NCT05529732

Brief Summary

The study was planned as a block randomized controlled experimental study. In order to calculate the sample size needed in our study, a pilot study will be conducted and a priori power analysis will be made based on the results of this study. E-mobile application will be used as data collection tool. The research will be carried out with 2 groups as application (mobile application) and control (standard care).

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

Click on a node to explore related trials.

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

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

September 1, 2022

Last Update Submit

November 22, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • STAI State and Trait Anxiety Inventory:

    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.

    1 year

Study Arms (2)

Application Group

EXPERIMENTAL

Oral and written consent will be obtained from the patients by face-to-face interview technique at least one day before the surgery. Then, face-to-face interview technique and data collection tools (Personal Information Form and Trait Anxiety Scale) will be applied. It is estimated that the process of obtaining consent and filling out the form will take approximately 5 minutes. The mobile application will be installed on the mobile devices of the patients and the user name and password will be defined by the researcher so that they can log into the mobile application. In the application, a patient warning notification will be sent on the 3rd, 7th and 10th days to remind the patients to fill in the State Anxiety Scale and Daily Living Activities Evaluation and Follow-up Form, which are included in the questionnaires menu and will be active when the day comes.

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

Control Group

NO INTERVENTION

Written consent will be obtained from the patients through a face-to-face interview at least one day before the surgery and the data collection form (Personal Information Form and Trait Anxiety Scale) will be filled. During this period, standard care and follow-up protocols will be applied to the patients by the clinic. Patients in the control group will be called by phone on the 3rd, 7th and 10th days of discharge. State Anxiety Scale and Daily Living Activities Evaluation and Follow-up Form will be applied by the researcher. The process is estimated to take 15 minutes.

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:

  • Thyroidectomy was planned for benign thyroid disease,
  • Hospitalized at least one day before the operation,
  • Voluntarily accepted to participate in the study,
  • Aged 18 and over,
  • Conscious, person-space-time orientation,
  • No psychiatric problems,
  • No hearing-speech and visual impairment
  • who can speak Turkish,
  • who underwent partial thyroidectomy/lobectomy/total thyroidectomy under general anesthesia and by the same surgeon,
  • who have been using a smartphone for at least one year will be included.

You may not qualify if:

  • Patients with psychiatric problems,
  • hearing or speech impairment, who did not approve the informed consent form, who gave up after approval,
  • who did not use the mobile application despite using a smartphone,
  • who have a profession in the field of health will not be included in the study.
  • In addition, patients who did not log into the mobile application, could not be contacted during the research process and whose surgery was canceled for any reason will not be included in the sample.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Muaz Gülşen

Adana, Asia, 01250, Turkey (Türkiye)

Location

Muaz GÜLŞEN

Adana, 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
OTHER
Intervention Model
PARALLEL
Model Details: Prospective, parallel, two-arm randomized controlled clinical trail
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

November 24, 2023

Record last verified: 2023-11

Locations