Anxiety Clinical Trial
Official title:
The Impact of Gender-specific Preoperative Anxiety Level on Postoperative Opioid Requirement After ENT Surgery.
The study will be designed to investigate the impact of the preoperative anxiety level on postoperative opioid requirement during the PACU stay, in order to improve postoperative pain treatment in the long term after ENT surgery. The present study can contribute to improve postoperative pain management in patients in the field of ENT surgery, as new influencing parameters and risk factors may be discovered.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 30, 2024 |
Est. primary completion date | December 29, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - American Society of Anesthesiology (ASA) physical status I-IV - able to read and understand the information sheet and to sign the consent form - being scheduled for elective ENT surgery under general anesthesia - written informed consent - age=18 years Exclusion Criteria: - difficulty to understand study procedure, pain scoring system or questionnaires - surgical procedure warranting elective postoperative ventilation |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Anxiety scores-APAIS | APAIS-Amsterdam Preoperative Anxiety and Information Scale Total range 6 to 30, a higher value reflects a higher anxiety as well as higher information requirement. | on the 1 day before surgery and on the 1 day of surgery | |
Other | Postoperative Pain Score-VAS | NRS score: evaluated at arrival and discharge from the PACU time to first analgesic (non-opioid, opioid) supplementation postoperatively in the PACU | during the stay in the recovery room assessed up to 2 hours | |
Other | Anxiety scores-PCS | PCS-Pain catastrophizing scale The higher the total score, the greater the individual risk of catastrophic pain. The PCS score ranges from 0 to 52 points. | on the 1 day before surgery and on the 1 day of surgery | |
Other | VAS-A. anxiety score | The VAS-A scale is comprised of a horizontal line 100mm long with the indication "no anxiety" to the left and "worst possible anxiety" to the right. The higher the total score, the greater the individual anxiety level. | preoperative on the 1 day of surgery, immediately postoperative in the PACU | |
Primary | Opioid consumption | cumulative opioid consumption within PACU stay | during the stay in the recovery room assessed up to 2 hours | |
Secondary | Postoperative Pain Score-VAS-PACU | mean pain level on an 11-point verbal Likert response score recorded at 30-minute intervals during the PACU stay, ranging between 0 and 10, with higher levels indicating higher pain intensity | during the stay in the recovery room assessed up to 2 hours |
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