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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Turkey (Türkiye)1 site
  • VKV American Hospital

    Istanbul, 34365

Other trials in Turkey (Türkiye)

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.

  1. 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).
  2. 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.
  3. 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.

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 groups in NCT06707818
Study groupRoleWhat they receive
Patients scheduled for aesthetic breast surgeryThis 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.

  1. 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.

  1. First posted27 Nov 2024
  2. Study start15 Apr 2024
  3. Primary completion15 Dec 2025
  4. Study completion10 Jan 2026

Resources

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
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 8484338
  • Kara 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 36161615
  • Karakas 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 28425232
  • Aydemir, 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 11129362
  • Schreiber 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 30476655
  • Kam 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 35766540
  • Honigman 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 15083026
  • Kulkarni 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 28713853
  • Bradshaw 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 27551421
  • Aglio 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 35427271
  • Williams 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

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.

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