Postoperative PainNCT06707818
Psychosocial Factors and Postoperative Pain in Aesthetic Breast Surgery
An observational study of Postoperative Pain and Psychological Factors, run by V.K.V. American Hospital, Istanbul at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the relationship between psychosocial factors, particularly self-esteem and personality traits, and postoperative pain in patients undergoing aesthetic breast surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Psychological Factors, Breast Surgery
- What is being tested?
- Preoperative Interventions, Intraoperative Interventions and Postoperative Interventions
- Type of treatment
- Injection or infusion
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2024to 10 Jan 2026
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for aesthetic breast surgery between January 2024 and January 2025 will be informed about the study and invited to participate.
Who may be able to join
- 18 years or older
- Have an American Society of Anesthesiologists (ASA) physical status classification of 1-3.
Who cannot join
- under the age of 18,
- have an ASA status of 4,
- history of anxiety disorders and/or psychological conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychosocial Factors and Postoperative Pain in Aesthetic Breast Surgery: A Prospective Observational Study
This study investigates the relationship between psychosocial factors, particularly self-esteem and personality traits, and postoperative pain in patients undergoing aesthetic breast surgery. Previous research suggests that psychological factors like depression, anxiety, and low self-esteem may influence pain perception. The study aims to contribute to personalized pain management strategies for these patients.
A prospective, observational cohort study will be conducted at VKV American Hospital from January 2024 to January 2025. Eligible participants (18+ years old, ASA status 1-3) will be assessed preoperatively using validated scales for self-esteem, personality traits, anxiety, depression, and pain perception. Intraoperative procedures will follow a standardized anesthesia protocol, with pain and recovery data collected postoperatively. Pain scores and medication usage will be recorded, and patient satisfaction will be assessed using the Quality of Recovery-15 scale.
This study seeks to enhance understanding of psychological influences on postoperative pain, potentially improving pain management protocols for aesthetic surgery patients.
Read the detailed description
INTRODUCTION Pain is an unpleasant experience associated with actual or potential tissue damage, involving sensory, emotional, cognitive, and social components (1). There are studies in the literature that examine the relationship between postoperative acute pain and psychological factors (2, 3). For example, studies in cancer patients undergoing reconstructive breast surgery have shown that depression, anxiety levels, and abnormal pain perception (pain catastrophizing) are associated with postoperative pain (4). Psychological factors that could influence pain in aesthetic surgeries may be more diverse. Self-esteem and personality types are among the psychological factors that could affect pain.
Self-esteem refers to an individual's beliefs and perceptions about themselves. It plays a significant role in shaping an individual's thoughts about their physical appearance. People with low self-esteem are generally dissatisfied with their appearance, which may lead them to seek aesthetic surgery as a way to improve their self-worth. Low self-esteem has been associated with an increased likelihood of undergoing aesthetic surgery (5). Furthermore, aesthetic surgeries have been linked to significant improvements in self-esteem. A systematic review conducted by Javo and colleagues (2019) showed that more than 70% of aesthetic surgery patients experienced significant increases in self-esteem (6).
Another factor that could be related to pain is personality traits. Studies have shown that personality traits are important predictors of postoperative pain and complications in aesthetic surgeries (7). Traits such as perfectionism, neuroticism, and anxiety have been associated with increased postoperative pain and poor surgical outcomes. Individuals with these traits may experience anxiety and fear before surgery, leading to a lower pain threshold and increased sensitivity to pain sensations.
Aesthetic surgery is a rapidly growing industry worldwide. The desire for physical recovery and maintaining a youthful appearance has led to an increase in demand for aesthetic surgeries. However, the psychological effects of these surgeries and their relationship with pain have not been fully investigated. The aim of our study is to examine the relationship between psychosocial factors, particularly self-esteem and personality types, and postoperative pain in patients undergoing aesthetic breast surgery. This study is expected to contribute to the literature on developing personalized pain management strategies for aesthetic surgery patients.
To investigate the relationship between self-esteem, personality types, other psychosocial factors, and postoperative pain in patients undergoing aesthetic breast surgery. To contribute to the literature on the development of personalized pain protocols for aesthetic surgery patients.
