NCT05529732

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2022

Completed
Last Updated

June 23, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

September 1, 2022

Last Update Submit

June 19, 2026

Conditions

Keywords

e-mobile educationthyroidectomyanxietyactivities of daily livingnursingLife Model

Outcome Measures

Primary Outcomes (1)

  • STAI State and Trait Anxiety Inventory

    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.

    Preoperative assessment and postoperative days 3, 7, and 10

Secondary Outcomes (1)

  • Assessment and Monitoring Form for Daily Living Activities

    Postoperative days 3, 7, and 10

Study Arms (2)

Application Group

EXPERIMENTAL

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.

Other: e-Mobile Application Patient Education for Patients with Thyroidectomy

Control Group

NO INTERVENTION

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.

Interventions

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.

Application Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Muaz GÜLŞEN

Adana, Adana, 01250, Turkey (Türkiye)

Location

Muaz Gülşen

Adana, Asia, 01250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Thyroidectomy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
After the researh report is written, a third person will assing an intervention and control group to the letters
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Prospective, 2-arm (1:1), simple randomized controlled interventional study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academic Lecturer

Study Record Dates

First Submitted

September 1, 2022

First Posted

September 7, 2022

Study Start

September 1, 2021

Primary Completion

March 1, 2022

Study Completion

November 21, 2022

Last Updated

June 23, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations