Reducing Pain-Related Sickness Absence Through Workplace Health Literacy: A Hybrid II Study

NCT07707180 | Not Yet Recruiting

• 2 other identifiers: F-26029871186523
• Study Type: interventional
• Target: 193
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary aim of this study is investigate whether a workplace intervention targeting employees' and managers' understanding of pain and communication (called occupational health literacy) can reduce pain-related sick leave and help employees and managers to better understand and manage work-related health matters. The study also aims to learn how the program works, who it works best for (or not), and how it can be successfully used long-term in real workplaces, especially in production environments. The study will e.g. examine whether the program:

• reduces the number of sick days caused by pain,
• lowers how much pain employees feel, and
• improves employees' and managers' understanding of health and how to improve it. Expectation: Employees who participate in the program will:
• take fewer sick days because of pain,
• experience less pain, and have better health knowledge and skills than employees who continue with normal workplace practices. The study will identify:
• what makes the program difficult or easy to introduce at workplaces,
• which strategies help it succeed, and
• what factors make the program continue working over time. Goal: Help workplaces adopt and maintain the program successfully.

Conditions

Healthy; Musculoskeletal Disorders; Occupational Health; Occupational Health Literacy

Keywords

occupational workplace health literacy; pain related sickness absence; pain communication; structured dialogues

Outcome Measures

Primary Outcomes (2)

• Pain-related sickness absence

  The primary outcome measure for effectiveness in this Hybrid 2 study, is self-reported pain-related sickness absence. Pain-related sickness absence will be assessed at baseline and every second week based on a questionnaire distributed by text messages to employees. The question to answer is: "In the last 4 weeks, how many days have you called in sick from work due to muscle pain?"

  The time frame will be from baseline to end of intervention at 16 weeks. Seeing that this is a stepped wedge RCT, baseline is before entering the control-period.

• Implementation appropriateness

  The primary implementation outcome in this Hybrid 2 study is Appropriateness. Appropriateness is evaluated with the IAM- Intervention Appropriateness Measure. It consists of 4 items rated on a Likert scale (e.g., strongly disagree to strongly agree), with statements such as whether the intervention seems fitting, suitable, applicable, or a good match for the setting. The measure will be evaluated by the Workplace champions, employees and managers through telephone interviews after the interventions ends at 16 weeks. Appropriateness is also explored through elements of the RE-AIM (secondary outcomes) evaluation (Adoption, Implementation and Maintenance) at 16 weeks through interviews (see secondary outcomes).

  IAM is evaluated at 16 weeks, and through "Maintenance" 4 months after intervention end. Adoption and Implementation is evaluated after intervention end at 16 weeks.

Secondary Outcomes (1)

• Pain intensity

  From baseline, before entering the stepped wedge control period, to the end of treatment at 16 weeks

Other Outcomes (7)

• Adoption

  Adoption is evaluated at the end of intervention, at 16 weeks.

• Organizational Workplace Health Literacy

  Organizational Workplace Health Literacy will be assessed at baseline, once a month and at the end of the intervention after 16weeks.

• Implementation fidelity

  Workplace champion, employees and managers will be interviewed at intervention end after 16 weeks.

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group receives the described intervention targeting improved occupational health literacy, consisting of three components: 1. A needs assessment 2. Digital education 3. Structured 1:1 dialogues between worker and supervisor

Behavioral: Cognitive behavioural therapy-inspired digital education on pain and communication

Control Group

OTHER

While waiting for cross over, the control group can use available resources within the local working environment initiatives at the workplace.

Other: Local work environment guidelines

Interventions

Cognitive behavioural therapy-inspired digital education on pain and communication BEHAVIORAL

The main content of the intervention consists of 4 elements: 1. An educational day session for the local workplace champion, with a main focus on the ability to faciliate a digital education for the employees and managers. 2. An initial needs and resource assessment at the workplace focused on pain and health literacy, with participants from all organizational layers; employee, managers, HR and the workplace champion. The assessment aims to empower workplaces to self-assess their needs, contributing to own autonomy and direction. The session is facilitated by the researcher. 3. 2\*2 hours and 1\*2 hour booster session of digital education for the employees and managers seperately, focusing on pain knowledge and communication, and finding solutions for work. 4. A period of 4 months with structured 10-minutes 1:1 dialogues between an employee and the manager every 3-5 weeks, using the tools and communication from the educational content.

Intervention group

Local work environment guidelines OTHER

While waiting for cross over, the control group can use available resources within the local working environment initiatives at the workplace.

Also known as: Control group

Control Group

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• each team needs a minimum of 15 employees
• the work environment organization at the workplace wants to participate in the study. All employees and managers are invited to participate.

Sponsors & Collaborators

• National Research Centre for the Working Environment, Denmark: lead
• University of Southern Denmark: collaborator

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Mia Nyvang Stilling, PhD student

CONTACT

+4551795855; mng@nfa.dk

Sebastian Venge Skovlund, PhD

CONTACT

svs@nfa.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This is a stepped wedge cluster-RCT.

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 16, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): May 30, 2028
• Last Updated: July 16, 2026

Record last verified: 2026-07