NCT07568158

Brief Summary

The goal of this observational study is to measure the cognitive load (mental effort) of anesthesia nurses during real surgical procedures at Hospital Clínic de Barcelona, Spain. The main questions it aims to answer are:

  • Does cognitive load vary across the three phases of anesthetic care (induction, maintenance, and emergence/recovery)?
  • Is cognitive load higher during general anesthesia than during spinal anesthesia with sedation?
  • How do surgical specialty and patient complexity relate to cognitive load?
  • How does monitor alarm perception relate to cognitive load during surgery? Participants (anesthesia nurses) will complete the NASA Task Load Index (NASA-TLX) questionnaire - a validated 6-item tool measuring mental effort - three times per surgical case: after induction or spinal block, during maintenance, and after patient awakening or sedation reversal. They will also answer 4 brief questions about alarm management at the end of each case. No changes are made to clinical care. Participation adds approximately 11 minutes per surgical case.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

April 28, 2026

Last Update Submit

April 28, 2026

Conditions

Keywords

NASA-TLXAnesthesia NursingPerioperative NursingMental WorkloadIntraoperativePatient SafetyMonitor AlarmsOperating Room

Outcome Measures

Primary Outcomes (1)

  • Global Raw NASA-TLX Score

    Subjective cognitive load measured using the Raw NASA Task Load Index (NASA-TLX), calculated as the arithmetic mean of six subscales (mental demand, physical demand, temporal demand, performance, effort, and frustration), each rated on a 0-100 scale. Administered three times per surgical case: after induction or spinal block (T1), during maintenance (T2), and after extubation or end of sedation (T3). Study duration: approximately 8 months.

    At three time points per surgical case: T1 (5 minutes post-induction/spinal block), T2 (during maintenance, before surgical closure), and T3 (5 minutes after extubation/end of sedation ).

Secondary Outcomes (2)

  • NASA-TLX Subscale Scores

    At T1, T2, and T3 per surgical case over approximately 8 months.

  • Monitor Alarm Perception Visual Analog Scale (VAS)

    Once per surgical case, after T3, over approximately 8 months.

Other Outcomes (1)

  • Alarm Management Behavior and Attention Interference During Intraoperative Care.

    Once per surgical case, after T3, over approximately 8 months.

Study Arms (2)

General Anesthesia (GA)

Anesthesia nurses managing surgical cases under general anesthesia (endotracheal intubation or laryngeal mask airway). Cognitive load measured at three phases: post-induction (T1), maintenance (T2), and post-extubation (T3).

Other: NASA Task Load Index (NASA-TLX)

Spinal Anesthesia with Sedation

Anesthesia nurses managing surgical cases under spinal anesthesia combined with intravenous sedation. Cognitive load measured at three phases: post-spinal block and sedation initiation (T1), maintenance (T2), and end of sedation (T3).

Other: NASA Task Load Index (NASA-TLX)

Interventions

The Raw NASA Task Load Index (NASA-TLX) is a validated self-report questionnaire measuring subjective cognitive load across six dimensions: mental demand, physical demand, temporal demand, performance, effort, and frustration (scale 0-100). Administered three times per surgical case (T1, T2, T3) by the participating anesthesia nurse. Additionally, four questions about monitor alarm perception and management are completed after T3.

General Anesthesia (GA)Spinal Anesthesia with Sedation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Registered nurse anesthetists actively working at Hospital Clínic de Barcelona, a university tertiary care hospital, assigned to the following operating rooms: main surgical block, ambulatory surgery unit (CMA), interventional radiology suite (RIO), DIVAS intraoperative radiotherapy unit, and transplant operating room.

You may qualify if:

  • Registered nurse anesthetist actively working at Hospital Clínic de Barcelona.
  • Minimum 3 months in the current anesthesia nursing position.
  • Voluntary participation with signed informed consent.
  • Scheduled surgery (including deferred urgent surgery) or solid organ transplantation.
  • General anesthesia (endotracheal intubation or laryngeal mask airway) or spinal anesthesia with sedation.
  • Minimum duration of 30 minutes.

