Skip to content

The Effect of Using Multimedia During the Informed Consent Process on the Anxiety of Parents of Orchiopexy Patients

The Effect of Using Multimedia During the Informed Consent Process on the Anxiety of Parents of Orchiopexy Patients: a Randomized Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06698081
Enrollment
70
Registered
2024-11-20
Start date
2024-11-20
Completion date
2025-03-28
Last updated
2024-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety State, Undescended Testis

Keywords

undescended testis, anxiety state

Brief summary

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

OTHERVideo 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.

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* parents of orchiopexy patients

Exclusion criteria

* history of previous orchiopexy surgery * orchiopexy with other surgical procedures ( f.e. Hypospadias repair)

Design outcomes

Primary

MeasureTime frameDescription
Hospital Anxiety and Depression Scale (HADS)1 weekThe participants' HADS scores will be noted one day before the surgery and on the 7th day after the surgery.
Beck Anxiety Inventory1 weekThe participants' BECK anxiety scores will be noted one day before the surgery and on the 7th day after the surgery.
State-Trait Anxiety Inventory (STAI)1 weekThe participants' STAI - Tx I and STAI -Tx II scores will be noted one day before and on the 7th day after the surgery.

Countries

Turkey (Türkiye)

Contacts

Primary ContactMehmet Çetin
m.cetin_47@hotmail.com+905366961923

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026