AzTrials
AzTrials

Well-beingSHINENCT05307107

Educators' Digital Occupational Well-being Intervention During Working Hours

A study testing SHINE in people with Well-being and Physical Activity, run by University of Turku at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This controlled quasi experimental intervention study follows the MRC framework for complex interventions (Bleijenberg et al. 2018) aiming to promote educators' individual aspect of occupational well-being. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Well-being, Physical Activity, Recovery
What is being tested?
SHINE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteFinland
Study dates
7 Feb 2022to 29 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Working as qualified educator (at least qualification of EQF 7) in secondary health and social care education
  • Full-time work contract
  • Having at least one-year employment in the organization

Who cannot join

  • having pacemaker or being pregnant (cause of the HRV measures)

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • Jenni Rinne

    Turku, 20540

Other trials in Finland

About this study

Official title: Recognize the Power Within and SHINE - Educators' Digital Occupational Well-being Intervention in Health and Social Care Education

This controlled quasi experimental intervention study follows the MRC framework for complex interventions (Bleijenberg et al. 2018) aiming to promote educators' individual aspect of occupational well-being. The purpose of this study is: 1) to evaluate the effectiveness of 8-workweek SHINE (= Self-Help INtervention for Educators) on educator's individual aspect of occupational well-being comparing intervention and control groups and 2) to describe the possible associating factors for the effectiveness of the intervention (if any) and 3) to evaluate SHINE's acceptability (utility and usability) within intervention group.

Read the detailed description

Overall Occupation Well-being (OW) is seen through four aspects of working life: 1) workers's resources and work (individual aspect), 2) work community, 3) working conditions and 4) professional competence (Saaranen et. al 2007). This study focuses in the individual aspect of OW, worker's resources and work and associating factors. This evidence base digital SHINE intervention is conducted in Finland within five different social and health care educational organizations randomly allocated either in intervention group (n=2) or in control group (n=3). Participants are working as qualified full-time educators in these organizations; intervention group (n=39) and control group (n=41). The intervention consists of four components: 1) physical activity, 2) recovery, 3) self-regulation and 4) workplace support designed to promote worker's resources at work. First three of these components are in digital program called, Smart Break SHINE. Educators' does short 3 minute exercises twice/workday (movement and breathing mind/body exercises) and additionally completes weekly reflective wellness actions during working hours. Last component, workplace support, comes from educators' organizations enabling time support and encouraging educators' to conduct these exercises during working hours taking approximately 10-15 min/workday. Control group continues their normal daily routines without this program.

Aim of this intervention is to promote educators' individual aspect of occupational well-being, the balance between individual resources and workload factors, during working hours. Main outcome is resource-workload-balance (RSW) and heart rate variability (HRV) and secondary outcomes are general well-being (GW) and overall occupational well-being (OW). Other outcomes are SHINE-components being associating factors in individual aspect of OW, physical activity, recovery, self-regulation and workplace support (condition outcomes). Also the usability and utility of the intervention is studied from the intervention group after using the program 8 workweeks.

Being tested
SHINE
Keywords
educator, occupational well-being, working hours, physical activity, intervention, recovery, break
Medical subject headings
Motor Activity, Self-Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHINEBehavioural

    Intervention group will use a 8-workweeks the digital Smart Break SHINE program with workplace support (encouragement and time-support) including daily 3 minutes break exercises twice a day; 1) physical exercise - break and 2) body/mind breathing exercise - break earning stars for exercise completed. The program includes weekly self-reflective task of individual well-being during working hours with weekly changing theme (avoiding sitting time, nature benefits, relaxation exercises, increasing physical activity in workplace etc.) earning diamonds for every weekly task completed. Participants self-monitors their weekly individual resources levels asked in every Thursday (1-5, 1= very poor. 5= very good). Program includes e-mail remainders set by participant themselves for suitable time frame These individual well-being actions takes approximately 15 minutes/workday. Control group will receive this program after this study (waitlist protocol).

Study groups in NCT05307107
Study groupRoleWhat they receive
Intervention group (IG)ExperimentalParticipants are educators working in health and social care education receiving 8 work week-SHINE.
Receives: Behavioral: SHINE
Control group (CG)No interventionParticipants are educators working in health and social care education without the program continuing their normal daily routines receiving SHINE for their voluntary use after this study (waitlist).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in resource-workload-balance

    Change in resource-workload-balance. 16-item self-reported questionnaire with continuous scale 1-5 (1= very poor - 5= very good).

    Questionnaire consists of questions of personal resources at work and workload factors [9-item developed for this study and 7 items from "Occupational well-being of social and health care teachers - index questionnaire" (Saaranen et al., 2007)]

    Measured: pre (week before enrollment) /post (after 8-workweeks) /follow-up (after 12 weeks of enrollment)

  2. Change in HRV

    Change in physical heart rate variability (=HRV). Change in the HRV (try to increase heart rate variability); in the variation in the time interval between consecutive heartbeats in milliseconds (ms).

