Clinical trial NCT06707818: Psychosocial Factors and Postoperative Pain in Aesthetic Breast Surgery
Official title: Psychosocial Factors and Postoperative Pain in Aesthetic Breast Surgery: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: V.K.V. American Hospital, Istanbul
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Patient Satisfaction
timeFrame: Preoperatively and 24 hours postoperatively.
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: VKV American Hospital
Study officials:
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