Gender-specific Preoperative Anxiety Level and Postoperative Opioid Requirement After ENT Surgery.

NCT ID: NCT05141591

Last Updated: 2025-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-11

Study Completion Date

2026-12-30

Brief Summary

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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.

Detailed Description

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Background Due to the frequency of surgeries, acute postsurgical pain (APSP) is a common clinical problem. In this study, the investigators will investigate pre-surgical psychological factors associated with the experience of APSP in ENT surgery.

The study will be designed to investigate the impact of gender-specific preoperative anxiety states, using the STOA, APAIS, PCS and VAS-A scoring systems, on postoperative opioid consumption after elective ENT surgery.

These findings may have important implications for developing more personalized strategies in acute postoperative pain therapy in selected patients.

Aim Study aim is to investigate the impact of the preoperative anxiety level, using the validated STOA questionnaire, 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.

The investigators hypothesize that a higher preoperative anxiety state, is a predictive factor of opioid requirement in the early postoperative period after ENT surgery.

Methods Surgery-related psychological factors like anxiety state will be assessed gender-specific, in patients scheduled for elective ENT surgery by validated questionnaires (STOA, APAIS, PCS and VAS-A), filled out by the patient the day before surgery and on the day of surgery, to investigate the correlation with the postoperative opioid consumption.

Conditions

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Anxiety Acute Post Operative Pain

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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ENT surgical patients

ASA physical status I-IV adult subjects, ≥ 18 years of age, scheduled for elective ENT surgeries in the Department of ENT at the Medical University of Vienna. On the day before elective ENT- surgery patients will be asked to complete self-administered questionnaires (STOA, APAIS, PCS) concerning their emotional and anxiety state. These questionnaires will be re-tested on the day of surgery and opioid consumption during the stay in the recovery room documented.

Anxiety level assessment

Intervention Type OTHER

To investigate the impact of psychological variables e.g. pre-surgical anxiety on postoperative opioid consumption and pain level, the investigators will perform the STOA, APAIS, PCS and the VAS-A anxiety questionnaires before surgery.

Interventions

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Anxiety level assessment

To investigate the impact of psychological variables e.g. pre-surgical anxiety on postoperative opioid consumption and pain level, the investigators will perform the STOA, APAIS, PCS and the VAS-A anxiety questionnaires before surgery.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Marita Windpassinger M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical University Vienna

Vienna, Vienna, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Marita Windpassinger, MD

Role: CONTACT

+43 1 40400 41020

Olga Plattner, MD

Role: CONTACT

+43 1 40400 41020

Facility Contacts

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Marita Windpassinger, MD

Role: primary

+43140400 ext. 41020

Olga Plattner, MD

Role: backup

+43140400 ext. 41020

Other Identifiers

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2006/2021

Identifier Type: -

Identifier Source: org_study_id

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