    Heart rate variability (HRV) 3 minutes measurements are performed in work mornings at rest using Kubios HRV mobile application and a compatible belt-heart rate sensor (Polar H10 or H7). The beat-to-beat RR interval data (i.e. time intervals between successive heart beats) is pre-processed and analyzed at Kubios (Tarvainen et al. 2014; https://www.kubios.com/)

    Measured: pre (week before enrollment) /post (after 8-workweeks) /follow-up (after 12 weeks)

Secondary outcomes (2)

  1. Change in Overall occupational well-being

    Change in overall occupational well-being With one item: " I feel that my personal occupational well-being in this profession compared to the best possible level is" (continuous scale 0-5, 0= very poor - 5 = very good) from 'Occupational well-being of social and health care teachers - index questionnaire' (Saaranen et al., 2007).

    Measured: pre (week before enrollment) /post (after 8-workweeks) /follow-up (after 12 workweeks)

  2. Change in General well-being

    Change in individual's well-being in general. With 5-item "WHO5 well-being index-questionnaire" (https://www.corc.uk.net/outcome-experience-measures/the-world-health-organisation-five-well-being-index-who-5/).

    The WHO-5 consists of five statements, which respondents' rate according to the scale 0-5 (in relation to the past two weeks, 0= at no time- 5= all the time). The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.

    Measured: pre (week before enrollment) /post (after 8 workweeks) /follow-up (after 12 workweeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2022
  2. Study start7 Feb 2022
  3. Primary completion29 May 2022
  4. Study completion29 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Participants (n=80) are educators working in health and social care education in secondary level education in five different educational organizations, which have similar management systems and providing time-support to implement SHINE during working hours. Organizations are randomly assigned either in intervention group (IG, n=2) receiving SHINE or in control group (CG, n=3) without the program continuing their normal daily routines receiving SHINE for their voluntary use after this study.
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05307107
Sponsor's protocol ID
University of Turku_UTurku
Acronym
SHINE
Status last verified
Dec 2022
First submitted
12 Jan 2022
Last updated
13 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This data is available only for this study

Publications

  • Bleijenberg N, de Man-van Ginkel JM, Trappenburg JCA, Ettema RGA, Sino CG, Heim N, Hafsteindottir TB, Richards DA, Schuurmans MJ. Increasing value and reducing waste by optimizing the development of complex interventions: Enriching the development phase of the Medical Research Council (MRC) Framework. Int J Nurs Stud. 2018 Mar;79:86-93. doi: 10.1016/j.ijnurstu.2017.12.001. Epub 2017 Dec 5.

    PubMed 29220738

  • Tarvainen MP, Niskanen JP, Lipponen JA, Ranta-Aho PO, Karjalainen PA. Kubios HRV--heart rate variability analysis software. Comput Methods Programs Biomed. 2014;113(1):210-20. doi: 10.1016/j.cmpb.2013.07.024. Epub 2013 Aug 6.

    PubMed 24054542

  • Sonnentag S, Fritz C. The Recovery Experience Questionnaire: development and validation of a measure for assessing recuperation and unwinding from work. J Occup Health Psychol. 2007 Jul;12(3):204-21. doi: 10.1037/1076-8998.12.3.204.

    PubMed 17638488

  • Chau JY, Van Der Ploeg HP, Dunn S, Kurko J, Bauman AE. Validity of the occupational sitting and physical activity questionnaire. Med Sci Sports Exerc. 2012 Jan;44(1):118-25. doi: 10.1249/MSS.0b013e3182251060.

    PubMed 21659903

  • de Bloom J, Kinnunen U, Korpela K. Recovery Processes During and After Work: Associations With Health, Work Engagement, and Job Performance. J Occup Environ Med. 2015 Jul;57(7):732-42. doi: 10.1097/JOM.0000000000000475.

    PubMed 26147541

  • Hennessy EA, Johnson BT, Acabchuk RL, McCloskey K, Stewart-James J. Self-regulation mechanisms in health behavior change: a systematic meta-review of meta-analyses, 2006-2017. Health Psychol Rev. 2020 Mar;14(1):6-42. doi: 10.1080/17437199.2019.1679654.

    PubMed 31662031

  • Arian M, Soleimani M, Oghazian MB. Job satisfaction and the factors affecting satisfaction in nurse educators: A systematic review. J Prof Nurs. 2018 Sep-Oct;34(5):389-399. doi: 10.1016/j.profnurs.2018.07.004. Epub 2018 Jul 7.

    PubMed 30243696

  • Singh C, Cross W, Munro I, Jackson D. Occupational stress facing nurse academics-A mixed-methods systematic review. J Clin Nurs. 2020 Mar;29(5-6):720-735. doi: 10.1111/jocn.15150. Epub 2020 Jan 2.

    PubMed 31856356

  • Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O'Cathain A, Tinati T, Wight D, Baird J. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015 Mar 19;350:h1258. doi: 10.1136/bmj.h1258.

    PubMed 25791983

  • Saaranen T, Tossavainen K, Turunen H, Kiviniemi V, Vertio H. Occupational well-being of school staff members: a structural equation model. Health Educ Res. 2007 Apr;22(2):248-60. doi: 10.1093/her/cyl073. Epub 2006 Jul 31.

    PubMed 16880218

Questions about this trial

What is this clinical trial studying?

A study testing SHINE in people with Well-being and Physical Activity, run by University of Turku at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in resource-workload-balance (time frame: pre (week before enrollment) /post (after 8-workweeks) /follow-up (after 12 weeks of enrollment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05307107, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in