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CompletedNCT07337668Updated Mar 9, 2026

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

An interventional study of Mobile application-based education and Standart Care in Tracheostomized Patients, Depression and Social Adaptation, sponsored by Saglik Bilimleri Universitesi. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-09.

Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Apr 2025, registered Jan 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Tracheostomized Patients
  • Depression
  • Social Adaptation
  • Quality of Recovery

Keywords

  • mobile application
  • tracheostomy
  • education
  • quality of recovery
  • depression
  • social adaptation
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 45 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Saglik Bilimleri Universitesi is the lead sponsor of 430 studies on the registry; 137 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • 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

  • Active comparator
    Control group

    Participants in this group received standard postoperative care without access to the mobile application-based education program.

    Other: Standart Care

Interventions

  • BehavioralMobile 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.

  • OtherStandart Care

    Standard postoperative care routinely provided to patients with tracheostomy according to institutional protocols

06

What researchers measure

Primary outcomes

  1. Depression

    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

    Time frame: Baseline and postoperative 21 days

  2. Social Adaptation

    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

    Time frame: Baseline and postoperative 21 days

  3. Quality of Recovery

    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

    Time frame: Postoperative 21 days

Secondary outcomes

  1. Swallowing Function

    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

    Time frame: Baseline and postoperative 21 days

  2. Oral Care Status

    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

    Time frame: Postoperative 21 days

07

Study locations

1 site
  • Basaksehir Cam and Sakura City Hospital
    Istanbul, Turkey (Türkiye)
08

References and documents

Publications

  • Akkaya C, Sarandol A, Esen Danaci A, Sivrioglu EY, Kaya E, Kirli S. [Reliability and validity of the Turkish version of the Social Adaptation Self-Evaluation Scale (SASS)]. Turk Psikiyatri Derg. 2008 Fall;19(3):292-9. Turkish. PubMed 18791882 ↗
  • Demir N, Serel Arslan S, Inal O, Karaduman AA. Reliability and Validity of the Turkish Eating Assessment Tool (T-EAT-10). Dysphagia. 2016 Oct;31(5):644-9. doi: 10.1007/s00455-016-9723-9. Epub 2016 Jul 12. PubMed 27405421 ↗
  • Karaman S, Arici S, Dogru S, Karaman T, Tapar H, Kaya Z, Suren M, Gurler Balta M. Validation of the Turkish version of the Quality of Recovery-40 questionnaire. Health Qual Life Outcomes. 2014 Jan 15;12:8. doi: 10.1186/1477-7525-12-8. PubMed 24428925 ↗
  • BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available. PubMed 13688369 ↗

Individual participant data

Plan to share: No — Individual participant data will not be shared due to ethical restrictions and to protect participant confidentiality.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07337668
Lead sponsor
Saglik Bilimleri Universitesi
Responsible party
Sponsor
First posted
Jan 13, 2026
Start date
Apr 1, 2025
Primary completion
Dec 25, 2025
Completion
Dec 25, 2025
Last update
Mar 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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