The Effect of Using Multimedia During the Informed Consent Process on the Anxiety of Parents of Orchiopexy Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Hospital Anxiety and Depression Scale (HADS)
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •parents of orchiopexy patients
排除标准
- •history of previous orchiopexy surgery
- •orchiopexy with other surgical procedures ( f.e. Hypospadias repair)
研究组 & 干预措施
Standard Informed Consent Form + Verbal Information
The first group will be informed of the Standard Informed Consent Form and Verbal Information during the preoperative process.
Standard Informed Consent Form + Verbal Information + Multimedia
The second group will be informed of the Standard Informed Consent Form, Verbal Information, and Multimedia.
干预措施: Video Multimedia (Other)
结局指标
主要结局
Hospital Anxiety and Depression Scale (HADS)
时间窗: 1 week
The participants' HADS scores will be noted one day before the surgery and on the 7th day after the surgery.
Beck Anxiety Inventory
时间窗: 1 week
The 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)
时间窗: 1 week
The participants' STAI - Tx I and STAI -Tx II scores will be noted one day before and on the 7th day after the surgery.
次要结局
未报告次要终点