NCT07805629

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.

Trial Health

65
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Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
24mo left

Started Jan 2027

Typical duration for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 4, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

January 18, 2027

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

2 years

First QC Date

August 27, 2026

Last Update Submit

September 4, 2026

Conditions

Keywords

musculoskeletal disordersnursing assistantspatient transfersergonomicsbiofeedbackoccupational healthworkplace interventionrandomised controlled trial

Outcome Measures

Primary Outcomes (2)

  • Pain intensity

    Pain: 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.

    Baseline, 6-week, 6-month

  • Work technique

    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)."

    During the intervention period, every week from baseline to six months follow-up.

Secondary Outcomes (20)

  • Health related quality of life

    Baseline, 6 week, 6 month

  • EQ-VAS

    Baseline, 6 weeks, 6 month

  • Neck Disability Index

    Baseline, 6 week, 6 month

  • QuickDASH-7

    Baseline, 6 week, 6 month

  • Oswestry Low Back Pain Questionnaire

    Baseline, 6 week, 6 month

  • +15 more secondary outcomes

Other Outcomes (28)

  • Background data, age

    Baseline, 6 week, 6 month

  • Implementation outcome, IAM

    6 week, 6 month

  • Evaluation of biofeedback training

    6 week, 6 month

  • +25 more other outcomes

Study Arms (2)

Group A. Patient handling and movement training

ACTIVE COMPARATOR

Participants in both Groups A and B will during the first weeks receive a digital educational programme comprising modules delivered through educational platform of the county council of Östergötland. In addition, participants will receive a five-step checklist describing safe PHM, based on Safe Patient Handling - A Research-Based Guide for an Improved Work Environment. The educational content emphasises theoretical and practical training in PHM competence, including the importance of conducting risk assessments and evaluating risks associated with each patient transfer and other physically demanding work tasks. Participants will also receive practical instruction in PHM techniques within their own workplace.

Other: Group A. Patient handling and movement training

Group B. Patient handling and movement training plus biofeedback

ACTIVE COMPARATOR

Group B. As described above plus Biofeedback-supported work technique training. Participants in Group B will receive six weeks of self-administered biofeedback-supported work technique training in addition to PHM training. The system uses inertial measurement unit sensors attached to the trunk and upper arm to monitor back and arm postures during routine work activities, with particular focus on the neck/shoulder region and back (34, 35) (Figure 2). When unfavourable postures are detected, participants receive gentle vibratory feedback, increasing with less favourable postures and stopping when more ergonomic postures are adopted. After instruction and practical training, participants will use the system independently during ordinary work tasks to develop more ergonomic and less physically demanding techniques. The minimum dose is 10 sessions of at least 20 minutes over six weeks, although participants may complete longer or additional sessions if they wish.

Other: Group B: Patient handling and movement training plus biofeedback

Interventions

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.

Group A. Patient handling and movement training

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.

Group B. Patient handling and movement training plus biofeedback

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale assistant nurses
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Lind CM. A Rapid Review on the Effectiveness and Use of Wearable Biofeedback Motion Capture Systems in Ergonomics to Mitigate Adverse Postures and Movements of the Upper Body. Sensors (Basel). 2024 May 23;24(11):3345. doi: 10.3390/s24113345.

    PMID: 38894134BACKGROUND
  • Kugler HL, Taylor NF, Brusco NK. Patient handling training interventions and musculoskeletal injuries in healthcare workers: Systematic review and meta-analysis. Heliyon. 2024 Jan 26;10(3):e24937. doi: 10.1016/j.heliyon.2024.e24937. eCollection 2024 Feb 15.

    PMID: 38371982BACKGROUND
  • Wahlin C, Stigmar K, Nilsing Strid E. A systematic review of work interventions to promote safe patient handling and movement in the healthcare sector. Int J Occup Saf Ergon. 2022 Dec;28(4):2520-2532. doi: 10.1080/10803548.2021.2007660. Epub 2021 Dec 19.

    PMID: 34789085BACKGROUND
  • Lu L, Ko YM, Chen HY, Chueh JW, Chen PY, Cooper CL. Patient Safety and Staff Well-Being: Organizational Culture as a Resource. Int J Environ Res Public Health. 2022 Mar 21;19(6):3722. doi: 10.3390/ijerph19063722.

    PMID: 35329410BACKGROUND
  • Carayon P, Wetterneck TB, Rivera-Rodriguez AJ, Hundt AS, Hoonakker P, Holden R, Gurses AP. Human factors systems approach to healthcare quality and patient safety. Appl Ergon. 2014 Jan;45(1):14-25. doi: 10.1016/j.apergo.2013.04.023. Epub 2013 Jul 8.

    PMID: 23845724BACKGROUND
  • Agency for Work Environment Expertise. Safe patient handling - A research based guide for a better working environment.; 2022 Swedish Report No.: 978-91-987762-7-0. 2024 English report No.:978-91-89747-61-6.

    BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Biofeedback, Psychology

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • Anneli 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anneli Peolsson, Professor, PhD

CONTACT

Charlotte Wåhlin, Assoc. Prof., PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD, PT, HRMD

Study Record Dates

First Submitted

August 27, 2026

First Posted

September 4, 2026

Study Start (Estimated)

January 18, 2027

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

September 10, 2026

Record last verified: 2026-09