Can special glasses called prismatic loupes improve surgeons' work and help them feel less uncomfortable while working in the operating room?
| ISRCTN | ISRCTN34264292 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34264292 |
- Submission date
- 22/08/2023
- Registration date
- 23/08/2023
- Last edited
- 23/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Neck pain is commonly reported among surgeons. The pain is often related to the awkward neck postures during operations. Prismatic loupes that infract light have been shown, in simulated tasks within a short training period, to improve neck posture for surgeons. However, little has been studied regarding the effects of prismatic loupes on surgeons’ physical workload and discomfort in actual operations.
The primary aim of this study was to evaluate the effects of using prismatic loupes, when compared to conventional non-prismatic loupes, on surgeons intraoperative physical workload and musculoskeletal discomfort. The secondary aim was to evaluate the visual qualities and usability of prismatic loupes during actual operations.
Who can participate?
Experienced surgeons (experience of surgery>2 years) from an academic university hospital who actively perform open surgeries and have joined a test using prismatic loupes in a clinical training centre at the time of recruitment can volunteer to participate.
What does the study involve?
In this study, we evaluated surgeons' intraoperative physical workload and musculoskeletal discomfort using the prismatic loupes and non-prismatic lopes during real surgeries. Participants performed two similar operations on one day in a random order using prismatic and non-prismatic conventional loupes. Physical workload was evaluated with two set of sensors: the muscular activity of the upper trapezius and neck extensors using EMG electrodes, and the postures and movements of the head, trunk, and upper arms using IMU sensors. Questionnaires on body-part discomfort, perceived workload, visual qualities, and usability of the loupes were filled in.
What are the possible benefits and risks of participating?
The major possible benefits were hypothesised to reduce the physical workload and the risk of developing neck-shoulder pain are reduced for surgeons by using these prismatic loupes. There is no health risk of participating in the study. The particapants are free to end their participation at any time.
Where is the study run from?
Karolinska University Hospital at Solna, Stockholm, Sweden
When is the study starting and how long is it expected to run for?
October 2019 to March 2023
Who is funding the study?
Afa Insurance (AFA) (Sweden)
Who is the main contact?
Prof. Mikael Forsman, miforsm@kth.se
Contact information
Principal Investigator
Hälsovägen 11C
KTH Kungliga Tekniska Högskolan
Stockholm
141 57
Sweden
 ORCID ID |
0000-0001-5777-4232 |
|---|---|
| Phone | +46 704910196 |
| miforsm@kth.se |
Scientific
Solnavägen 4, plan 10
Karolinska Institutet
Stockholm
113 65
Sweden
| ORCID ID |
0000-0001-7285-824X |
|---|---|
| Phone | +46764250005 |
| liyun.yang@ki.se |
Scientific
Hälsovägen 11C
KTH Kungliga Tekniska Högskolan
Stockholm
14157
Sweden
| Phone | +46 704910196 |
|---|---|
| miforsm@kth.se |
Public
Solnavägen 4, plan 10
Karolinska Institutet
Stockholm
113 65
Sweden
| Phone | +46 764250005 |
|---|---|
| liyun.yang@ki.se |
Study information
| Study design | Randomized cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Evaluation of prismatic loupes on surgeons' intraoperative physical workload and musculoskeletal discomfort compared to conventional loupes - A crossover randomized controlled trial |
| Study acronym | PrismSurg2 |
| Study objectives | 1. Using prismatic loupes reduce surgeons' intraoperative physical workload compared to conventional loupes 2. Using prismatic loupes reduce surgeons' musculoskeletal discomfort after surgery compared to conventional loupes |
| Ethics approval(s) |
Approved 16/02/2020, Swedish Ethical Review Authority (Etikprövningsmyndigheten Box 2110, Uppsala, 750 02, Sweden; +46 10-4750800; registrator@etikprovning.se), ref: 2020-02161 |
| Health condition(s) or problem(s) studied | Work-related musculoskeletal disorders |
| Intervention | Each participating surgeon conducted two comparable procedures in the measurement day, using prismatic loupes and conventional loupes, interspersed by a standard break as per the hospital's routine schedule. The type of surgical loupes used in the first operation, whether conventional or prismatic, was randomly assigned, and then alternated for the subsequent procedure. The assignment of order is calculated in Excel with a randomization function. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Two types of surgical prismatic loupes from Optergo AB, Mölnlycke, Sweden and HOYA Technosurgical Corporation, Tokyo, Japan. |
| Primary outcome measure | Physical workload was measured using two sets of sensors during the whole surgeries. First, bipolar surface EMG was recorded bilaterally from the neck extensors and upper trapezius. Second, upper arms, trunk, and head postures and movements were recoded using inertial measurement units (IMUs). |
| Secondary outcome measures | 1. Perceived body-part discomforts of neck, both shoulders, upper and lower back, and fatigue were measured using Borg CR-10 scale before and after each surgery. 2. Perceived visual qualities of the loupes were measured using 5-point Likert-type scale scoring from very bad to very good after each surgery. 3. Potential physical symptoms related to loupes usage including double vision, headache and nausea were assessed on a 4-point scale scoring from severe to no symptoms after each surgery. 4. Self-rated surgical workload was assessed using a modified NASA-TLX scale, including dimensions of mental and physical demand, temporal demand, distractions, frustrations, task complexity, situational stress, and performance after each surgery. 5. The usability of the prismatic loupes, including easiness to use and intention for frequent future use, was measured using a 5-point Likert scale after all surgeries. 6. Subjective evaluations and experiences of the loupes were measured using semi-structured interview after all surgeries. |
| Overall study start date | 01/10/2019 |
| Completion date | 17/03/2023 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 15 |
| Key inclusion criteria | 1. Currently actively working as surgeons. 2. Work experience as surgeons >= 2 years. 3. Work actively with open surgeries in vascular surgery or in otorhinolaryngology (endocrine surgery). |
| Key exclusion criteria | Surgeons who experienced severe physical symptoms when using the prismatic loupes. |
| Date of first enrolment | 22/03/2022 |
| Date of final enrolment | 17/03/2023 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Solna
Stockholm
17176
Sweden
Sponsor information
University/education
Solnavägen 4, plan 10
Stockholm
113 65
Sweden
| Phone | +46764250005 |
|---|---|
| compliance@ki.se | |
| Website | https://ki.se |
"ROR" |
https://ror.org/056d84691 |
University/education
Hälsovägen 11C
Stockholm
14157
Sweden
| Phone | +46 704910196 |
|---|---|
| researchdata@kth.se | |
| Website | http://www.kth.se/en |
|
"ROR" |
https://ror.org/026vcq606 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- AFA Insurance
- Location
- Sweden
Results and Publications
| Intention to publish date | 17/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Prof Mikael Forsman, miforsm@kth.se |
Editorial Notes
22/08/2023: Trial's existence confirmed by Swedish Ethical Review Authority.
