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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video Multimedia | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mehmet Çetin | Contact | +905366961923 | m.cetin_47@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Cagri Akin Sekerci | Marmara University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marmara University School of Medicine, Department of Urology | Recruiting | Istanbul | Istanbul | 34890 | Turkey (TĂ¼rkiye) |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 19, 2025 | |
| Reset | Mar 10, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 19, 2025 | Mar 10, 2025 |
| ID | Term |
|---|---|
| D003456 | Cryptorchidism |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D013733 | Testicular Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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|
|
| D052801 |
| Male Urogenital Diseases |
| D014564 | Urogenital Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D001523 | Mental Disorders |