Tracheostomized PatientsNCT07337668
The Effect of Mobile Application-Based Education Given to Patients With Tracheostomy on Depression, Social Adaptation and Quality of Recovery
A study testing Mobile application-based education and Standart Care in people with Tracheostomized Patients and Depression, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The Effect of Mobile Application-Based Education Given to Patients with Tracheostomy on Depression, Social Adaptation and Quality of Recovery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomized Patients, Depression, Social Adaptation
- What is being tested?
- Mobile application-based education and Standart Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 25 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Basaksehir Cam and Sakura City Hospital
Istanbul
About this study
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
- Being tested
- Mobile application-based education, Standart Care
- Keywords
- mobile application, tracheostomy, education, quality of recovery, depression, social adaptation
- Medical subject headings
- Depression, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile application-based educationBehavioural
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.
Standart CareOther
Standard postoperative care routinely provided to patients with tracheostomy according to institutional protocols
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standart Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Postoperative 21 days
Secondary outcomes (2)
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
Measured: Baseline and postoperative 21 days
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
Measured: Postoperative 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Apr 2025
- Primary completion25 Dec 2025
- Study completion25 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tracheostomized PatientsStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337668
- Sponsor's protocol ID
- Tracheostomy
- Status last verified
- Jan 2026
- First submitted
- 4 Jan 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical restrictions and to protect participant confidentiality.
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 18791882Demir 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 27405421Karaman 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 24428925BECK 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobile Application-Based Education Given to Patients With Tracheostomy on Depression, Social Adaptation and Quality of Recovery
- ClinicalTrials.gov ID
- NCT07337668
- Acronym / sponsor ID
- Tracheostomy
- Keywords
- mobile application, tracheostomy, education, quality of recovery, depression, social adaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 25 Dec 2025 (actual)
- Study completion
- 25 Dec 2025 (actual)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Effect of Mobile Application-Based Education Given to Patients with Tracheostomy on Depression, Social Adaptation and Quality of Recovery
Detailed description
The Effect of Mobile Application-Based Education Given to Patients with Tracheostomy on Depression, Social Adaptation and Quality of Recovery
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Mobile application-based educationParticipants 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. |
| Control group | Active comparator | Other: Standart CareParticipants in this group received standard postoperative care without access to the mobile application-based education program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile application-based educationA 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. | Behavioural | Intervention group |
| Standart CareStandard postoperative care routinely provided to patients with tracheostomy according to institutional protocols | Other | Control group |
Primary outcome
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
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
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
2 secondary outcomes
Swallowing Function
Time frame: Baseline and postoperative 21 days
Oral Care Status
Time frame: Postoperative 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Background: PubMed 18791882Akkaya 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.
- Background: PubMed 27405421Demir 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.
- Background: PubMed 24428925Karaman 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.
- Background: PubMed 13688369BECK 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical restrictions and to protect participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application-based education and Standart Care in people with Tracheostomized Patients and Depression, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: Baseline and postoperative 21 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07337668, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.