NCT07069205

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
Last Updated

July 16, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

July 7, 2025

Last Update Submit

July 7, 2025

Conditions

Keywords

Tele-nursingDyspneaQuality of lifeTelehealth

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline (pre-intervention) and 12 weeks after the intervention.

Study Arms (1)

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.

Behavioral: Tele-nursing supported respiratory exercises

Interventions

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.

Intervention Group

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • Severe respiratory comorbidities preventing exercise participation.
  • Cognitive or communication impairments interfering with tele-nursing.
  • Declines to participate or unable to comply with intervention protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yıldırım Beyazıt Üniversitesi Sağlık Bilimleri Enstitüsü

Ankara, Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tuberculosis, PulmonaryDyspnea

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Canan Güngör, RN

    Ankara Yildirim Beyazıt University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
open-label
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

July 7, 2025

First Posted

July 16, 2025

Study Start

January 10, 2025

Primary Completion

April 11, 2025

Study Completion

April 11, 2025

Last Updated

July 16, 2025

Record last verified: 2025-06

Locations