Clinical trial NCT04246736: A Proactive Intervention Promoting Strategies for Sleep and Recovery in Nurses
Official title: Bädda för Kvalitet: Proaktiva Strategier för återhämtning i främjandet av hälsa Och Arbetsprestation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Occupational Stress
Fatigue
Behavior, Health
Burnout
Sleepiness
Shift-Work Related Sleep Disturbance
Cognitive Symptom
Insomnia
Keywords: sleep
fatigue
stress
recovery
occupational
shiftwork
strategies
work performance
burnout
sleepiness
newly graduated nurses
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: AFA Insurance
First posted: 2020-01-29
Enrollment: 207
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomised into intervention group and control group. The intervention group received the intervention and were followed-up until 6 months after the intervention. After that, the control group received the intervention.
Primary purpose: PREVENTION

Brief summary: Considering the known challenges facing newly graduated nurses, there are possibilities to implement preventive actions. The aim of the current study was to evaluate the effects of a preventive intervention among newly graduated nurses, supporting proactive strategies for sleep and recuperation in relation to work related stress and shift work.

Detailed description: Approximately 20% of all Swedish nurses experiences very high levels of burnout symptoms at some point during the first years of practice. Many factors are likely to be involved, and when developing methods to facilitate the nurse's transition from education into working life, a variety of stressors at both the organisational and individual level have to be considered. Previously, incomplete recovery has been suggested to mediate the relation between stressful working conditions and health impairment. For many, starting working as a nurse also means an introduction to shiftwork, which inevitably affects opportunities for sleep and recuperation due to interference with the circadian and homeostatic regulation of sleep. Given the vital role of sleep and recovery in the relationship between stress and development of impaired health, effective strategies for sleep and recuperation are hypothesised to be crucial in preventing the development of stress-related symptoms among nurses. In addition, lack of sleep and recuperation results in fatigue, which is a major safety hazard threatening patient safety. The aim of the current study was to evaluate a preventive intervention for new nurses, supporting strategies for sleep and recuperation in relation to work related stress and shift work.

Recruitment Newly graduated nurses were recruited at five Swedish hospitals. The recruitment was done via the introduction programmes, except from at one of the hospitals (which did not have such a programme) where the nurses instead were recruited via the different clinics. In total the intervention was implemented in eight different cohorts during 2017 and 2018. Approximately 462 newly graduated nurses were invited to participate in the study and 207 joined and answered the baseline questionnaire (45%).

Design The participants were randomly assigned to intervention and control groups. The participants were followed with questionnaires Participants were followed with either questionnaires or questionnaires + intesive measures using diary, actigraphy and cognitive tests. Questionnaires were filled in before the intervention (baseline), one month after the intervention (post), and at six months after the intervention (follow-up). The intensive measure was conducted at baseline and post intervention.

The participants also got a short questionnaire to fill out at the start of session two and three, and two weeks after session three, in which they filled out which strategies they had used during the last couple of weeks. After the last session, participants were asked to evaluate the intervention using a short questionnaire.

The intervention The intervention was a preventive programme focusing on beneficial strategies for sleep and recuperation in relation to work stress and shift work. The programme included three 2.5 hours-group sessions every second week. The sessions were taking place at work during working hours. The intervention was based on knowledge from research on sleep, stress and work hours, as well as on cognitive behavioural therapy (CBT) techniques for sleep and stress management modified for shift workers. The regulation of sleep and wakefulness was explained by the three factors: 1) circadian rhythm, 2) homeostatic process, and 3) stress, referred to as the sleep formula. How these factors interacts with irregular work hours was explained. Participants were encouraged to reflect on their daily habits related to sleep and recovery. Also, a CBT-model for analysing behaviours in stressful work situations were used in order to encourage participants to reflect on their usual behaviours and possible alternatives. As homework between sessions, the participants were encouraged to try possibly beneficial strategies for sleep and recuperation. The participants got written material, after every session, covering the content of the session. In addition, the participants got access to an adapted version of the biomathematical model (ArturNurse) to give participants an estimation of expected sleep lengths and fatigue levels together with tips of possible strategies to optimise sleep in relation to different shifts.