METHOD After obtaining ethical approval from the Koç University Committee on Human Research, with approval number [2023.305.IRB1.101], a prospective, observational cohort study will be conducted at VKV American Hospital. Patients scheduled for aesthetic breast surgery between January 2024 and January 2025 will be informed about the study and invited to participate. Participants eligible for inclusion in the study must be aged 18 years or older and have an American Society of Anesthesiologists (ASA) physical status classification of 1-3. Individuals will be excluded if they are under the age of 18, have an ASA status of 4, decline to participate, or have a history of anxiety disorders and/or psychological conditions.
The study will include three main phases: preoperative, intraoperative, and postoperative periods. The data collected from these periods will be used to evaluate perioperative outcomes, including pain management efficacy, recovery quality, and overall patient satisfaction.
- Preoperative Period: One week before surgery, during the initial surgical consultation, participants will provide informed consent. Demographic data and several validated assessment scales will be collected, including the Perceived Socioeconomic Status Scale (8), Ten-Item Personality Inventory (9), Pain Catastrophizing Scale (10), Hospital Anxiety and Depression Scale (11), Rosenberg Self-Esteem Scale (12), Quality of Recovery-15 (QoR-15) questionnaire (13), and the Visual Analog Scale (VAS) for pain (14).
- Intraoperative Period: All surgical procedures will follow the standard general anesthesia protocol of the hospital. General anesthesia induction will involve propofol (1-2 mg/kg), fentanyl (1 mcg/kg), and rocuronium (0.6 mg/kg) for endotracheal intubation. Anesthesia maintenance will be performed with desflurane (4-6%) and remifentanil (0.1 mcg/kg/min), with adjustments as needed based on blood pressure and heart rate. Post-induction, dexamethasone (4 mg) will be administered for anti-inflammatory effects. To support postoperative pain management, tramadol (1 mg/kg), ibuprofen (400 mg), and paracetamol (1 g) will be administered before the end of the procedure. Ondansetron (4 mg) will be used for nausea prophylaxis. All intraoperative medications and dosages will be recorded without intervention.
- Postoperative Period:
In the recovery room, pain scores will be recorded at 0, 30, and 60 minutes postoperatively by blinded nurses. Analgesic interventions will follow the hospital's standard protocol: patients with VAS scores between 3 and 7 will receive 25 mcg of fentanyl, while those with scores above 7 will receive 50 mcg. The total fentanyl dosage and any side effects, such as nausea, respiratory difficulty, or shivering, will be documented.
All patients will receive standard multimodal analgesia during the ward stay, including paracetamol (1 g, three times daily) and ibuprofen (400 mg, twice daily). Patient-controlled analgesia (PCA) devices will administer tramadol (10 mg IV per patient request, without continuous infusion). Data on VAS scores at 6 and 24 hours postoperatively, as well as the total tramadol dosage administered via PCA, will be recorded. Additionally, participants' satisfaction with pain management will be assessed using the Quality of Recovery-15 scale at 24 hours postoperatively.
- Conditions
- Postoperative Pain, Psychological Factors, Breast Surgery, Aesthetic Surgery, Anesthesia, General, Quality of Recovery (QoR-15)
- Being tested
- Preoperative Interventions, Intraoperative Interventions, Postoperative Interventions
- Keywords
- Postoperative pain, Aesthetic breast surgery, psychosocial factors, pain management
- Medical subject headings
- Pain, Postoperative, Patient Satisfaction, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative InterventionsOther
During the initial surgical consultation, participants will provide informed consent. Demographic data and several validated assessment scales will be collected, including the Perceived Socioeconomic Status Scale (8), Ten-Item Personality Inventory (9), Pain Catastrophizing Scale (10), Hospital Anxiety and Depression Scale (11), Rosenberg Self-Esteem Scale (12), Quality of Recovery-15 (QoR-15) questionnaire (13), and the Visual Analog Scale (VAS) for pain (14).
