ThyroidectomyNCT05529732
The Effect of Mobile Education on Anxiety and Activities of Daily Living
A study testing e-Mobile Application Patient Education for Patients with Thyroidectomy in people with Thyroidectomy and Postoperative Anxiety, run by Cukurova University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thyroidectomy, Postoperative Anxiety, Benign Thyroid Disease
- What is being tested?
- e-Mobile Application Patient Education for Patients with Thyroidectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 21 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Muaz GÜLŞEN
Adana, Adana, 01250
Muaz Gülşen
Adana, Asia, 01250
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Thyroidectomy, Postoperative Anxiety, Benign Thyroid Disease
- Being tested
- e-Mobile Application Patient Education for Patients with Thyroidectomy
- Keywords
- e-mobile education, thyroidectomy, anxiety, activities of daily living, nursing, Life Model
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-Mobile Application Patient Education for Patients with ThyroidectomyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative assessment and postoperative days 3, 7, and 10
Secondary outcomes (1)
Assessment and Monitoring Form for Daily Living Activities
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.
Measured: Postoperative days 3, 7, and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Sep 2021
- Primary completion1 Mar 2022
- Study completion21 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidectomyStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, 2-arm (1:1), simple randomized controlled interventional study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muaz Gulsen, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529732
- Sponsor's protocol ID
- CukurovaUnıversıty
- Status last verified
- Jun 2026
- First submitted
- 1 Sep 2022
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05529732
- Acronym / sponsor ID
- CukurovaUnıversıty
- Conditions
- Thyroidectomy, Postoperative Anxiety, Benign Thyroid Disease
- Keywords
- e-mobile education, thyroidectomy, anxiety, activities of daily living, nursing, Life Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 21 Nov 2022 (actual)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, 2-arm (1:1), simple randomized controlled interventional study.
| Arm | Type | Receives |
|---|---|---|
| Application Group | Experimental | Other: e-Mobile Application Patient Education for Patients with ThyroidectomyParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-Mobile Application Patient Education for Patients with ThyroidectomyIts 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. | Other | Application Group |
Primary outcome
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.
1 secondary outcome
Assessment and Monitoring Form for Daily Living Activities
Time frame: Postoperative days 3, 7, and 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-Mobile Application Patient Education for Patients with Thyroidectomy in people with Thyroidectomy and Postoperative Anxiety, run by Cukurova University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
STAI State and Trait Anxiety Inventory (time frame: Preoperative assessment and postoperative days 3, 7, and 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.