- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06865794
Impact of Plastic and Aesthetic Surgery on Self-esteem (QUALIPLAST)
Impact of Plastic and Aesthetic Surgery on Self-esteem, a Prospective Multicentre Study
The primary objective of QUALIPLAST is to evaluate the impact of plastic and aesthetic surgery interventions on patients' self-esteem. While the demand for these procedures is steadily increasing worldwide, patients' motivations often extend beyond purely aesthetic concerns, encompassing significant psychological and emotional expectations. However, despite the growing popularity of these interventions, scientific literature remains limited when it comes to the systematic and long-term evaluation of their effects on patients' self-esteem and overall well-being.
The majority of existing studies focus on short-term outcomes or functional and physical aspects, often overlooking the psychological and emotional dimensions that play a crucial role in post-operative satisfaction. Furthermore, much research is limited to specific procedures, without adopting a comprehensive approach to plastic and aesthetic surgery. This lack of robust and generalisable data hinders a full understanding of how these interventions influence self-esteem across different types of surgeries and patient profiles.
QUALIPLAST stands out due to its multicentric, prospective, and large-scale nature, involving a wide range of procedures and collecting longitudinal data before the intervention, as well as at 3 and 12 months post-operatively. It will allow for the observation of self-esteem changes over time, providing a more complete and nuanced understanding of the effects of surgery.
This project relies on standardized and validated measurement tools, such as the Rosenberg Self-Esteem Scale, to ensure the reliability and comparability of the results. By addressing the current gaps in the literature, QUALIPLAST aims not only to enrich scientific knowledge in this field but also to provide valuable insights for healthcare professionals to improve patient care and tailor clinical practices based on the identified psychological needs.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hugo DESPERT
- Phone Number: +33 6 41 50 23 29
- Email: Hugo.despert@gmail.com
Study Locations
-
-
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Lyon, France, 69002
- Consultation Office of Dr. Emmanuel DELAY
-
Contact:
- Emmanuel DELAY
- Phone Number: +33 4 72 56 07 06
- Email: Emmanuel.delay@lyon.unicancer.fr
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Lyon, France, 69004
- Hospices Civils of Lyon - Croix-Rousse hospital
-
Contact:
- Ali Mojallal, Md, Phd
- Phone Number: +33 4 26 73 28 22
- Email: Alain-Ali.mojallal@chu-lyon.fr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Patients consulting a plastic surgeon for one of the following operations :
- Breast augmentation
- Breast reduction
- Breast lift
- Facelift
- Otoplasty
- Rhinoplasty
- Blepharoplasty
- Abdominoplasty
- Brachioplasty
- Cruroplasty
- Liposuction
- Gender affirmation: breast augmentation
- Gender affirmation: Facial feminisation
- Gender affirmation: Thoracoplasty
- Botox / Hyaluronic acid
Description
Inclusion Criteria:
Patients consulting a plastic surgeon for one of the following operations:
- Breast augmentation
- Breast reduction
- Breast lift
- Facelift
- Otoplasty
- Rhinoplasty
- Blepharoplasty
- Abdominoplasty
- Brachioplasty
- Cruroplasty
- Liposuction
- Gender affirmation: breast augmentation
- Gender affirmation: Facial feminisation
- Gender affirmation: Thoracoplasty
- Botox / Hyaluronic acid
Patients who agreed to take part in the study
Exclusion Criteria:
- Pregnant, parturient or breastfeeding women
- Minors
- Persons deprived of their liberty by a judicial or administrative decision
- Persons receiving psychiatric care
- Persons admitted to a healthcare or social institution for purposes other than research
- Adults under a legal protection measure (guardianship, curators)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Breast augmentation
Adult female patient undergoing breast augmentation for aesthetic reason
|
Rosenberg self-esteem scale pre-operatively, at 3 and 12 months post-op
Other Names:
FACE-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BREAST-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BSIQ-SF pre-operatively, at 3 and 12 months post-op
Other Names:
FLZ psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
|
|
Breast reduction
Adult female patient undergoing breast reduction for aesthetic reason
|
Rosenberg self-esteem scale pre-operatively, at 3 and 12 months post-op
Other Names:
FACE-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BREAST-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BSIQ-SF pre-operatively, at 3 and 12 months post-op
Other Names:
FLZ psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
|
|
Mastopexy
Adult female patient undergoing Mastopexy (Breast lift) for aesthetic reason
|
Rosenberg self-esteem scale pre-operatively, at 3 and 12 months post-op
Other Names:
FACE-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BREAST-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BSIQ-SF pre-operatively, at 3 and 12 months post-op
Other Names:
FLZ psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
|
|
Facelift
Adult patient undergoing facelift for aesthetic reason
|
Rosenberg self-esteem scale pre-operatively, at 3 and 12 months post-op