Intraoperative InterventionsOther
All surgical procedures will follow the standard general anesthesia protocol of the hospital. General anesthesia induction will involve propofol (1-2 mg/kg), fentanyl (1 mcg/kg), and rocuronium (0.6 mg/kg) for endotracheal intubation. Anesthesia maintenance will be performed with desflurane (4-6%) and remifentanil (0.1 mcg/kg/min), with adjustments as needed based on blood pressure and heart rate. Post-induction, dexamethasone (4 mg) will be administered for anti-inflammatory effects. To support postoperative pain management, tramadol (1 mg/kg), ibuprofen (400 mg), and paracetamol (1 g) will be administered before the end of the procedure. Ondansetron (4 mg) will be used for nausea prophylaxis. All intraoperative medications and dosages will be recorded without intervention.
Postoperative InterventionsOther
In the recovery room, analgesic interventions will follow the hospital's standard protocol: patients with VAS scores between 3 and 7 will receive 25 mcg of fentanyl, while those with scores above 7 will receive 50 mcg.
All patients will receive standard multimodal analgesia during the ward stay, including paracetamol (1 g, three times daily) and ibuprofen (400 mg, twice daily). Patient-controlled analgesia (PCA) devices will administer tramadol (10 mg IV per patient request, without continuous infusion).
| Study group | Role | What they receive |
|---|---|---|
| Patients scheduled for aesthetic breast surgery | This group includes patients undergoing aesthetic breast surgery between January 2024 and January 2025 who are assessed preoperatively, intraoperatively, and postoperatively. Receives: Other: Preoperative Interventions; Other: Intraoperative Interventions; Other: Postoperative Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Participants' satisfaction with pain management will be assessed using the Quality of Recovery-15 scale preoperatively and 24 hours postoperatively.
The QoR-15 test scores responses on a scale where 10 represents "always," and 0 means "never." The test has a maximum possible score of 150 and a minimum of 0. QoR-15 scores are classified into the following categories: excellent (QoR-15 > 135), good (122 ≤ QoR-15 ≤ 135), moderate (90 ≤ QoR-15 ≤ 121), and poor (QoR-15 < 90).
Measured: Preoperatively and 24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start15 Apr 2024
- Primary completion15 Dec 2025
- Study completion10 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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
- 52 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- V.K.V. American Hospital, Istanbul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Tümer, MD, V.K.V. American Hospital, Istanbul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707818
- Sponsor's protocol ID
- PostopPainAndPsychology
- Status last verified
- Jan 2026
- First submitted
- 24 Nov 2024
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All shared data will be de-identified to protect participant confidentiality, and access will be granted only to researchers who meet the necessary criteria and ethical standards for data use.
Publications
Çuhadaroğlu, F. (1986). Adolesanlarda benlik saygısı. Yayınlanmamış uzmanlık tezi. Hacettepe Üniversitesi.
Miller MD, Ferris DG. Measurement of subjective phenomena in primary care research: the Visual Analogue Scale. Fam Pract Res J. 1993 Mar;13(1):15-24.
PubMed 8484338Kara U, Simsek F, Kamburoglu H, Ozhan MO, Alakus U, Ince ME, Eksert S, Ozkan G, Eskin MB, Senkal S. Linguistic validation of a widely used recovery score: quality of recovery-15 (QoR-15). Turk J Med Sci. 2022 Apr;52(2):427-435. doi: 10.55730/1300-0144.5330. Epub 2022 Apr 14.
PubMed 36161615Karakas Ugurlu G, Ugurlu M, Erten S, Can SS, Ulusoy Kaymak S, Caykoylu A. Effect of familial Mediterranean fever on sexual and reproductive health in women. Turk J Med Sci. 2017 Apr 18;47(2):463-469. doi: 10.3906/sag-1602-88.
PubMed 28425232Aydemir, O. J. T. P. D. (1997). Hastane anksiyete ve depresyon olcegi Turkce formunun gecerlilik ve guvenilirligi. Turk Psikiyatri Derg., 8, 187-280.
Atak, H. (2013). On-Maddeli Kişilik Ölçeği'nin Türk Kültürü'ne Uyarlanması. Archives of Neuropsychiatry/Nöropsikiyatri Arşivi, 50(4).
