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

September 1, 2026 updated by: Anneli Peolsson, Linkoeping University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group A. Patient handling and movement training

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
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.
Active Comparator: Group B. Patient handling and movement training plus biofeedback
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: Baseline, 6-week, 6-month
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
Time Frame: During 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)."
During the intervention period, every week from baseline to six months follow-up.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health related quality of life
Time Frame: Baseline, 6 week, 6 month
Health-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.
Baseline, 6 week, 6 month
EQ-VAS
Time Frame: Baseline, 6 weeks, 6 month
EQ-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.)
Baseline, 6 weeks, 6 month
Neck Disability Index
Time Frame: Baseline, 6 week, 6 month
The 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).
Baseline, 6 week, 6 month
QuickDASH-7
Time Frame: Baseline, 6 week, 6 month
Upper limb function will be assessed using the modified QuickDASH-7 (0 = no disability; 100 = most severe disability)
Baseline, 6 week, 6 month
Oswestry Low Back Pain Questionnaire
Time Frame: Baseline, 6 week, 6 month
Functional 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).
Baseline, 6 week, 6 month
Work ability
Time Frame: Baseline, 6 week, 6 month
Work 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).
Baseline, 6 week, 6 month
Multidisciplinary Work Evaluation Tool
Time Frame: Baseline, 6 week, 6 month
Problems 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."
Baseline, 6 week, 6 month
Stress
Time Frame: Baseline, 6 week, 6 month
Perceived stress will be assessed using a single-item question: "Have you felt stressed recently?" (1 = not at all; 5 = very much)
Baseline, 6 week, 6 month
Perceived exertion
Time Frame: Baseline, 6 week, 6 month
Perceived 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
Baseline, 6 week, 6 month
Patient transfers
Time Frame: Baseline, 6 week, 6 month
The 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)
Baseline, 6 week, 6 month
Productivity
Time Frame: Baseline, 6 week, 6 month
Experiences 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).
Baseline, 6 week, 6 month
Psychosocial safety climate
Time Frame: Baseline, 6 week, 6 month
Psychosocial safety climate will be assessed using the four-item Psychosocial Safety Climate Scale (4-20 scale, higher categories indicating higher level of safety climate).
Baseline, 6 week, 6 month
Physical activity
Time Frame: Baseline, 6 week, 6 month
Two 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.
Baseline, 6 week, 6 month
Need for recovery
Time Frame: Baseline, 6 week, 6 month
The 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).
Baseline, 6 week, 6 month
Patient-Specific Functional Scale
Time Frame: Baseline, 6 week, 6 month
Participants 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)
Baseline, 6 week, 6 month
Expectations and goal setting
Time Frame: Baseline, 6 week, 6 month
During 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.
Baseline, 6 week, 6 month
Pain intensity last week
Time Frame: Baseline, 6 week, 6 month

Description: 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
Baseline, 6 week, 6 month
Neck pain intensity
Time Frame: Baseline, 6 week, 6 month
Current neck pain intensity on the NRS Scale (NRS 0-10, higher levels indicate more severe pain).
Baseline, 6 week, 6 month
Current low back pain intensity
Time Frame: Baseline, 6 week, 6 month
Current low back pain intensity (NRS 0-10, higher levels indicate more severe pain).
Baseline, 6 week, 6 month
Current shoulder pain intensity
Time Frame: Baseline, 6 week, 6 month
Current shoulder pain intensity (NRS 0-10, higher levels indicate more severe pain).
Baseline, 6 week, 6 month

