Self EsteemQUALIPLASTNCT06865794
Impact of Plastic and Aesthetic Surgery on Self-esteem
An observational study of Self Esteem, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Self Esteem
- What is being tested?
- Questionnaire and Physical Exam
- Type of treatment
- Injection or infusion
- How many people
- 1,500 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Apr 2025to 15 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients consulting a plastic surgeon for one of the following operations:
- Breast augmentation
- Breast reduction
- Breast lift
- Facelift
- Otoplasty
Show all 17Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Consultation Office of Dr. Emmanuel DELAY
Lyon, 69002
Emmanuel DELAY, +33 4 72 56 07 06, Emmanuel.delay@lyon.unicancer.fr
Hospices Civils of Lyon - Croix-Rousse hospital
Lyon, 69004
Ali Mojallal, Md, Phd, +33 4 26 73 28 22, Alain-Ali.mojallal@chu-lyon.fr
About this study
Official title: 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.
Read more
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.
- Conditions
- Self Esteem
- Being tested
- Questionnaire and Physical Exam
- Keywords
- plastic surgery, cosmetic surgery, aesthetic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Physical ExamOther
Also called Rosenberg self-esteem scale
Rosenberg self-esteem scale pre-operatively, at 3 and 12 months post-op
Questionnaire and Physical ExamOther
Also called FACE-Q psychological sub-scale
FACE-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Questionnaire and Physical ExamOther
Also called BREAST-Q psychological sub-scale
BREAST-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op
Questionnaire and Physical ExamOther
Also called BSIQ-SF (short-form version of the Body Self-Image Questionnaire)
BSIQ-SF pre-operatively, at 3 and 12 months post-op
Questionnaire and Physical ExamOther
Also called FLZ (Fragen zur Lebenszufriedenheit / Questions on Life Satisfaction) psychological sub-scale
FLZ psychological sub-scale pre-operatively, at 3 and 12 months post-op
| Study group | Role | What they receive |
|---|---|---|
| Breast augmentation | Adult female patient undergoing breast augmentation for aesthetic reason Receives: Other: Questionnaire and Physical Exam | |
| Breast reduction | Adult female patient undergoing breast reduction for aesthetic reason Receives: Other: Questionnaire and Physical Exam | |
| Mastopexy | Adult female patient undergoing Mastopexy (Breast lift) for aesthetic reason Receives: Other: Questionnaire and Physical Exam | |
| Facelift | Adult patient undergoing facelift for aesthetic reason Receives: Other: Questionnaire and Physical Exam | |
| Otoplasty | Adult patient undergoing otoplasty for aesthetic reason Receives: Other: Questionnaire and Physical Exam | |
| Rhinoplasty | Adult patient undergoing rhinoplasty for aesthetic reason Receives: Other: Questionnaire and Physical Exam | |
| Blepharoplasty | Adult patient undergoing blepharoplasty for aesthetic reason Receives: Other: Questionnaire and Physical Exam | |
| Abdominoplasty | Adult patient undergoing abdominoplasty for aesthetic reason Receives: Other: Questionnaire and Physical Exam | |
| Brachioplasty | Adult patient undergoing brachioplasty for aesthetic reason Receives: Other: Questionnaire and Physical Exam | |
| Thigh lift | Adult patient undergoing thigh lift for aesthetic reason Receives: Other: Questionnaire and Physical Exam | |
| Liposuction | Adult patient undergoing liposuction for aesthetic reason Receives: Other: Questionnaire and Physical Exam | |
| Gender affirmation: breast augmentation | Adult patient undergoing breast augmentation gender affirmation surgery. Receives: Other: Questionnaire and Physical Exam | |
| Gender affirmation: facial feminisation | Adult patient undergoing facial feminisation gender affirmation surgery Receives: Other: Questionnaire and Physical Exam | |
| Gender affirmation : thoracoplasty | Adult patient undergoing thoracoplasty gender affirmation surgery Receives: Other: Questionnaire and Physical Exam | |
| Injectables/Fillers | Adult patient undergoing Botox or Hyaluronic acid injections for aesthetic reason Receives: Other: Questionnaire and Physical Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-esteem score assessed by the Rosenberg self-esteem scale
Self-esteem score assessed by the Rosenberg self-esteem scale
Measured: Pre-operatively, at 3 and 12 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start15 Apr 2025 (estimated)
- Primary completion15 Oct 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self EsteemStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugo Despert, Principal investigator, Hospices Civils of Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865794