Adler NE, Epel ES, Castellazzo G, Ickovics JR. Relationship of subjective and objective social status with psychological and physiological functioning: preliminary data in healthy white women. Health Psychol. 2000 Nov;19(6):586-92. doi: 10.1037//0278-6133.19.6.586.
PubMed 11129362Schreiber KL, Zinboonyahgoon N, Xu X, Spivey T, King T, Dominici L, Partridge A, Golshan M, Strichartz G, Edwards RR. Preoperative Psychosocial and Psychophysical Phenotypes as Predictors of Acute Pain Outcomes After Breast Surgery. J Pain. 2019 May;20(5):540-556. doi: 10.1016/j.jpain.2018.11.004. Epub 2018 Nov 23.
PubMed 30476655Kam O, Na S, La Sala M, Tejeda CI, Koola MM. The Psychological Benefits of Cosmetic Surgery. J Nerv Ment Dis. 2022 Jul 1;210(7):479-485. doi: 10.1097/NMD.0000000000001477.
PubMed 35766540Honigman RJ, Phillips KA, Castle DJ. A review of psychosocial outcomes for patients seeking cosmetic surgery. Plast Reconstr Surg. 2004 Apr 1;113(4):1229-37. doi: 10.1097/01.prs.0000110214.88868.ca.
PubMed 15083026Kulkarni AR, Pusic AL, Hamill JB, Kim HM, Qi J, Wilkins EG, Roth RS. Factors Associated with Acute Postoperative Pain Following Breast Reconstruction. JPRAS Open. 2017 Mar;11:1-13. doi: 10.1016/j.jpra.2016.08.005. Epub 2016 Sep 15.
PubMed 28713853Bradshaw P, Hariharan S, Chen D. Does preoperative psychological status of patients affect postoperative pain? A prospective study from the Caribbean. Br J Pain. 2016 May;10(2):108-15. doi: 10.1177/2049463716635680. Epub 2016 Mar 2.
PubMed 27551421Aglio LS, Mezzalira E, Mendez-Pino L, Corey SM, Fields KG, Abbakar R, Baez LA, Kelly-Aglio NJ, Vetter T, Jamison RN, Edwards RR. Surgical Prehabilitation: Strategies and Psychological Intervention to Reduce Postoperative Pain and Opioid Use. Anesth Analg. 2022 May 1;134(5):1106-1111. doi: 10.1213/ANE.0000000000005963. No abstract available.
PubMed 35427271Williams ACC, Craig KD. Updating the definition of pain. Pain. 2016 Nov;157(11):2420-2423. doi: 10.1097/j.pain.0000000000000613. No abstract available.
PubMed 27200490
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Factors and Postoperative Pain in Aesthetic Breast Surgery: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06707818
- Acronym / sponsor ID
- PostopPainAndPsychology
- Conditions
- Postoperative Pain, Psychological Factors, Breast Surgery, Aesthetic Surgery, Anesthesia, General, Quality of Recovery (QoR-15)
- Keywords
- Postoperative pain, Aesthetic breast surgery, psychosocial factors, pain management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- V.K.V. American Hospital, IstanbulUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 27 Nov 2024 (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.
This study investigates the relationship between psychosocial factors, particularly self-esteem and personality traits, and postoperative pain in patients undergoing aesthetic breast surgery. Previous research suggests that psychological factors like depression, anxiety, and low self-esteem may influence pain perception. The study aims to contribute to personalized pain management strategies for these patients.
A prospective, observational cohort study will be conducted at VKV American Hospital from January 2024 to January 2025. Eligible participants (18+ years old, ASA status 1-3) will be assessed preoperatively using validated scales for self-esteem, personality traits, anxiety, depression, and pain perception. Intraoperative procedures will follow a standardized anesthesia protocol, with pain and recovery data collected postoperatively. Pain scores and medication usage will be recorded, and patient satisfaction will be assessed using the Quality of Recovery-15 scale.
This study seeks to enhance understanding of psychological influences on postoperative pain, potentially improving pain management protocols for aesthetic surgery patients.
