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Reducing Physical Workload Among Assistant Nurses Through Ergonomic Work Technique Training With or Without Biofeedback

Reducing Physical Workload Among Assistant Nurses Through Ergonomic Work Technique Training With or Without Biofeedback: Study Protocol for a Multicentre Randomised Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07805629
Acronym
HUMLA
Enrollment
60
Registered
2026-09-04
Start date
2027-01-18
Completion date
2028-12-31
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Work-Related Musculoskeletal Disorders

Keywords

musculoskeletal disorders, nursing assistants, patient transfers, ergonomics, biofeedback, occupational health, workplace intervention, randomised controlled trial

Brief summary

Assistant nurses often develop work-related pain in the back, neck and shoulders because their work involves frequent patient handling and movement. Training in safe patient handling may help reduce pain and injury risk, and biofeedback may further support better work techniques during everyday care work. This study will test whether workplace-based training in patient handling can reduce musculoskeletal problems among assistant nurses. It will also examine whether adding six weeks of self-managed biofeedback-supported work technique training gives extra benefits compared with patient handling training alone. The study will include 60 assistant nurses with musculoskeletal symptoms, who will be randomly assigned to one of the two training groups. Data will be collected through interviews, physical assessments, questionnaires at baseline, six weeks and six months, and weekly SMS monitoring. Interviews with assistant nurses and managers will also explore how the intervention works in practice, how safe patient handling can be promoted, and what organisational factors support safer working methods.

Detailed description

Introduction: Assistant nurses (AN) are at high risk of work-related musculoskeletal disorders (WMSD) affecting the back and neck/shoulder region. Patient handling and movement (PHM) competence and safe working methods may reduce symptoms and injury risk. Biofeedback may further support the acquisition of more sustainable work techniques. However, early workplace-based interventions using biofeedback during ordinary care work remain insufficiently explored. The aim of the study is to evaluate whether early workplace-based interventions focused on PHM competence can reduce WMSD among AN. Another aim is to examine whether self-administered work technique training supported by biofeedback provides additional benefits beyond PHM competence training alone. Furthermore, we aim to explore managers' experiences of promoting workplace safety within nursing assistants' caregiving practice. Methods and analysis: This is a multicentre, prospective, longitudinal, two-arm randomised controlled trial in which 60 AN with WMSD will be included. After providing written informed consent, participants will be randomised to PHM training alone or PHM training plus six weeks of self-administered biofeedback-supported work technique training. Data will be collected through clinical interviews, functional screening, and physical measures. Questionnaires will be completed at baseline, six weeks and six months. Weekly SMS-based monitoring will be conducted throughout the intervention period. Semi-structured interviews with AN and managers will explore experiences of the intervention, feasibility, implementation and organisational conditions for safe PHM. Quantitative data will be analysed using parametric or non-parametric methods, as appropriate, and interview data using inductive qualitative content analysis. Ethics and dissemination: Ethical approval was obtained from the Swedish Ethical Review Authority (2027-4422-01). All participants will provide written informed consent before participation. Data will be handled confidentially, stored securely and reported in non-identifiable form in accordance with the Declaration of Helsinki and the General Data Protection Regulation. Findings will be disseminated to healthcare, stakeholders, and students, and through scientific publications and presentations. Following participant approval, managers will receive an information letter describing the study and its requirements. Because participation will take place during working hours, approval from the participant's immediate manager is required. Managers of participating AN will also be invited to participate after providing written informed consent; the number of managers is not predetermined, as more than one nursing assistant may be recruited from each workplace. Each participant's manager will be provided with information regarding the study design and will receive educational material focused on ergonomics and PHM competence. Both participants and their managers will have access to project support and may contact the research team with questions throughout the study period.

Interventions

OTHERGroup A. Patient handling and movement training

Both groups: Participants in Groups A and B will receive individualised ergonomic advice tailored to their work situation and needs. During the first weeks, they will complete a digital educational programme delivered through the county council of Östergötland's educational platform and receive a five-step checklist for safe patient handling and movement (PHM), based on Safe Patient Handling - A Research-Based Guide for an Improved Work Environment. The programme includes theoretical and practical PHM training, with emphasis on risk assessment, safe patient transfers and other physically demanding work tasks. Practical instruction will also be provided in the participants' own workplaces.

