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Completed

NCT Number: NCT05529732

The Effect of Mobile Education on Anxiety and Activities of Daily Living

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Muaz GÜLŞEN, Adana, Turkey (Türkiye)

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About this study

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.

The intervention group received Life Model-based e-mobile education in addition to standard discharge protocols. The e-mobile application was developed by the researchers with the support of software engineers and graphic designers. Educational content was structured according to the Activities of Daily Living Model developed by Roper, Logan, and Tierney. The application included information related to the preoperative, postoperative, and home-care periods, educational materials, frequently asked questions, questionnaires, reminder functions, and a messaging system.

The control group received standard discharge protocols only during the study period. After completion of the study, participants in the control group were provided access to the educational material.

Data were collected using the Personal Information Form, State-Trait Anxiety Inventory (STAI), and Activities of Daily Living Assessment and Monitoring Form. Trait anxiety was assessed preoperatively. State anxiety and activities of daily living were assessed on postoperative days 3, 7, and 10.

The primary objective of the study was to evaluate the effect of e-mobile education on anxiety levels following thyroidectomy. The secondary objective was to evaluate its effect on activities of daily living during the postoperative recovery period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

e-Mobile Application Patient Education for Patients with Thyroidectomy

Other

Its mobile application is prepared according to the "Android Operating System" and can be downloaded free of charge from the Google Play Store, it is an application that provides training and consultancy services for patients who have had thyroidectomy surgery.

Primary outcomes

  1. STAI State and Trait Anxiety Inventory

    Time frame: Preoperative assessment and postoperative days 3, 7, and 10

    State and trait anxiety were assessed using the State-Trait Anxiety Inventory (STAI). Trait anxiety was assessed preoperatively, whereas state anxiety was assessed on postoperative days 3, 7, and 10. Higher scores indicate higher anxiety levels.

Secondary outcomes

  1. Assessment and Monitoring Form for Daily Living Activities

    Time frame: Postoperative days 3, 7, and 10

    Activities of daily living were assessed using the Assessment and Monitoring Form for Daily Living Activities. The form evaluates patients' adaptation to daily living activities during the postoperative recovery period. Higher scores indicate greater difficulty in performing daily living activities.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

The Impact of e-Mobile Education Based on the Life Model on Anxiety and Daily Living Activities in Thyroidectomy Patients: A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 7, 2022
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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