Detailed description
INTRODUCTION Pain is an unpleasant experience associated with actual or potential tissue damage, involving sensory, emotional, cognitive, and social components (1). There are studies in the literature that examine the relationship between postoperative acute pain and psychological factors (2, 3). For example, studies in cancer patients undergoing reconstructive breast surgery have shown that depression, anxiety levels, and abnormal pain perception (pain catastrophizing) are associated with postoperative pain (4). Psychological factors that could influence pain in aesthetic surgeries may be more diverse. Self-esteem and personality types are among the psychological factors that could affect pain.
Self-esteem refers to an individual's beliefs and perceptions about themselves. It plays a significant role in shaping an individual's thoughts about their physical appearance. People with low self-esteem are generally dissatisfied with their appearance, which may lead them to seek aesthetic surgery as a way to improve their self-worth. Low self-esteem has been associated with an increased likelihood of undergoing aesthetic surgery (5). Furthermore, aesthetic surgeries have been linked to significant improvements in self-esteem. A systematic review conducted by Javo and colleagues (2019) showed that more than 70% of aesthetic surgery patients experienced significant increases in self-esteem (6).
Another factor that could be related to pain is personality traits. Studies have shown that personality traits are important predictors of postoperative pain and complications in aesthetic surgeries (7). Traits such as perfectionism, neuroticism, and anxiety have been associated with increased postoperative pain and poor surgical outcomes. Individuals with these traits may experience anxiety and fear before surgery, leading to a lower pain threshold and increased sensitivity to pain sensations.
Aesthetic surgery is a rapidly growing industry worldwide. The desire for physical recovery and maintaining a youthful appearance has led to an increase in demand for aesthetic surgeries. However, the psychological effects of these surgeries and their relationship with pain have not been fully investigated. The aim of our study is to examine the relationship between psychosocial factors, particularly self-esteem and personality types, and postoperative pain in patients undergoing aesthetic breast surgery. This study is expected to contribute to the literature on developing personalized pain management strategies for aesthetic surgery patients.
To investigate the relationship between self-esteem, personality types, other psychosocial factors, and postoperative pain in patients undergoing aesthetic breast surgery. To contribute to the literature on the development of personalized pain protocols for aesthetic surgery patients.
METHOD After obtaining ethical approval from the Koç University Committee on Human Research, with approval number [2023.305.IRB1.101], a prospective, observational cohort study will be conducted at VKV American Hospital. Patients scheduled for aesthetic breast surgery between January 2024 and January 2025 will be informed about the study and invited to participate. Participants eligible for inclusion in the study must be aged 18 years or older and have an American Society of Anesthesiologists (ASA) physical status classification of 1-3. Individuals will be excluded if they are under the age of 18, have an ASA status of 4, decline to participate, or have a history of anxiety disorders and/or psychological conditions.
The study will include three main phases: preoperative, intraoperative, and postoperative periods. The data collected from these periods will be used to evaluate perioperative outcomes, including pain management efficacy, recovery quality, and overall patient satisfaction.
- Preoperative Period: One week before surgery, during the initial surgical consultation, participants will provide informed consent. Demographic data and several validated assessment scales will be collected, including the Perceived Socioeconomic Status Scale (8), Ten-Item Personality Inventory (9), Pain Catastrophizing Scale (10), Hospital Anxiety and Depression Scale (11), Rosenberg Self-Esteem Scale (12), Quality of Recovery-15 (QoR-15) questionnaire (13), and the Visual Analog Scale (VAS) for pain (14).
- Intraoperative Period: All surgical procedures will follow the standard general anesthesia protocol of the hospital. General anesthesia induction will involve propofol (1-2 mg/kg), fentanyl (1 mcg/kg), and rocuronium (0.6 mg/kg) for endotracheal intubation. Anesthesia maintenance will be performed with desflurane (4-6%) and remifentanil (0.1 mcg/kg/min), with adjustments as needed based on blood pressure and heart rate. Post-induction, dexamethasone (4 mg) will be administered for anti-inflammatory effects. To support postoperative pain management, tramadol (1 mg/kg), ibuprofen (400 mg), and paracetamol (1 g) will be administered before the end of the procedure. Ondansetron (4 mg) will be used for nausea prophylaxis. All intraoperative medications and dosages will be recorded without intervention.