OTHERGroup B: Patient handling and movement training plus biofeedback

Biofeedback-supported work technique training (Group B): Participants in Group B will additionally receive six weeks of self-administered work technique training supported by biofeedback (Wergonic AB, Tullinge, Sweden). Wearable inertial measurement unit sensors attached to the trunk and upper arm will monitor working postures during routine care work, particularly movements involving the back and neck/shoulder region (34, 35) (Figure 2). When unfavourable postures are detected, the system provides gentle vibrotactile feedback, which increases with less favourable postures and stops when a more ergonomic posture is adopted. After instruction, participants will use the system independently during normal work to practise less physically demanding work techniques. They will complete at least ten sessions of a minimum of 20 minutes over six weeks, with the option to train more frequently or for longer periods.

Sponsors

Linkoeping University
Lead SponsorOTHER_GOV
Region Östergötland
CollaboratorOTHER
Department of Health, Medicin and Caring Science, Linköping University
CollaboratorUNKNOWN
Region Jönköping County
CollaboratorOTHER_GOV
AFA försäkring
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

A joint reference group comprising representatives from trade unions, employees and employers has been established to support the planning, implementation and interpretation of the project.

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* Female assistant nurses (AN) * Employed in/ work in hospital inpatient care or residential care settings * Employment in south-east Sweden within the counties of Östergötland and Jönköping * Have at least one year of work experience as AN * Permanent employmentReport musculoskeletal symptoms in the neck/shoulder region and/or back; * Have average pain intensity of at least 3/10 on the NRS during the preceding week

Exclusion criteria

* Currently on sick leave; * Are receiving other ongoing treatment for their musculoskeletal condition * Have a disorder considered unrelated to their work

Design outcomes

Primary

MeasureTime frameDescription
Pain intensityBaseline, 6-week, 6-monthPain: Overall work-related musculoskeletal disorders current pain intensity in the back/neck/shoulder will be measured using the Numeric Rating Scale (NRS 0-10, higher levels indicate more severe pain). One score for the whole area.
Work techniqueDuring the intervention period, every week from baseline to six months follow-up.Participating AN will receive a weekly SMS question: "How well has your work technique functioned this week in relation to safe patient handling and movement? (0 = not at all well; 10 = very well)."

