The Effect of Using Multimedia During the Informed Consent Process on the Anxiety of Parents of Orchiopexy Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Video Multimedia.
- Who it may be relevant to
- Registry conditions: Undescended Testis, Anxiety State. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Using Multimedia During the Informed Consent Process on the Anxiety of Parents of Orchiopexy Patients: a Randomized Controlled Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- Hospital Anxiety and Depression Scale (HADS) [Time frame: 1 week]
- Beck Anxiety Inventory [Time frame: 1 week]
- State-Trait Anxiety Inventory (STAI) [Time frame: 1 week]
Eligibility criteria
Inclusion criteria
- parents of orchiopexy patients
Exclusion criteria
- history of previous orchiopexy surgery
- orchiopexy with other surgical procedures ( f.e. Hypospadias repair)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Turkey (Türkiye) · 1 center
- Marmara University School of Medicine, Department of Urology — Istanbul
Identifiers
NCT: NCT06698081 · MAR.UAD.009