Workplace StressENERGYNCT06951360
Workload Evaluation (Via NASA Task Load Index) of Robotic Assisted and Laparoscopic Surgery
An observational study of Workplace Stress, run by Otto-von-Guericke University Magdeburg at 1 site in Germany.
Trial summary
workload evaluation (via NASA Task Load Index) of robotic- assisted and laparoscopic surgery Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Workplace Stress
- What is being tested?
- ENERGY questionnaire
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 15 May 2022to Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: * involved medical stuff (surgeons, OR nurses, further professions) * patients undergoing laparoscopic and robotic procedures fulfilling the inclusion criterias
Who may be able to join
- robotic and laparoscopic procedures
Who cannot join
- decline of participation (patients, medical stuff)
- paparoscopic appendectomies, laparoscopic cholecystectomies
Trial locations and contacts
1 site in 1 country.
Germany1 site
Otto-von-Guericke University Magdeburg
Magdeburg, Saxony-Anhalt, 39120
About this study
Official title: ENERGY Study - Workload Evaluation (Via NASA Task Load Index) of Robotic Assisted and Laparoscopic Surgery
workload evaluation (via NASA Task Load Index) of robotic- assisted and laparoscopic surgery
Read the detailed description
evaluation of individual and overall workload during robotic visceral surgeries using NASA Task Load Index and one additional question referring to difficulty level of the operation in comparison with laparoscopic procedures
- Conditions
- Workplace Stress
- Being tested
- ENERGY questionnaire
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENERGY questionnaireProcedure or surgery
Questionnaire including NASA Task Load Index, difficulty level of operation, patient and operation factors
| Study group | Role | What they receive |
|---|---|---|
| robotic procedures | residents, specialists and experts performing robotic visceral surgeries Receives: Procedure: ENERGY questionnaire | |
| laparoscopic procedures | residents, specialists and experts performing laparoscopic visceral surgeries Receives: Procedure: ENERGY questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall workload
NASA Task Load overall workload
Measured: 5 years
surgical expertise
surgical experience counting numbers of open, laparoscopic, robotic procedures and years of surgical practice
Measured: 5 years
Secondary outcomes (4)
NASA Task Load Index subscales
mental, physical, temporal demand, performance, effort, frustration
Measured: 5 years
procedure's difficulty level
additional question to evaluate the variation of difficulty of the performed procedure to expected level of difficulty; 3 levels
Measured: 5 years
patient factors
age, sex, BMI, preexisting illnesses/diseases using CCI (Charlson Comorbidity Index), previous operations, ASA
Measured: 5 years
procedure characteristics
indication, performed operation, intraoperative complications using Clavien-Dindo classification, operation duration, blood loss
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start15 May 2022
- Primary completionApr 2026 (estimated)
- Study completionSep 2026 (estimated)
Why it stopped: No multicenter recriutiment feasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Workplace StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otto-von-Guericke University Magdeburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Stockheim, Otto-von-Guericke University Magdeburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951360
- Sponsor's protocol ID
- ENERGY study
- Acronym
- ENERGY
- Status last verified
- Apr 2025
- First submitted
- 22 May 2022
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Quan H, Li B, Couris CM, Fushimi K, Graham P, Hider P, Januel JM, Sundararajan V. Updating and validating the Charlson comorbidity index and score for risk adjustment in hospital discharge abstracts using data from 6 countries. Am J Epidemiol. 2011 Mar 15;173(6):676-82. doi: 10.1093/aje/kwq433. Epub 2011 Feb 17.
PubMed 21330339Lowndes BR, Forsyth KL, Blocker RC, Dean PG, Truty MJ, Heller SF, Blackmon S, Hallbeck MS, Nelson H. NASA-TLX Assessment of Surgeon Workload Variation Across Specialties. Ann Surg. 2020 Apr;271(4):686-692. doi: 10.1097/SLA.0000000000003058.
PubMed 30247331
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENERGY Study - Workload Evaluation (Via NASA Task Load Index) of Robotic Assisted and Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT06951360
- Acronym / sponsor ID
- ENERGY / ENERGY study
- Conditions
- Workplace Stress
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No multicenter recriutiment feasible
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Otto-von-Guericke University MagdeburgUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
workload evaluation (via NASA Task Load Index) of robotic- assisted and laparoscopic surgery
Detailed description
evaluation of individual and overall workload during robotic visceral surgeries using NASA Task Load Index and one additional question referring to difficulty level of the operation in comparison with laparoscopic procedures
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| robotic procedures | – | Procedure: ENERGY questionnaireresidents, specialists and experts performing robotic visceral surgeries |
| laparoscopic procedures | – | Procedure: ENERGY questionnaireresidents, specialists and experts performing laparoscopic visceral surgeries |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- * involved medical stuff (surgeons, OR nurses, further professions) * patients undergoing laparoscopic and robotic procedures fulfilling the inclusion criterias
Key inclusion criteria (1 listed)
- robotic and laparoscopic procedures
Key exclusion criteria (2 listed)
- decline of participation (patients, medical stuff)
- paparoscopic appendectomies, laparoscopic cholecystectomies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENERGY questionnaireQuestionnaire including NASA Task Load Index, difficulty level of operation, patient and operation factors | Procedure or surgery | laparoscopic procedures, robotic procedures |
Primary outcome
Overall workload
Time frame: 5 years
NASA Task Load overall workload
surgical expertise
Time frame: 5 years
surgical experience counting numbers of open, laparoscopic, robotic procedures and years of surgical practice
4 secondary outcomes
NASA Task Load Index subscales
Time frame: 5 years
procedure's difficulty level
Time frame: 5 years
patient factors
Time frame: 5 years
procedure characteristics
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Results publication: PubMed 21330339Quan H, Li B, Couris CM, Fushimi K, Graham P, Hider P, Januel JM, Sundararajan V. Updating and validating the Charlson comorbidity index and score for risk adjustment in hospital discharge abstracts using data from 6 countries. Am J Epidemiol. 2011 Mar 15;173(6):676-82. doi: 10.1093/aje/kwq433. Epub 2011 Feb 17.
- Results publication: PubMed 30247331Lowndes BR, Forsyth KL, Blocker RC, Dean PG, Truty MJ, Heller SF, Blackmon S, Hallbeck MS, Nelson H. NASA-TLX Assessment of Surgeon Workload Variation Across Specialties. Ann Surg. 2020 Apr;271(4):686-692. doi: 10.1097/SLA.0000000000003058.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Workplace Stress, run by Otto-von-Guericke University Magdeburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall workload (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06951360, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.