Impaired Quality of LifeTELEBREATHNCT07069205
Breathing Exercise and Tele-Nursing Support for Patients With Tuberculosis: A Single-Group Experimental Study
A study testing Tele-nursing supported respiratory exercises in people with Impaired Quality of Life and Pulmonary Tuberculosis (TB), run by Canan Güngör at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted as a single-group, pretest-posttest quasi-experimental design. The sample consisted of 54 tuberculosis patients registered at a Tuberculosis Dispensary who met the inclusion criteria and agreed to participate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Impaired Quality of Life, Pulmonary Tuberculosis (TB)
- What is being tested?
- Tele-nursing supported respiratory exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2025to 11 Apr 2025
- Phase
- Interventional
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
- Diagnosed with tuberculosis and registered at a Tuberculosis Dispensary.
- Meets criteria for study participation.
- Provides informed consent.
- Able to participate in tele-nursing supported respiratory exercises and follow-up.
Who cannot join
- Severe respiratory comorbidities preventing exercise participation.
- Cognitive or communication impairments interfering with tele-nursing.
- Declines to participate or unable to comply with intervention protocol.
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt Üniversitesi Sağlık Bilimleri Enstitüsü
Ankara, Ankara, 06000
About this study
Official title: "The Effect of Breathing Exercise Education and Follow-Up Supported by Tele-Nursing on Dyspnea and Quality of Life in Patients With Tuberculosis: A Single-Group Experimental Study"
This study was conducted as a single-group, pretest-posttest quasi-experimental design. The sample consisted of 54 tuberculosis patients registered at a Tuberculosis Dispensary who met the inclusion criteria and agreed to participate. Data collection tools included the Patient Identification Form, Dyspnea-12 TR Scale, Multidimensional Quality of Life Scale (MILQ), London Chest Activities of Daily Living Scale (LCADL), Tele-Nursing Follow-up Form, and Tele-Nursing Evaluation Form. Descriptive statistics, paired sample t-test, and Wilcoxon Signed-Rank Test were used for data analysis. The intervention group received structured respiratory exercises training, including abdominal breathing, pursed-lip breathing, and effective coughing, through educational materials (booklet and videos) developed by the researcher. Patients were regularly monitored for 12 weeks via phone calls and video conferencing. Baseline assessments were conducted using data collection tools at the first visit, and post-intervention assessments were performed at the end of week 12 to evaluate the effectiveness of the intervention.
Read the detailed description
This study implemented a structured respiratory exercise intervention supported by tele-nursing to assess its impact on dyspnea severity and quality of life among patients diagnosed with tuberculosis. The intervention included abdominal breathing, pursed-lip breathing, and effective coughing techniques delivered through a combination of printed educational booklets and instructional videos. These materials were specifically developed for the study and validated by expert healthcare professionals to ensure content accuracy and cultural appropriateness.
Patients were monitored remotely over a 12-week period with scheduled weekly follow-up sessions conducted via telephone and video calls. These sessions facilitated reinforcement of the respiratory exercises, addressed patient inquiries, and enabled continuous assessment of adherence and response to the intervention. Data collection instruments, including validated Turkish versions of the Dyspnea-12 scale, the Multidimensional Quality of Life Scale (MILQ), and the London Chest Activities of Daily Living Scale (LCADL), were employed to quantitatively measure changes in respiratory symptoms, functional capacity, and overall quality of life.
Comprehensive data management protocols were followed to ensure confidentiality and data integrity throughout the study period. Statistical analyses were performed using appropriate parametric and non-parametric tests based on data distribution, including paired-sample t-tests and Wilcoxon Signed-Rank tests, to evaluate the pre- and post-intervention effects.
Ethical approval was obtained from the relevant institutional review board, and all participants provided informed consent prior to inclusion. This research contributes valuable insights into the feasibility and effectiveness of telehealth-supported respiratory therapy interventions in tuberculosis care, highlighting the potential of patient-centered, remotely delivered nursing practices to enhance treatment outcomes.
- Being tested
- Tele-nursing supported respiratory exercises
- Keywords
- Tele-nursing, Dyspnea, Quality of life, Telehealth
- Medical subject headings
- Tuberculosis, Pulmonary, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-nursing supported respiratory exercisesBehavioural
This intervention consists of a structured tele-nursing supported respiratory exercise program including abdominal breathing, pursed-lip breathing, and effective coughing techniques. The training is delivered through educational booklets and videos over a 12-week period, aiming to improve respiratory function and patient self-management in tuberculosis patients.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants receive tele-nursing supported respiratory exercises including abdominal breathing, pursed-lip breathing, and effective coughing training supported by educational booklets and videos over a 12-week period. Receives: Behavioral: Tele-nursing supported respiratory exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dyspnea Severity Using the Dispne-12 Turkish Version Scale
This outcome measures the change in dyspnea severity in tuberculosis patients before and after receiving tele-nursing supported respiratory exercise training over 12 weeks, using the validated Dispne-12 TR scale.
Measured: Baseline and at 12 weeks post-intervention
Change in Dyspnea Severity (Dispne-12 TR Scale)
The change in dyspnea severity will be measured using the Dispne-12 Turkish version scale to assess the effectiveness of tele-nursing supported respiratory exercises on patients with tuberculosis over a 12-week period.
Measured: Baseline (pre-intervention) and 12 weeks after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start10 Jan 2025
- Primary completion11 Apr 2025
- Study completion11 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Quality of LifeStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study was conducted using a single-group pretest-posttest quasi-experimental design. All participants received the same structured respiratory exercise training and tele-nursing follow-up for 12 weeks.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canan Güngör
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Canan Güngör, Ankara Yildirim Beyazıt University
- Investigators
- Canan Güngör, RN, Study chair, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069205
- Sponsor's protocol ID
- GUNGOR2025-TELEHEM
- Other IDs
- "03-663"
- Acronym
- TELEBREATH
- Status last verified
- Jun 2025
- First submitted
- 7 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No