The Effect of Mobile Application-Based Education Given to Patients With Tracheostomy on Depression, Social Adaptation and Quality of Recovery

March 5, 2026 updated by: Saglik Bilimleri Universitesi
The Effect of Mobile Application-Based Education Given to Patients with Tracheostomy on Depression, Social Adaptation and Quality of Recovery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Effect of Mobile Application-Based Education Given to Patients with Tracheostomy on Depression, Social Adaptation and Quality of Recovery

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Başakşehir Çam and Sakura City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 18 years and older
  • Patients with a tracheostomy
  • Able to communicate verbally or in writing
  • Able to use a smartphone
  • Provided written informed consent

Exclusion Criteria:

  • Presence of severe cognitive impairment
  • Presence of severe psychiatric disorder
  • Patients with neurological diseases affecting swallowing
  • Inability to use a mobile application
  • Refusal to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Participants in this group received standard care plus a mobile application-based education program designed for patients with tracheostomy. The program included educational videos focusing on tracheostomy care, psychosocial support, and postoperative recovery.
Behavioral: Mobile application-based education
A structured education program delivered via a mobile application for patients with tracheostomy. The program included educational videos focusing on tracheostomy care, and postoperative recovery. Participants accessed the content throughout the postoperative period in addition to standard care.
Active Comparator: Control group
Participants in this group received standard postoperative care without access to the mobile application-based education program.
Other: Standart Care
Standard postoperative care routinely provided to patients with tracheostomy according to institutional protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: Baseline and postoperative 21 days
Depression level was assessed using the Beck Depression Inventory. The Beck Depression Inventory is a 21-item self-report questionnaire used to assess the severity of depressive symptoms. Total scores range from 0 to 63, with higher scores indicating greater severity of depressive symptoms
Baseline and postoperative 21 days
Social Adaptation
Time Frame: Baseline and postoperative 21 days
Social adaptation was assessed using the Social Adaptation Self-evaluation Scale. The Social Adaptation Self-Evaluation Scale is a self-report instrument designed to evaluate social functioning and adaptation. Total scores range from 0 to 60, with higher scores indicating better social adaptation and functioning
Baseline and postoperative 21 days
Quality of Recovery
Time Frame: Postoperative 21 days
Quality of recovery was assessed using the Quality of Recovery-40 (QoR-40) questionnaire. The Quality of Recovery-40 is a validated questionnaire assessing postoperative recovery across five dimensions: emotional state, physical comfort, psychological support, physical independence, and pain. Total scores range from 40 to 200, with higher scores indicating better quality of recovery
Postoperative 21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Swallowing Function
Time Frame: Baseline and postoperative 21 days
Swallowing function was assessed using the Turkish version of the Eating Assessment Tool-10 (T-EAT-10).The Turkish Version of the Eating Assessment Tool-10 is a self-administered questionnaire used to assess symptoms of dysphagia. Total scores range from 0 to 40, with higher scores indicating more severe swallowing difficulties
Baseline and postoperative 21 days
Oral Care Status
Time Frame: Postoperative 21 days
Oral care status was assessed using an oral care assessment tool. Total scores range from 8 to 24, with higher scores indicating poorer oral condition
Postoperative 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Actual)

December 25, 2025

Study Completion (Actual)

December 25, 2025

Study Registration Dates

First Submitted

January 4, 2026

First Submitted That Met QC Criteria

January 4, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tracheostomy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to ethical restrictions and to protect participant confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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