Clinical trial · Observational
Multimedia-assisted Informed Consent Procedure for Patients Undergoing Mastectomy and Implant-based Reconstruction
Effect of a Multimedia-assisted Informed Consent Procedure on the Information Gain, Satisfaction and Anxiety of Patients Undergoing Mastectomy and Implant-based Reconstruction
- 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)
Breast reconstruction is a women's right with positive psychological effects and it is an integral part of breast cancer treatment and care. A preoperative counselling is mandatory, providing information about oncologic surgery, the type of reconstruction and the expected results. This study plans to compare conventional informed consent process supported by informational brochures with a multimedia video-assisted procedure supported by the same informational brochures in breast cancer patients undergoing immediate implant-based reconstruction. The two processes will be compared in terms of information retention, patient satisfaction of the informed consent process and anxiety levels before surgery.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multimedia video | Other | — | UNRESOLVED |
| Standard informed consent procedure | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Standard Informed Consent Procedure
- description
- Face-to-face informed consent procedure supported by an informational brochure approved by the hospital committee
- interventionNames
- Other: Standard informed consent procedure
- label
- Multimedia Assisted Informed Consent Procedure
- description
- Face-to-face informed consent procedure supported by an informational brochure approved by the hospital committee, followed by a multimedia presentation on implant-based reconstruction
- interventionNames
- Other: Standard informed consent procedure
- Other: Multimedia video
Primary outcomes (4)
- measure
- Evaluation of current state of anxiety
- timeFrame
- 2 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing mastectomy for breast cancer * High-risk healthy patients undergoing risk reducing mastectomies * Unilateral and/or bilateral mastectomies * If unilateral mastectomy, both patients requiring or not contralateral mammaplasty of the healthy breast Exclusion Criteria: * Patients undergoing mastectomy and autologous reconstruction * Patients who previously underwent unilateral mastectomy and implant reconstruction, requiring contralateral mastectomy * Patients not available for e-correspondence
References
Publications (0)
Data not yet available