An interventional study of Video Multimedia in Undescended Testis and Anxiety State, sponsored by Marmara University. Recruiting at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Marmara University · Not applicable, Interventional, and Supportive care
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:
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.
40 studies on the registry are indexed under Cryptorchidism; 14 are open to participants now.
This study's planned enrollment of 70 is close to the median of 70 across 26 interventional studies indexed under Cryptorchidism.
Browse Cryptorchidism studies →Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.
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Exclusion Criteria:
The first group will be informed of the Standard Informed Consent Form and Verbal Information during the preoperative process.
The second group will be informed of the Standard Informed Consent Form, Verbal Information, and Multimedia.
Other: Video Multimedia
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.
Also known as: Multimedia Group
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.
Time frame: 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.
Time frame: 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.
Time frame: 1 week
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2024; primary completion for Mar 2025, 4 months later.
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