- Postoperative Period:
In the recovery room, pain scores will be recorded at 0, 30, and 60 minutes postoperatively by blinded nurses. Analgesic interventions will follow the hospital's standard protocol: patients with VAS scores between 3 and 7 will receive 25 mcg of fentanyl, while those with scores above 7 will receive 50 mcg. The total fentanyl dosage and any side effects, such as nausea, respiratory difficulty, or shivering, will be documented.
All patients will receive standard multimodal analgesia during the ward stay, including paracetamol (1 g, three times daily) and ibuprofen (400 mg, twice daily). Patient-controlled analgesia (PCA) devices will administer tramadol (10 mg IV per patient request, without continuous infusion). Data on VAS scores at 6 and 24 hours postoperatively, as well as the total tramadol dosage administered via PCA, will be recorded. Additionally, participants' satisfaction with pain management will be assessed using the Quality of Recovery-15 scale at 24 hours postoperatively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients scheduled for aesthetic breast surgery | – | Other: Preoperative Interventions, Other: Intraoperative Interventions, Other: Postoperative InterventionsThis group includes patients undergoing aesthetic breast surgery between January 2024 and January 2025 who are assessed preoperatively, intraoperatively, and postoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for aesthetic breast surgery between January 2024 and January 2025 will be informed about the study and invited to participate.
Key inclusion criteria (2 listed)
- 18 years or older
- Have an American Society of Anesthesiologists (ASA) physical status classification of 1-3.
Key exclusion criteria (3 listed)
- under the age of 18,
- have an ASA status of 4,
- history of anxiety disorders and/or psychological conditions.
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 |
|---|---|---|
| Preoperative InterventionsDuring the initial surgical consultation, participants will provide informed consent. Demographic data and several validated assessment scales will be collected, including the Perceived Socioeconomic Status Scale (8), Ten-Item Personality Inventory (9), Pain Catastrophizing Scale (10), Hospital Anxiety and Depression Scale (11), Rosenberg Self-Esteem Scale (12), Quality of Recovery-15 (QoR-15) questionnaire (13), and the Visual Analog Scale (VAS) for pain (14). | Other | Patients scheduled for aesthetic breast surgery |
| Intraoperative InterventionsAll surgical procedures will follow the standard general anesthesia protocol of the hospital. General anesthesia induction will involve propofol (1-2 mg/kg), fentanyl (1 mcg/kg), and rocuronium (0.6 mg/kg) for endotracheal intubation. Anesthesia maintenance will be performed with desflurane (4-6%) and remifentanil (0.1 mcg/kg/min), with adjustments as needed based on blood pressure and heart rate. Post-induction, dexamethasone (4 mg) will be administered for anti-inflammatory effects. To support postoperative pain management, tramadol (1 mg/kg), ibuprofen (400 mg), and paracetamol (1 g) will be administered before the end of the procedure. Ondansetron (4 mg) will be used for nausea prophylaxis. All intraoperative medications and dosages will be recorded without intervention. | Other | Patients scheduled for aesthetic breast surgery |
| Postoperative InterventionsIn the recovery room, analgesic interventions will follow the hospital's standard protocol: patients with VAS scores between 3 and 7 will receive 25 mcg of fentanyl, while those with scores above 7 will receive 50 mcg. All patients will receive standard multimodal analgesia during the ward stay, including paracetamol (1 g, three times daily) and ibuprofen (400 mg, twice daily). Patient-controlled analgesia (PCA) devices will administer tramadol (10 mg IV per patient request, without continuous infusion). | Other | Patients scheduled for aesthetic breast surgery |
Primary outcome
Patient Satisfaction
Time frame: Preoperatively and 24 hours postoperatively.
Participants' satisfaction with pain management will be assessed using the Quality of Recovery-15 scale preoperatively and 24 hours postoperatively. The QoR-15 test scores responses on a scale where 10 represents "always," and 0 means "never." The test has a maximum possible score of 150 and a minimum of 0. QoR-15 scores are classified into the following categories: excellent (QoR-15 > 135), good (122 ≤ QoR-15 ≤ 135), moderate (90 ≤ QoR-15 ≤ 121), and poor (QoR-15 < 90).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- BackgroundÇuhadaroğlu, F. (1986). Adolesanlarda benlik saygısı. Yayınlanmamış uzmanlık tezi. Hacettepe Üniversitesi.
