NCT05307107

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2022

Completed
26 days until next milestone

Study Start

First participant enrolled

February 7, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2022

Completed
Last Updated

December 13, 2022

Status Verified

December 1, 2022

Enrollment Period

4 months

First QC Date

January 12, 2022

Last Update Submit

December 11, 2022

Conditions

Keywords

educatoroccupational well-beingworking hoursphysical activityinterventionrecoverybreak

Outcome Measures

Primary Outcomes (2)

  • 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 \[9-item developed for this study and 7 items from "Occupational well-being of social and health care teachers - index questionnaire" (Saaranen et al., 2007)\]

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

  • 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/)

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

Secondary Outcomes (2)

  • Change in Overall occupational well-being

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

  • Change in General well-being

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

Other Outcomes (7)

  • Change of Physical activity_condition

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

  • Change of Recovery_condition

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

  • Change of Self-regulation_condition

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

  • +4 more other outcomes

Study Arms (2)

Intervention group (IG)

EXPERIMENTAL

Participants are educators working in health and social care education receiving 8 work week-SHINE.

Behavioral: SHINE

Control group (CG)

NO INTERVENTION

Participants 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).

Interventions

SHINEBEHAVIORAL

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).

Intervention group (IG)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jenni Rinne

Turku, 20540, Finland

Location

Related Publications (10)

  • 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.

    PMID: 29220738BACKGROUND
  • 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.

    PMID: 24054542BACKGROUND
  • 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.

    PMID: 17638488BACKGROUND
  • 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.

    PMID: 21659903BACKGROUND
  • 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.

    PMID: 26147541BACKGROUND
  • 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.

    PMID: 31662031BACKGROUND
  • 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.

    PMID: 30243696BACKGROUND
  • 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.

    PMID: 31856356BACKGROUND
  • 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.

    PMID: 25791983BACKGROUND
  • 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.

    PMID: 16880218BACKGROUND

Related Links

MeSH Terms

Conditions

Motor ActivitySelf-Control

Condition Hierarchy (Ancestors)

BehaviorSocial Behavior

Study Officials

  • Helena Leino-Kilpi, PhD

    University of Turku

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 12, 2022

First Posted

April 1, 2022

Study Start

February 7, 2022

Primary Completion

May 29, 2022

Study Completion

May 29, 2022

Last Updated

December 13, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

This data is available only for this study

Locations