The Impact of e-Mobile Education Based on the Life Model on Anxiety and Daily Living Activities in Thyroidectomy Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 4
- 主要终点
- STAI State and Trait Anxiety Inventory:
研究概览
简要总结
This study aimed to assess the impact of e-mobile training, structured according to the Life Model, on the anxiety levels and daily living activities of patients who had undergone thyroidectomy.
The study was conducted as a prospective, two-arm (1:1), randomized controlled interventional study involving 68 patients. All patients received standard discharge protocols. In addition, patients in the intervention group received Life Model-based e-mobile education through a mobile application.
Trait anxiety was assessed before surgery, while state anxiety and activities of daily living were evaluated on postoperative days 3, 7, and 10. The study investigated whether e-mobile education could reduce anxiety levels and improve adaptation to daily living activities after thyroidectomy.
详细描述
The study was designed as a prospective, two-arm (1:1), randomized controlled interventional study.
The study officially commenced in September 2021 with the development of the e-mobile intervention. During the preparatory phase (September 2021-February 2022), educational content was developed according to the Life Model, expert evaluations were completed, the mobile application was developed with the support of software engineers and graphic designers, pilot testing was conducted, and sample size calculations were performed.
Participant recruitment and data collection were conducted in the general surgery clinic of a university hospital between March and November 2022.
The sample consisted of patients who underwent partial thyroidectomy due to benign thyroid disease, were between 18 and 65 years of age, were able to communicate, used Android-based smartphones, and agreed to participate in the study.
A pilot study was conducted before the main trial, and sample size was determined using a priori power analysis. A total of 68 participants were included in the study and randomized into intervention and control groups.
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
- Single (Outcomes Assessor)
盲法说明
After the researh report is written, a third person will assing an intervention and control group to the letters
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned thyroidectomy for benign thyroid disease
- •Hospitalized at least one day before surgery
- •Aged between 18 and 65 years
- •Able to communicate in Turkish
- •Conscious and oriented to person, place, and time
- •No psychiatric disorder
- •No hearing, speech, or visual impairment
- •Undergoing partial thyroidectomy, lobectomy, or total thyroidectomy under general anesthesia
- •Possession and use of an Android-based smartphone
- •Willing to participate and provide written informed consent
排除标准
- •Presence of psychiatric disorders
- •Hearing, speech, or visual impairment
- •Refusal to provide informed consent
- •Withdrawal from the study after enrollment
- •Failure to use the e-mobile application after allocation to the intervention group
- •Employment in a health-related profession
- •Cancellation of surgery for any reason
- •Inability to be contacted during the follow-up period
研究组 & 干预措施
Application Group
Participants in the intervention group received standard discharge protocols and Life Model-based e-mobile education. One day before surgery, the Personal Information Form and Trait Anxiety Scale were administered. The e-mobile application was installed on participants' Android smartphones and individual usernames and passwords were provided. Participants received approximately 15 minutes of one-to-one training on application use. The application included educational content related to preoperative, postoperative, and home-care periods, frequently asked questions, reminder notifications, questionnaires, and a messaging system. State Anxiety Scale and Activities of Daily Living Assessment and Monitoring Form were completed through the application on postoperative days 3, 7, and 10. Reminder notifications were sent through the application to support questionnaire completion.
干预措施: e-Mobile Application Patient Education for Patients with Thyroidectomy (Other)
Control Group
Participants in the control group received standard discharge protocols only during the study period. One day before surgery, the Personal Information Form and Trait Anxiety Scale were administered. On postoperative days 3, 7, and 10, the researcher contacted participants by telephone and administered the State Anxiety Scale and Activities of Daily Living Assessment and Monitoring Form. No e-mobile education was provided during the intervention period. After completion of the study, participants in the control group were provided access to the educational material.
结局指标
主要结局
STAI State and Trait Anxiety Inventory:
时间窗: 1 year
STAI State and Trait Anxiety Inventory: The scale was developed by Spielberger in 1964 and adapted into Turkish by Öner and Le Compte. The scale consists of two parts and includes a total of 40 questions. 20 questions in the first part evaluate the state anxiety of individuals, and 20 questions in the second part evaluate the trait anxiety.
次要结局
未报告次要终点
研究者
Muaz Gulsen
Academic Lecturer
Cukurova University