Other Names:
FACE-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BREAST-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BSIQ-SF pre-operatively, at 3 and 12 months post-op
Other Names:
FLZ psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
|
|
Otoplasty
Adult patient undergoing otoplasty for aesthetic reason
|
Rosenberg self-esteem scale pre-operatively, at 3 and 12 months post-op
Other Names:
FACE-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BREAST-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BSIQ-SF pre-operatively, at 3 and 12 months post-op
Other Names:
FLZ psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
|
|
Rhinoplasty
Adult patient undergoing rhinoplasty for aesthetic reason
|
Rosenberg self-esteem scale pre-operatively, at 3 and 12 months post-op
Other Names:
FACE-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BREAST-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BSIQ-SF pre-operatively, at 3 and 12 months post-op
Other Names:
FLZ psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
|
|
Blepharoplasty
Adult patient undergoing blepharoplasty for aesthetic reason
|
Rosenberg self-esteem scale pre-operatively, at 3 and 12 months post-op
Other Names:
FACE-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BREAST-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BSIQ-SF pre-operatively, at 3 and 12 months post-op
Other Names:
FLZ psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
|
|
Abdominoplasty
Adult patient undergoing abdominoplasty for aesthetic reason
|
Rosenberg self-esteem scale pre-operatively, at 3 and 12 months post-op
Other Names:
FACE-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BREAST-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BSIQ-SF pre-operatively, at 3 and 12 months post-op
Other Names:
FLZ psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
|
|
Brachioplasty
Adult patient undergoing brachioplasty for aesthetic reason
|
Rosenberg self-esteem scale pre-operatively, at 3 and 12 months post-op
Other Names:
FACE-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BREAST-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BSIQ-SF pre-operatively, at 3 and 12 months post-op
Other Names:
FLZ psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
|
|
Thigh lift
Adult patient undergoing thigh lift for aesthetic reason
|
Rosenberg self-esteem scale pre-operatively, at 3 and 12 months post-op
Other Names:
FACE-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BREAST-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BSIQ-SF pre-operatively, at 3 and 12 months post-op
Other Names:
FLZ psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
|
|
Liposuction
Adult patient undergoing liposuction for aesthetic reason
|
Rosenberg self-esteem scale pre-operatively, at 3 and 12 months post-op
Other Names:
FACE-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BREAST-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BSIQ-SF pre-operatively, at 3 and 12 months post-op
Other Names:
FLZ psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
|
|
Gender affirmation: breast augmentation
Adult patient undergoing breast augmentation gender affirmation surgery.
|
Rosenberg self-esteem scale pre-operatively, at 3 and 12 months post-op
Other Names:
FACE-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BREAST-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BSIQ-SF pre-operatively, at 3 and 12 months post-op
Other Names:
FLZ psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
|
|
Gender affirmation: facial feminisation
Adult patient undergoing facial feminisation gender affirmation surgery
|
Rosenberg self-esteem scale pre-operatively, at 3 and 12 months post-op
Other Names:
FACE-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BREAST-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BSIQ-SF pre-operatively, at 3 and 12 months post-op
Other Names:
FLZ psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
|
|
Gender affirmation : thoracoplasty
Adult patient undergoing thoracoplasty gender affirmation surgery
|
Rosenberg self-esteem scale pre-operatively, at 3 and 12 months post-op
Other Names:
FACE-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BREAST-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BSIQ-SF pre-operatively, at 3 and 12 months post-op
Other Names:
FLZ psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
|
|
Injectables/Fillers
Adult patient undergoing Botox or Hyaluronic acid injections for aesthetic reason
|
Rosenberg self-esteem scale pre-operatively, at 3 and 12 months post-op
Other Names:
FACE-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BREAST-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
BSIQ-SF pre-operatively, at 3 and 12 months post-op
Other Names:
FLZ psychological sub-scale pre-operatively, at 3 and 12 months post-op
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-esteem score assessed by the Rosenberg self-esteem scale
Time Frame: Pre-operatively, at 3 and 12 months post-op
|
Self-esteem score assessed by the Rosenberg self-esteem scale
|
Pre-operatively, at 3 and 12 months post-op
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hugo Despert, Hospices Civils of Lyon
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 69HCL25_0154
- 2025-A00418-41 (Other Identifier: ID-RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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