You may not qualify if:

  • Relief or rotating nurses without specific anesthesia training.
  • Nurses in initial training period (less than 3 months in position).
  • Refusal to participate or withdrawal of informed consent.
  • Spinal anesthesia without sedation.
  • Exclusive regional anesthesia without sedation.
  • Sedation alone without regional technique.
  • Duration less than 30 minutes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Related Publications (13)

  • The Joint Commission; Medical device alarm safety in hospitals; Sentinel Event Alert; 2013; (50)

    BACKGROUND
  • ECRI Institute; Top 10 Health Technology Hazards for 2022; ECRI Institute; 2021

    BACKGROUND
  • Hart SG, Staveland LE; Development of NASA-TLX (Task Load Index): results of empirical and theoretical research; Advances in Psychology; 1988; 52; 139-183

    BACKGROUND
  • Wickens CD; Multiple resources and mental workload; Hum Factors; 2008; 50(3); 449-455

    BACKGROUND
  • Sweller J; Cognitive load during problem solving: effects on learning; Cognitive Science; 1988; 12(2); 257-285

    BACKGROUND
  • Carayon P, Gurses AP; A human factors engineering conceptual framework of nursing workload and patient safety in intensive care units; Intensive Crit Care Nurs; 2005; 21(5); 284-301

    BACKGROUND
  • Reason J; Human error: models and management; BMJ; 2000; 320(7237); 768-770

    BACKGROUND
  • Wunderlich CA, Barnsteiner JH, Minnick A; Development of the Clinical Alarm Fatigue Questionnaire (CAFQa); J Nurs Scholarsh; 2021; 53(6); 681-690

    BACKGROUND
  • Cvach M; Monitor alarm fatigue: an integrative review; Biomed Instrum Technol; 2012; 46(4); 268-277

    BACKGROUND
  • Kennedy-Metz LR, Lehane CM, Yule S, Dias RD, Zenati MA; Measuring cognitive load in the cardiac operating room; J Thorac Cardiovasc Surg; 2020; 160(6); 1621-1630

    BACKGROUND
  • Piquilloud L, Tassaux D, Bialais E, Lambermont B, Roeseler J, Sottiaux T, Demoule A, Jolliet P; The work of breathing influences the cognitive load of nurses and physiotherapists during non-invasive ventilation assistance of patients with acute respiratory failure; Intensive Care Med; 2020; 46(5); 983-991

    BACKGROUND
  • Olin K, Göras C, Nilsson U, Unbeck M, Ehrenberg A, Pukk-Härenstam K, Florin J; Mapping registered nurse anaesthetists' intraoperative work: tasks, multitasking, interruptions and their causes, and interactions: a prospective observational study; BMJ Open; 2022; 12(1); e052283

    BACKGROUND
  • Göras C, Olin K, Unbeck M, Ehrenberg A, Pukk-Härenstam K, Nilsson U; Tasks, multitasking and interruptions among the surgical team in an operating room: a prospective observational study; BMJ Open; 2019; 9(5); e024763

    BACKGROUND

Related Links

MeSH Terms

Conditions

Alert Fatigue, Health Personnel

Condition Hierarchy (Ancestors)

Mental FatigueFatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Victor Caro-Frechilla, RN, MSc

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Victor Caro-Frechilla, RN, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
8 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered Nurse Anesthetist

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 5, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Individual participant data (IPD) to be shared includes the anonymized case-level dataset containing: NASA-TLX subscale scores (T1, T2, T3), surgical case characteristics (anesthetic technique, surgical specialty, ASA, duration), and exploratory alarm management variables (VAS, P1, P2, P3). Participant-level data (experience, training) will be included in anonymized form. No directly identifiable information will be shared.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
IPD and supporting documents will be available starting 6 months after publication of the primary results article (estimated 2027-2028) and will remain available for 5 years.
Access Criteria
IPD will be available upon reasonable request to the principal investigator (vcaro@clinic.cat). Requestors must provide: (1) a brief description of the proposed use, (2) institutional affiliation, and (3) agreement to data use conditions. Data will be shared as anonymized datasets in CSV format. No individual participant can be identified from the shared data.

Locations