- Results publication: PubMed 8484338Miller MD, Ferris DG. Measurement of subjective phenomena in primary care research: the Visual Analogue Scale. Fam Pract Res J. 1993 Mar;13(1):15-24.
- Results publication: PubMed 36161615Kara U, Simsek F, Kamburoglu H, Ozhan MO, Alakus U, Ince ME, Eksert S, Ozkan G, Eskin MB, Senkal S. Linguistic validation of a widely used recovery score: quality of recovery-15 (QoR-15). Turk J Med Sci. 2022 Apr;52(2):427-435. doi: 10.55730/1300-0144.5330. Epub 2022 Apr 14.
- Results publication: PubMed 28425232Karakas Ugurlu G, Ugurlu M, Erten S, Can SS, Ulusoy Kaymak S, Caykoylu A. Effect of familial Mediterranean fever on sexual and reproductive health in women. Turk J Med Sci. 2017 Apr 18;47(2):463-469. doi: 10.3906/sag-1602-88.
- Results publicationAydemir, O. J. T. P. D. (1997). Hastane anksiyete ve depresyon olcegi Turkce formunun gecerlilik ve guvenilirligi. Turk Psikiyatri Derg., 8, 187-280.
- Results publicationAtak, H. (2013). On-Maddeli Kişilik Ölçeği'nin Türk Kültürü'ne Uyarlanması. Archives of Neuropsychiatry/Nöropsikiyatri Arşivi, 50(4).
- Results publication: PubMed 11129362Adler NE, Epel ES, Castellazzo G, Ickovics JR. Relationship of subjective and objective social status with psychological and physiological functioning: preliminary data in healthy white women. Health Psychol. 2000 Nov;19(6):586-92. doi: 10.1037//0278-6133.19.6.586.
- Results publication: PubMed 30476655Schreiber KL, Zinboonyahgoon N, Xu X, Spivey T, King T, Dominici L, Partridge A, Golshan M, Strichartz G, Edwards RR. Preoperative Psychosocial and Psychophysical Phenotypes as Predictors of Acute Pain Outcomes After Breast Surgery. J Pain. 2019 May;20(5):540-556. doi: 10.1016/j.jpain.2018.11.004. Epub 2018 Nov 23.
- Results publication: PubMed 35766540Kam O, Na S, La Sala M, Tejeda CI, Koola MM. The Psychological Benefits of Cosmetic Surgery. J Nerv Ment Dis. 2022 Jul 1;210(7):479-485. doi: 10.1097/NMD.0000000000001477.
- Results publication: PubMed 15083026Honigman RJ, Phillips KA, Castle DJ. A review of psychosocial outcomes for patients seeking cosmetic surgery. Plast Reconstr Surg. 2004 Apr 1;113(4):1229-37. doi: 10.1097/01.prs.0000110214.88868.ca.
- Results publication: PubMed 28713853Kulkarni AR, Pusic AL, Hamill JB, Kim HM, Qi J, Wilkins EG, Roth RS. Factors Associated with Acute Postoperative Pain Following Breast Reconstruction. JPRAS Open. 2017 Mar;11:1-13. doi: 10.1016/j.jpra.2016.08.005. Epub 2016 Sep 15.
- Results publication: PubMed 27551421Bradshaw P, Hariharan S, Chen D. Does preoperative psychological status of patients affect postoperative pain? A prospective study from the Caribbean. Br J Pain. 2016 May;10(2):108-15. doi: 10.1177/2049463716635680. Epub 2016 Mar 2.
- Individual participant dataSharing planned: Yes. All shared data will be de-identified to protect participant confidentiality, and access will be granted only to researchers who meet the necessary criteria and ethical standards for data use.
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Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Psychological Factors, run by V.K.V. American Hospital, Istanbul at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: Preoperatively and 24 hours postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06707818, which also lists 14 linked publications.
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 15 Jan 2026.