The Effect of Using Multimedia During the Informed Consent Process on the Anxiety of Parents of Orchiopexy Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarmara University
About this 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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
parents of orchiopexy patients
Disqualifiers
history of previous orchiopexy surgery
orchiopexy with other surgical procedures ( f.e. Hypospadias repair)
Trial design
Design model
Parallel
Treatments tested in this trial
Video Multimedia
Other interventionThe 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Standard Informed Consent Form + Verbal InformationNo intervention 0 interventions
Group B: Standard Informed Consent Form + Verbal Information + MultimediaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 week2
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 week3
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 weekSponsors and contacts
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Source ClinicalTrials.gov