NCT07337668

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

April 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2025

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
Last Updated

March 9, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

January 4, 2026

Last Update Submit

March 5, 2026

Conditions

Keywords

mobile applicationtracheostomyeducationquality of recoverydepressionsocial adaptation

Outcome Measures

Primary Outcomes (3)

  • 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

    Baseline and postoperative 21 days

  • 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

    Baseline and postoperative 21 days

  • 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

    Postoperative 21 days

Secondary Outcomes (2)

  • Swallowing Function

    Baseline and postoperative 21 days

  • Oral Care Status

    Postoperative 21 days

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Other: Standart Care

Interventions

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.

Intervention group

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

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basaksehir Cam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 18791882BACKGROUND
  • 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.

    PMID: 27405421BACKGROUND
  • 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.

    PMID: 24428925BACKGROUND
  • 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.

    PMID: 13688369BACKGROUND

MeSH Terms

Conditions

DepressionSocial Adjustment

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSocial Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2026

First Posted

January 13, 2026

Study Start

April 1, 2025

Primary Completion

December 25, 2025

Study Completion

December 25, 2025

Last Updated

March 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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

Locations