NCT07350616

Brief Summary

Breathing problems after surgery are common and can lead to serious complications such as low oxygen levels, lung collapse, or pulmonary embolism. These problems increase patient risk and place an additional burden on the healthcare system. Breathing exercises and incentive spirometer use are important methods to prevent these complications. However, many patients have difficulty understanding and correctly performing these exercises when education is limited to standard verbal instructions. This randomized controlled study aims to evaluate whether the 5T Teach-Back education method improves patients' understanding, practical skills, respiratory outcomes, and satisfaction compared with standard verbal education. The study will be conducted in a university hospital and will include 76 adult patients undergoing abdominal surgery under general anesthesia. Participants will be randomly assigned to either an intervention group or a control group. Patients in the intervention group will receive preoperative breathing exercise and incentive spirometer training using the 5T Teach-Back method, which encourages patients to explain the information back in their own words and repeat the skills until they are correctly understood. Patients in the control group will receive routine verbal education provided by clinical nurses. Outcomes will be measured before surgery and again within 24-72 hours after surgery. These outcomes include patients' knowledge level, correct performance of breathing exercises and spirometer use, respiratory rate, oxygen saturation, lung function test results, and patient satisfaction with nursing care. The results of this study are expected to show whether the 5T Teach-Back method is more effective than standard education in improving postoperative respiratory care and patient satisfaction. The findings may help standardize patient education practices and support nurses in delivering more effective respiratory training before surgery.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Jan 2026

Status
not yet recruiting

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 Progress31%
Jan 2026Jan 2027

First Submitted

Initial submission to the registry

December 28, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2027

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

December 28, 2025

Last Update Submit

January 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient Knowledge and Correct Performance of Respiratory Exercises and Incentive Spirometer Use

    Patient knowledge and correct performance of respiratory exercises and incentive spirometer use will be assessed using a structured knowledge test and observation-based checklists. Knowledge level will be evaluated with a short multiple-item test, and performance accuracy will be assessed by direct observation of breathing exercises and incentive spirometer use. Higher scores indicate better understanding and correct application of the techniques.

    From baseline (preoperative period) to 24-72 hours postoperatively

Secondary Outcomes (4)

  • Pulmonary Function Test

    24-72 hours postoperatively

  • Patient Satisfaction

    24-72 hours postoperatively

  • Respiratory Parameter (SpO₂)

    From baseline (preoperative period) to 24-72 hours postoperatively

  • Respiratory Rate

    From baseline (preoperative period) to 24-72 hours postoperatively

Study Arms (2)

5T Teach-Back Education Group

EXPERIMENTAL

Participants receive preoperative respiratory exercise and incentive spirometer training using the 5T Teach-Back method.

Behavioral: 5T Teach-Back-Based Respiratory Exercise and Incentive Spirometer Education

Standard Education Group

ACTIVE COMPARATOR

Participants receive routine verbal education on respiratory exercises and incentive spirometer use provided by clinical nurses.

Behavioral: Standard Verbal Respiratory Education

Interventions

This intervention consists of routine verbal education on respiratory exercises and incentive spirometer use provided by clinical nurses as part of standard preoperative care. Education is delivered according to usual clinical practice without a structured teaching framework, return demonstration, or formal assessment of patient understanding. No standardized duration, repetition, or feedback process is applied. This intervention reflects typical routine care and differs from structured educational approaches by relying solely on conventional verbal instruction.

Standard Education Group

This intervention involves preoperative respiratory exercise and incentive spirometer education delivered using the structured 5T Teach-Back method. Education is provided individually by a trained nurse and includes demonstration, patient return demonstration, and repeated instruction until correct understanding and performance are achieved. The five steps of the 5T Teach-Back approach (Triage, Tools, Take Responsibility, Tell Me, and Try Again) are systematically applied to ensure patient comprehension and skill mastery. Sessions last approximately 20-30 minutes and are completed before surgery. Unlike routine verbal education, this intervention actively engages patients in explaining and performing the exercises in their own words, allowing immediate correction of misunderstandings and reinforcing correct technique

5T Teach-Back Education Group

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18 years or older
  • Scheduled for abdominal surgery under general anesthesia
  • Postoperative use of respiratory exercises and incentive spirometry is recommended
  • Expected postoperative hospital stay of more than 3 days
  • Able to read and write and able to communicate effectively
  • Conscious, cooperative, and oriented
  • Willing to participate voluntarily and able to provide written informed consent

You may not qualify if:

  • Severe neurological or cognitive impairment
  • Unstable vital signs or hemodynamic instability
  • Anticipated or required postoperative intensive care unit admission
  • Severe pain that prevents participation in education or assessments
  • Visual or communication impairments that limit participation in education

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Wang J, Hu H, Sun J, Zhang Q, Chen Z, Wang Q, Zhu M, Yao J, Yuan H, Zhang X. The effectiveness of health education based on the 5Ts for teach-back on oral nutritional supplements compliance of post-discharge patients after surgery for gastric cancer: a randomized controlled trial. Support Care Cancer. 2023 Feb 11;31(3):157. doi: 10.1007/s00520-023-07581-1.

    PMID: 36773116BACKGROUND
  • Anderson KM, Leister S, De Rego R. The 5Ts for Teach Back: An Operational Definition for Teach-Back Training. Health Lit Res Pract. 2020 Apr 9;4(2):e94-e103. doi: 10.3928/24748307-20200318-01.

    PMID: 32293689BACKGROUND

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Central Study Contacts

Cigdem Erdem, Assistant Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 28, 2025

First Posted

January 20, 2026

Study Start

January 15, 2026

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

January 15, 2027

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share