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

Primary Purpose

Postoperative Anxiety, Mobile Education, Patient Education

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
e-Mobile Application Patient Education for Patients with Thyroidectomy
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postoperative Anxiety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Muaz GülşenRecruiting
  • Muaz GÜLŞEN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Application Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 1, 2022
Last Updated
October 2, 2023
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT05529732
Brief Title
The Effect of Mobile Education on Anxiety and Activities of Daily Living
Official Title
The Effect of e-Mobile Education Organized According to Life Model on Anxiety and Daily Living Activities of Patients With Thyroidectomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
October 3, 2023 (Actual)
Study Completion Date
October 3, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
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 "E-Mobile Application Training Content Guide" to be integrated into the mobile application will be evaluated by the experts with the "Conformity Evaluation Form of Written Training Materials" and the "DISCERN Scale". After the training content is completed, "Personal Information Form", "STAI State and Trait Anxiety Scale", "Assessment and Monitoring Form for Daily Living Activities" will be used. In the preliminary application, the "System Usability Scale" and the e-mobile application will be evaluated by the patients. The "E-Mobile Application Training Content Guide" created by the researchers in line with the literature will be transferred to the mobile application with the help of computer engineers and graphic designers. Sequence and visuality of education Roper et al. It was designed according to the Life Activities Based Nursing Model developed by The e-mobile application is designed in accordance with the Android operating system and its language is Turkish. Patients who download the application from the virtual market (Google Play) can log in with the user name and password created by the researcher. The user name and password were created by the researcher specifically for each patient during the research process. The number of clicks and the reading time of the topics read by the patients entering the application can be tracked with the help of the created web page. The research will be carried out with 2 groups as application (mobile application) and control (standard care).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Anxiety, Mobile Education, Patient Education, Anxiety, Activities of Daily Living

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, parallel, two-arm randomized controlled clinical trail
Masking
Outcomes Assessor
Masking Description
After the researh report is written, a third person will assing an intervention and control group to the letters
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Application Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
e-Mobile Application Patient Education for Patients with Thyroidectomy
Intervention Description
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 Outcome Measure Information:
Title
STAI State and Trait Anxiety Inventory:
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muaz GÜLŞEN, Master
Phone
03223386841
Email
muaz.gulsen@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sevban ARSLAN, PHD
Phone
03223386842
Email
sevbanadana@gmail.com
Facility Information:
Facility Name
Muaz Gülşen
City
Adana
State/Province
Asia
ZIP/Postal Code
01250
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
muaz GÜLŞEN, MSc
Phone
05316680452
First Name & Middle Initial & Last Name & Degree
Sevban ARSLAN, PhD
Phone
05368821645
Email
sevbanadana@gmail.com
Facility Name
Muaz GÜLŞEN
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Individual Site Status
Completed

12. IPD Sharing Statement

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

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