Secondary

MeasureTime frameDescription
Health related quality of lifeBaseline, 6 week, 6 monthHealth-related quality of life will be assessed using the EQ-5D-5L Swedish version (permission to be used Aug. 18, 2026, tracking number 87167). The instrument consists of five questions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression (1 = no problem; 5= unable to extreme problems). The health state is defined by combining one level from each of the five dimensions to an index score (0.31 = the worst to 1 = the best) health state. This is one instrument, the results of the instrument is presented as an index score only according to the EQ manual and as commonly used.
EQ-VASBaseline, 6 weeks, 6 monthEQ-VAS (vertical thermometer) (0 = the worst health you can imagine; 100 = the best health you can imagine). (Permission to be used Aug. 18, 2026, tracking number 87167.)
Neck Disability IndexBaseline, 6 week, 6 monthThe impact of neck pain on daily life will be evaluated using the Neck Disability Index (NDI) (percentage from 0% to 100%, with higher scores indicating greater neck-related disability).
QuickDASH-7Baseline, 6 week, 6 monthUpper limb function will be assessed using the modified QuickDASH-7 (0 = no disability; 100 = most severe disability)
Oswestry Low Back Pain QuestionnaireBaseline, 6 week, 6 monthFunctional limitations related to low back pain will be assessed using the Oswestry Low Back Pain Questionnaire version 2.1 (percentage from 0% to 100%, with higher scores indicating greater low-back-related disability).
Work abilityBaseline, 6 week, 6 monthWork ability will be assessed using Question 1 of the Work Ability Index (WAI) (0 = completely unable to work; 10 = work ability at its lifetime best).
Multidisciplinary Work Evaluation ToolBaseline, 6 week, 6 monthProblems related to the physically, environmentally and psychosocially demanding aspects of the work environment will be assessed using the Structured Multidisciplinary Work Evaluation Tool (SMET) rated on a 10-point scale (1-11). Responses will be trichotomized into scores 1-3 = "a low degree of problems," 4-7 = "a moderate degree of problems," and 8-10 = "a high degree of problems."
StressBaseline, 6 week, 6 monthPerceived stress will be assessed using a single-item question: "Have you felt stressed recently?" (1 = not at all; 5 = very much)
Perceived exertionBaseline, 6 week, 6 monthPerceived physical exertion at work will be assessed using the Borg Category Ratio Scale (0 = no exertion at all; 10 = extremely strong or maximal exertion) (CR-10) and will also be applied in relation to patient transfers, as reported in previous research
Patient transfersBaseline, 6 week, 6 monthThe number of patient transfers performed during a typical working day will be assessed using the Number of Daily Patient Transfers measure (higher values = more patient transfers performed per day, with no fixed highest value)
ProductivityBaseline, 6 week, 6 monthExperiences of work environment-related problems that have affected health, work performance, or sickness presence (presenteeism) during the preceding seven days will be assessed on a 0-10 scale (higher scores indicate greater negative impact).
Psychosocial safety climateBaseline, 6 week, 6 monthPsychosocial safety climate will be assessed using the four-item Psychosocial Safety Climate Scale (4-20 scale, higher categories indicating higher level of safety climate).
Physical activityBaseline, 6 week, 6 monthTwo questions concerning physical activity (1 = 0 minutes to 6 \> 300 minutes) and exercise (1 = 0 minutes to 6 \> 120 minutes) will be used, with higher categories indicating a higher level of physical activity.
Need for recoveryBaseline, 6 week, 6 monthThe need for recovery will be measured using the short version of the Need for Recovery Scale, consisting of three items (0-3 scale, higher scores indicate a greater need for recovery).
Patient-Specific Functional ScaleBaseline, 6 week, 6 monthParticipants will identify work-related activities that they find difficult to perform and rate the importance of these activities at baseline, six weeks and six months follow-up using the Patient-Specific Functional Scale (PSFS) (0 = unable to perform the activity at all; 10 = able to perform)
Expectations and goal settingBaseline, 6 week, 6 monthDuring the assessment, participants will be asked to rate their expectations regarding participation in the study, particularly in relation to increasing their knowledge of OSH, ergonomics and PHM competence. Participants will also formulate individual goals, describing what they wish to achieve through participation and identifying factors that may facilitate or hinder goal attainment.
Pain intensity last weekBaseline, 6 week, 6 monthDescription: Pain intensity: Overall work-related musculoskeletal disorders pain intensity in the back/neck/shoulder area during the last week will be measured using the Numeric Rating Scale (NRS 0-10, higher levels indicate more severe pain). One score only for the whole area. Time Frame: Baseline, 6-week, 6-month
Neck pain intensityBaseline, 6 week, 6 monthCurrent neck pain intensity on the NRS Scale (NRS 0-10, higher levels indicate more severe pain).
Current low back pain intensityBaseline, 6 week, 6 monthCurrent low back pain intensity (NRS 0-10, higher levels indicate more severe pain).
Current shoulder pain intensityBaseline, 6 week, 6 monthCurrent shoulder pain intensity (NRS 0-10, higher levels indicate more severe pain).

Contacts

CONTACTAnneli Peolsson, Professor, PhD
anneli.peolsson@liu.se+4613284601
CONTACTCharlotte Wåhlin, Assoc. Prof., PhD
Charlotte.Wahlin@liu.se+46722396640
PRINCIPAL_INVESTIGATORAnneli Peolsson, Prof., PhD

1. Dep. of Health Medicine and Caring Sciences, Physiotherapy, Linköping University, Linköping, and 2. Clinical Occupational and Environmental Medicine Centre, Dep. of Health Medicine and Caring Sciences, Clinical Medicine, Linköping Univiversity, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026