Eligibility criteria: Inclusion Criteria:

* Newly graduated nurse in the first year of employment

No Exclusion Criteria.

Primary outcomes:
measure: Change in insomnia symptoms (subjective measure)
timeFrame: In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
measure: Change in sleep quality (subjective measure)
timeFrame: In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
measure: Change in Dysfunctional beliefs and attitudes about sleep (subjective measure)
timeFrame: In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
measure: Change in sleep (subjective measure)
timeFrame: In order to detect change measures were made at baseline to 4 weeks after the intervention. Measured seven days at baseline and seven days at follow up.
measure: Change in satisfaction with sleep
timeFrame: In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
measure: Change in subjective sleep quality
timeFrame: In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
measure: Change in sleep (objective measures)
timeFrame: In order to detect change measures were made at baseline and at 4 weeks after the intervention. Measured seven days at baseline and seven days at follow up.
measure: Change in work home interference (subjective measures)
timeFrame: In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
measure: Change in fatigue and recuperation (subjective measures)
timeFrame: In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
measure: Change in diurnal levels of sleepiness (subjective measures)
timeFrame: In order to detect change measures were made at baseline and 4 weeks after the intervention.
measure: Change in symptoms of sleepiness and fatigue (subjective measures)
timeFrame: In order to detect change measures were made at baseline to 4 weeks after the intervention.
measure: Change in burnout (subjective measure)
timeFrame: In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
measure: Change in perceived stress (subjective measure)
timeFrame: In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
measure: Change in stress and energy (subjective measures)
timeFrame: In order to detect change measures were made at baseline and 4 weeks after the intervention.
measure: Change in stress symptoms (subjective measures)
timeFrame: In order to detect change measures were made at baseline and 4 weeks after the intervention.
measure: Change in diurnal levels of stress (subjective measures)
timeFrame: In order to detect change measures were made at baseline and 4 weeks after the intervention.
measure: Change in stress (objective measures)
timeFrame: In order to detect change measures were made at baseline and 4 weeks after the intervention.
measure: Change in somatic symptoms
timeFrame: In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
measure: Change in health
timeFrame: In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
measure: Change in psychological health
timeFrame: In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
measure: Change in self rated health
timeFrame: In order to detect change measures were made at baseline and 4 weeks after the intervention.
measure: Change in performance and cognitive symptoms (subjective measures)
timeFrame: In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
measure: Change in performance and cognitive symptoms (subjective measures)
timeFrame: In order to detect change measures were made at baseline and 4 weeks after the intervention. Measured seven days at baseline and seven days at follow up.
measure: Change in performance, arithmetic ability (objective measures)
timeFrame: In order to detect change tests were made at baseline (one day, during and after work) and 4 weeks after the intervention (one day, during and after work).
measure: Change in performance, episodic memory (objective measures)
timeFrame: In order to detect change tests were made at baseline (one day, during and after work) and 4 weeks after the intervention (one day, during and after work).
Secondary outcomes:
measure: Changes in work measures
timeFrame: Baseline, 4 weeks after the intervention and 6 months after the intervention.
measure: Changes in working hours
timeFrame: Baseline, 4 weeks after the intervention and 6 months after the intervention.
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Huddinge
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Linköping
country: Sweden
facility: Universitetssjukhuset
city: Ljungby
country: Sweden
facility: Lasarettet Ljungby
city: Norrköping
country: Sweden
facility: Vrinnevisjukhuset
city: Solna
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Växjö
country: Sweden
facility: Centrallasarettet
Study officials:
References:
citation: Dahlgren A, Tucker P, Epstein M, Gustavsson P, Soderstrom M. Randomised control trial of a proactive intervention supporting recovery in relation to stress and irregular work hours: effects on sleep, burn-out, fatigue and somatic symptoms. Occup Environ Med. 2022 Jul;79(7):460-468. doi: 10.1136/oemed-2021-107789. Epub 2022 Jan 24.