Psychosocial Factors and Postoperative Pain in Aesthetic Breast Surgery

NCT06707818 | Completed

• 1 other identifier: PostopPainAndPsychology
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain; Psychological Factors; Breast Surgery; Aesthetic Surgery; Anesthesia, General; Quality of Recovery (QoR-15); Patient Satisfaction; Pain Management

Keywords

Postoperative pain; Aesthetic breast surgery; psychosocial factors; pain management

Outcome Measures

Primary Outcomes (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).

  Preoperatively and 24 hours postoperatively.

Study Arms (1)

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.

Other: Preoperative Interventions; Other: Intraoperative Interventions; Other: Postoperative Interventions

Interventions

Preoperative Interventions OTHER

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).

Patients scheduled for aesthetic breast surgery

Intraoperative Interventions OTHER

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.

Patients scheduled for aesthetic breast surgery

Postoperative Interventions OTHER

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).

Patients scheduled for aesthetic breast surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for aesthetic breast surgery between January 2024 and January 2025 will be informed about the study and invited to participate.

You may qualify if:

• years or older
• Have an American Society of Anesthesiologists (ASA) physical status classification of 1-3.

You may not qualify if:

• under the age of 18,
• have an ASA status of 4,
• history of anxiety disorders and/or psychological conditions.

Sponsors & Collaborators

• V.K.V. American Hospital, Istanbul: lead

Study Sites (1)

VKV American Hospital

Istanbul, 34365, Turkey (Türkiye)

Location

Related Publications (14)

• Çuhadaroğlu, F. (1986). Adolesanlarda benlik saygısı. Yayınlanmamış uzmanlık tezi. Hacettepe Üniversitesi.

  BACKGROUND

• 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.

  PMID: 8484338 RESULT

• 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.

  PMID: 36161615 RESULT

• 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.

  PMID: 28425232 RESULT

• Aydemir, O. J. T. P. D. (1997). Hastane anksiyete ve depresyon olcegi Turkce formunun gecerlilik ve guvenilirligi. Turk Psikiyatri Derg., 8, 187-280.

  RESULT

• Atak, H. (2013). On-Maddeli Kişilik Ölçeği'nin Türk Kültürü'ne Uyarlanması. Archives of Neuropsychiatry/Nöropsikiyatri Arşivi, 50(4).

  RESULT

• 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.

  PMID: 11129362 RESULT

• 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.

  PMID: 30476655 RESULT

• 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.

  PMID: 35766540 RESULT

• 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.

  PMID: 15083026 RESULT

• 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.

  PMID: 28713853 RESULT

• 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.

  PMID: 27551421 RESULT

• 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.

  PMID: 35427271 RESULT

• 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.

  PMID: 27200490 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Patient Satisfaction; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: November 27, 2024
• Study Start: April 15, 2024
• Primary Completion: December 15, 2025
• Study Completion: January 10, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The start date for IPD sharing will be after the completion of the study and the publication of the main study results, approximately June 2025. End Date for IPD Sharing: IPD will be available for sharing for a period of 5 years following the publication of the study results, until June 2030. During this period, researchers who meet the criteria for access will be able to request the de-identified data for secondary analyses.

Locations

TU (1)