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Background data, age
Time Frame: Baseline, 6 week, 6 month
Year of birth (open-ended response)
Baseline, 6 week, 6 month
Implementation outcome, IAM
Time Frame: 6 week, 6 month
Implementation outcomes will be assessed at 6-week and 6-month follow-up using Acceptability of Intervention Measure (AIM). The questionnaire comprise four items, answered on 5-point Likert-type scales: (1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree
6 week, 6 month
Evaluation of biofeedback training
Time Frame: 6 week, 6 month
Evaluation of biofeedback training (Group B only) at 6-week and 6-month follow-up: Participants will complete two six-item questionnaires on vibrotactile biofeedback. The first assesses usefulness, comfort and motivation, based on the Intrinsic Motivation Inventory, and whether repeated use improves interpretation of vibration signals and work technique. Scores are reported as mean values (1-7) or summed scores (6-43), with higher scores indicating more positive experiences.
6 week, 6 month
Background data from the unit manager, number of employees
Time Frame: Baseline
At baseline unit managers provide information on the healthcare service unit in which the participating AN is employed, including the number of employees
Baseline
Interviews with AN
Time Frame: 6 week
Interviews with AN: To explore participants' experiences of the intervention at the six-week follow-up, semi-structured individual interviews (preferable physical meeting) will be conducted with a sample from both Group A and Group B (n ≈ 15). The interviews will explore participants' experiences of work tasks, the working conditions and safety culture in relation to nursing care and safe PHM. They will address perceived challenges, support from colleagues and managers, staff and patient safety during transfers, access to assistive devices, and experiences of implementing new work practices. The interviews will also examine participants' perceptions of the theoretical and practical training, the usefulness of the intervention in daily work, the role of biofeedback where applicable, and opportunities for sustaining and extending safe PHM practices within the workplace or organisation.
6 week
Interviews with managers
Time Frame: 6 week
Interviews with managers: Following completion of the intervention at the six-week follow-up, semi-structured interviews will be conducted with a purposive sample of managers whose AN participated in the study, with the aim of exploring their experiences of the project. Approximately 10 managers will be recruited. The manager interviews will explore managers' experiences of organisational conditions for safe PHM, including their role in systematic OSH management, safety culture, risk assessment, staff and patient safety, access to assistive devices, and organisational support. The interviews will also address managers' perceptions of the intervention, its implementation in daily nursing care, the use of biofeedback where applicable, and opportunities for sustaining and scaling safe PHM practices within the workplace or organisation.
6 week
ICD-10
Time Frame: Baseline
Diagnostic classification will be performed according to ICD-10 criteria, based on the clinical interview and functional assessment. A physiotherapist will conduct a clinical interview regarding AN's musculoskeletal symptoms affecting the neck/shoulder region and/or back in relation to their occupational activities. Clinical functional assessment at baseline (Week 1) will include screening of mobility and musculoskeletal function using the methodology "Medical Surveillance for Ergonomically Demanding Work (MEBA)".
Baseline
Screening for psychosoicial risk-factors associated with pain
Time Frame: Baseline
Screening for psychosocial risk factors associated with the development of persistent pain and long-term disability will be performed using the Örebro Musculoskeletal Pain Questionnaire
Baseline
Technical evaluation of biofeedback training (Group B only)
Time Frame: Baseline and 6 week
Training frequency and duration will be documented in a training diary. A technical evaluation will be conducted to enable pre-post comparisons at baseline and 6-weeks follow-up. Assessments will be performed during three standardised and commonly occurring work tasks: bed making with the patient in bed, repositioning a patient higher up in bed, and transferring a patient from bed to a wheelchair. The evaluation will be based on the distribution of body segment angles, angular velocities, and the amount of vibration feedback received during task performance.
Baseline and 6 week
Background data, duration of employement
Time Frame: baseline, 6 week, 6 month
Duration of employment (0-2 years, 2-5 years, 5-10 years, >10 years)
baseline, 6 week, 6 month
Background data, employement status
Time Frame: Baseline, 6 week, 6 month
Full-time/part-time employment status (%).
Baseline, 6 week, 6 month
Implementation outcome, IAM
Time Frame: 6 week, 6 month
Implementation outcome will be assessed at 6-week and 6-month follow-up using Intervention Appropriateness Measure (IAM). The questionnaire comprise four items, answered on 5-point Likert-type scales: (1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree
6 week, 6 month
Implementation outcome, FIM
Time Frame: 6 week, 6 month
Implementation outcome will be assessed using Feasibility of Intervention Measure (FIM). The questionnaire comprise four items, answered on 5-point Likert-type scales: (1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree
6 week, 6 month
Unit manager, age distribution of employees
Time Frame: Baseline
At baseline unit managers provide information on the healthcare service unit in which the participating AN is employed, including the age distribution
Baseline
Unit manager, gender distrbution of employees
Time Frame: Baseline
At baseline unit managers provide information on the healthcare service unit in which the participating AN is employed including gender distribution
Baseline
Unit manager, current sickness absence of employees
Time Frame: Baseline
At baseline unit managers provide information on the healthcare service unit in which the participating AN is employed, including the current sickness absence rates
Baseline
Unit manager, patient groups cared for
Time Frame: Baseline
At baseline unit managers provide information on the healthcare service unit in which the participating AN is employed, including the patient groups cared for.
Baseline
Unit manager, availability of work equipment
Time Frame: Baseline
At baseline unit managers provide information on the healthcare service unit in which the participating AN is employed, including the availability of work equipment.
Baseline
Continued training using biofeedback , group B only
Time Frame: 6 week
Comfort, technology acceptance and motivation for continued training will be rated on a seven-point Likert scale, with higher scores indicating more positive experiences.
6 week
Evaluation of e-learning
Time Frame: 6 week
Evaluation of e-learning will be completed immediately after participants have undertaken the theoretical e-learning module. Participants will evaluate perceived learning, understanding, relevance and contribution to knowledge development, with higher scores indicating more favourable outcomes.
6 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Linkoeping University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Region Östergötland
Region Jönköping County
Department of Health, Medicin and Caring Science, Linköping University
AFA försäkring

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 18, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Linkoeping U

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

De-identified data may be made available from the PI on reasonable request, subject to ethical and legal restrictions.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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