Actively Recruiting
The Effect of Using Multimedia During the Informed Consent Process on the Anxiety of Parents of Orchiopexy Patients: a Randomized Controlled Trial
Led by Marmara University · Updated on 2024-11-20
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate how using multimedia during the informed consent process affects the anxiety levels of parents whose children undergo orchiopexy surgery, a procedure for undescended testis. The study is a randomized controlled trial focusing on parents as primary caregivers to understand if adding multimedia can change their anxiety compared to standard consent methods. Participants will be divided into two groups randomly. One group will receive the standard informed consent form and verbal information before surgery, while the other group will receive the same standard information plus a 6-minute video multimedia presentation about undescended testis and orchiopexy. Both groups will be assessed for anxiety before surgery and one week after surgery. Parents will complete three anxiety assessment forms: the Hospital Anxiety and Depression Scale (HADS), Beck Anxiety Inventory (BAI), and State-Trait Anxiety Inventory (STAI) one day before surgery and again seven days post-surgery. Researchers will collect background information on both patients and caregivers, including age, gender, medical history, and other relevant details. The study will monitor anxiety changes to understand the impact of multimedia on the consent process.
CONDITIONS
Brief Title
The Effect of Using Multimedia During the Informed Consent Process on the Anxiety of Parents of Orchiopexy Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parents of orchiopexy patients
You will not qualify if you...
- History of previous orchiopexy surgery
- Orchiopexy combined with other surgical procedures (e.g., hypospadias repair)
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 1 day before surgery
Participants receive the informed consent process either with standard verbal information and consent form or with additional multimedia support before the surgery.
1 preoperative visit (in-person)
Duration - 7 days after surgery
Participants complete anxiety assessment questionnaires on the 7th day after surgery to evaluate anxiety levels.
1 follow-up visit (in-person or remote)
Trial Site Locations
Total: 1 location
1
Marmara University School of Medicine, Department of Urology
Istanbul, Istanbul, Turkey (Türkiye), 34890
Actively Recruiting
Research Team
M
Mehmet Çetin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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