- Sponsor's protocol ID
- 69HCL25_0154
- Other IDs
- 2025-A00418-41
- Acronym
- QUALIPLAST
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Plastic and Aesthetic Surgery on Self-esteem, a Prospective Multicentre Study
- ClinicalTrials.gov ID
- NCT06865794
- Acronym / sponsor ID
- QUALIPLAST / 69HCL25_0154
- Conditions
- Self Esteem
- Keywords
- plastic surgery, cosmetic surgery, aesthetic surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| Breast augmentation | – | Other: Questionnaire and Physical ExamAdult female patient undergoing breast augmentation for aesthetic reason |
| Breast reduction | – | Other: Questionnaire and Physical ExamAdult female patient undergoing breast reduction for aesthetic reason |
| Mastopexy | – | Other: Questionnaire and Physical ExamAdult female patient undergoing Mastopexy (Breast lift) for aesthetic reason |
| Facelift | – | Other: Questionnaire and Physical ExamAdult patient undergoing facelift for aesthetic reason |
| Otoplasty | – | Other: Questionnaire and Physical ExamAdult patient undergoing otoplasty for aesthetic reason |
| Rhinoplasty | – | Other: Questionnaire and Physical ExamAdult patient undergoing rhinoplasty for aesthetic reason |
| Blepharoplasty | – | Other: Questionnaire and Physical ExamAdult patient undergoing blepharoplasty for aesthetic reason |
| Abdominoplasty | – | Other: Questionnaire and Physical ExamAdult patient undergoing abdominoplasty for aesthetic reason |
| Brachioplasty | – | Other: Questionnaire and Physical ExamAdult patient undergoing brachioplasty for aesthetic reason |
| Thigh lift | – | Other: Questionnaire and Physical ExamAdult patient undergoing thigh lift for aesthetic reason |
| Liposuction | – | Other: Questionnaire and Physical ExamAdult patient undergoing liposuction for aesthetic reason |
| Gender affirmation: breast augmentation | – | Other: Questionnaire and Physical ExamAdult patient undergoing breast augmentation gender affirmation surgery. |
| Gender affirmation: facial feminisation | – | Other: Questionnaire and Physical ExamAdult patient undergoing facial feminisation gender affirmation surgery |
| Gender affirmation : thoracoplasty | – | Other: Questionnaire and Physical ExamAdult patient undergoing thoracoplasty gender affirmation surgery |
| Injectables/Fillers | – | Other: Questionnaire and Physical ExamAdult patient undergoing Botox or Hyaluronic acid injections for aesthetic reason |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (17 listed)
- Breast augmentation
- Breast reduction
- Breast lift
- Facelift
- Otoplasty
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire and Physical ExamAlso: Rosenberg self-esteem scaleRosenberg self-esteem scale pre-operatively, at 3 and 12 months post-op | Other | Abdominoplasty, Blepharoplasty, Brachioplasty, Breast augmentation, Breast reduction, Facelift, Gender affirmation : thoracoplasty, Gender affirmation: breast augmentation, Gender affirmation: facial feminisation, Injectables/Fillers, Liposuction, Mastopexy, Otoplasty, Rhinoplasty, Thigh lift |
| Questionnaire and Physical ExamAlso: FACE-Q psychological sub-scaleFACE-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op | Other | Blepharoplasty, Facelift, Injectables/Fillers, Otoplasty, Rhinoplasty |
| Questionnaire and Physical ExamAlso: BREAST-Q psychological sub-scaleBREAST-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op | Other | Breast augmentation, Breast reduction, Mastopexy |
| Questionnaire and Physical ExamAlso: BSIQ-SF (short-form version of the Body Self-Image Questionnaire)BSIQ-SF pre-operatively, at 3 and 12 months post-op | Other | Abdominoplasty, Brachioplasty, Liposuction, Thigh lift |
| Questionnaire and Physical ExamAlso: FLZ (Fragen zur Lebenszufriedenheit / Questions on Life Satisfaction) psychological sub-scaleFLZ psychological sub-scale pre-operatively, at 3 and 12 months post-op | Other | Gender affirmation : thoracoplasty, Gender affirmation: breast augmentation, Gender affirmation: facial feminisation |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hugo Despert principal investigator
Hospices Civils of Lyon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Self Esteem, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hugo DESPERT (+33 6 41 50 23 29, Hugo.despert@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-esteem score assessed by the Rosenberg self-esteem scale (time frame: Pre-operatively, at 3 and 12 months post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.