STAI -Tx II scores will be noted one day before and on the 7th day after the surgery.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start20 Nov 2024 (estimated)
- Primary completion25 Mar 2025 (estimated)
- Study completion28 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Undescended TestisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cagri Akin Sekerci, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698081
- Sponsor's protocol ID
- MAR.UAD.009
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 20 Nov 2024
- 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 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Multimedia During the Informed Consent Process on the Anxiety of Parents of Orchiopexy Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06698081
- Acronym / sponsor ID
- MAR.UAD.009
- Conditions
- Undescended Testis, Anxiety State
- Keywords
- undescended testis, anxiety state
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 20 Nov 2024 (estimated)
- Primary completion
- 25 Mar 2025 (estimated)
- Study completion
- 28 Mar 2025 (estimated)
- First posted
- 20 Nov 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.
Aim: The goal of this randomized controlled trial is to detect the effect of using multimedia during the informed consent process on the anxiety of parents of orchiopexy patients.
Parents (primary caregivers) of the patients who underwent orchiopexy surgery are included in the study.
The main question it aims to answer is:
- Does the use of multimedia during the preoperative consent process affect the anxiety level of parents of patients undergoing orchiopexy surgery?
Detailed description
Aim: The goal of this randomized controlled trial is to detect the effect of using multimedia during the informed consent process on the anxiety of parents of orchiopexy patients.
Parents (primary caregivers) of the patients who underwent orchiopexy surgery are included in the study.
The patient's age, gender, known diseases, previous hospital admissions, and whether they have undergone surgery before will be recorded. The primary caregiver's age, gender, known diseases, educational status, occupation, number of children, and any additional illnesses in other children will be noted.
Patients will be randomized into 2 groups with the help of (https://www.randomizer.org/ ). The first group will be informed of the Standard Consent Form and Verbal Information during the preoperative process. In contrast, the second group will be informed of the Standard Consent Form, Verbal Information, and Multimedia. Both groups will fill out the Hospital Anxiety and Depression Scale(HADS), BECK Anxiety Inventory(BAI), and The State-Trait Anxiety Inventory (STAI) Form Tx 1-2 forms one day before the surgery and on the 7th day after the surgery to determine their anxiety levels.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Informed Consent Form + Verbal Information | No intervention | –The first group will be informed of the Standard Informed Consent Form and Verbal Information during the preoperative process. |
| Standard Informed Consent Form + Verbal Information + Multimedia | Active comparator | Other: Video MultimediaThe second group will be informed of the Standard Informed Consent Form, Verbal Information, and Multimedia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- parents of orchiopexy patients
Key exclusion criteria (2 listed)
- history of previous orchiopexy surgery
- orchiopexy with other surgical procedures ( f.e. Hypospadias repair)
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 |
|---|---|---|
| Video MultimediaAlso: Multimedia GroupThe second group will be informed of the Standard Informed Consent Form, Verbal Information, and Multimedia. In addition to the standard consent process, we planned to show a 6-minute video multimedia presentation containing information about undescended testis and orchiopexy. | Other | Standard Informed Consent Form + Verbal Information + Multimedia |
Primary outcome
Hospital Anxiety and Depression Scale (HADS)
Time frame: 1 week
The participants' HADS scores will be noted one day before the surgery and on the 7th day after the surgery.
Beck Anxiety Inventory
Time frame: 1 week
The participants' BECK anxiety scores will be noted one day before the surgery and on the 7th day after the surgery.
State-Trait Anxiety Inventory (STAI)
Time frame: 1 week
The participants' STAI - Tx I and STAI -Tx II scores will be noted one day before and on the 7th day after the surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Undescended Testis
Active, not recruitingObservational study
INVESTIGATION OF THE GENETIC ETIOLOGY OF HERNIA SAC DEVELOPMENT IN MALE CHILDREN WITH UNDESCENDED TESTIS AND INGUINAL HERNIA
Indirect Inguinal Hernia, Undescended Testis
Recruiting
Comparison of Single Incision Scrotal vs Standard Two Incision Inguinal Orchidopexy in Children Under 10 Years.
Undescended Testis
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.
Cagri Akin Sekerci study director
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 Video Multimedia in people with Undescended Testis and Anxiety State, 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 2 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: looking for participants now, as of the sponsor's last update on 20 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mehmet Çetin (+905366961923, m.cetin_47@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (HADS) (time frame: 1 week). The study lists 3 primary outcomes in all. 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 20 Nov 2024; AzTrials last refreshed its copy on 28 Oct 2026.