Clinical trial · Interventional
The Effect of Digital Technology-Supported Education on Patients Undergoing Breast Reconstruction After Mastectomy: A Randomized Controlled Study
The Effect of Digital Technology-Supported Education and Monitoring on Anxiety, Pain, Sleep and Quality of Life in Patients Undergoing Immediate Breast Reconstruction After Mastectomy: A Randomized Controlled Study
NCT06166953CI-TRIAL-00082042recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this randomized, controlled study is to test the effectiveness of digital technology-supported education on patients undergoing breast reconstruction after mastectomy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| digital technology-supported education | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- mobile application
- description
- The mobile application will be downloaded on smart phones of participants. This group will be able to look up information related to surgical period when needed.
- interventionNames
- Other: digital technology-supported education
- type
- NO_INTERVENTION
- label
- Control
- description
- The control group will receive routine care. This group will wear smart band for pulse rate, sleep, blood pressure, and SpO2 record for data collection times.
Primary outcomes (4)
- measure
- Anxiety
- timeFrame
- Baseline and 30th days
- description
- The Hospital Anxiety and Depression Scale will be used. It is a valid and reliable scale in Turkish. The higher score the higher risk for depression or anxiety. (Change from baseline to 5th, 15th and 30th days will be assessed).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Being diagnosed with stage 1, 2, or 3 breast cancer * Planned to undergo immediate breast reconstruction after mastectomy for the first time * Being between 18 to 75 years old * Able to use smart phone * Having smart phone with Android v5.0 or iOS v9.0 and above software, Bluetooth and internet connection * Having no hearing or visual impairment * Having no physical limitation * Turkish speaking volunteers Exclusion Criteria: * Patients planned to undergo total abdominal hysterectomy and bilateral salpingo oophorectomy with immediate reconstruction after mastectomy
References
Publications (0)
Data not yet available
No reference posted for this study.