A Proactive Intervention Promoting Strategies for Sleep and Recovery in Nurses
Primary Purpose
Sleep, Occupational Stress, Fatigue
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Bädda för Kvalitet
Sponsored by
About this trial
This is an interventional prevention trial for Sleep focused on measuring sleep, fatigue, stress, recovery, occupational, shiftwork, strategies, work performance, burnout, sleepiness, newly graduated nurses
Eligibility Criteria
Inclusion Criteria:
- Newly graduated nurse in the first year of employment
No Exclusion Criteria.
Sites / Locations
- Sahlgrenska Universitetssjukhuset
- Karolinska Universitetssjukhuset
- Universitetssjukhuset
- Lasarettet Ljungby
- Vrinnevisjukhuset
- Karolinska Universitetssjukhuset
- Centrallasarettet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
The intervention group received a "Recovery programme" including three group sessions.
The control group was on a waiting list to receive the intervention after the last follow-up measure (six months after the intervention group's last group session).
Outcomes
Primary Outcome Measures
Change in insomnia symptoms (subjective measure)
Insomnia Severity Index (ISI) which consists of 7 questions related to sleep e.g. "How satisfied are you with your current sleep pattern?" (0 = very satisfied, 4 = very dissatisfied). The total score is summarised with a minimum score 0, maximum score 28. Higher scores indicate more sleep problems.
Change in sleep quality (subjective measure)
Karolinska Sleep Questionnaire (KSQ) from which a sleep quality index was formed based on four questions e.g. "Have you had problems falling asleep the past month"? etc : Minimum score 1, maximum score 6. Lower scores indicate worse sleep quality.
Change in Dysfunctional beliefs and attitudes about sleep (subjective measure)
Dysfunctional Beliefs and Attitudes about Sleep (DBAS) consists of 10 statements regarding beliefs and attitudes to sleep e.g. "I am concerned that chronic insomnia may have serious consequences on my physical health"; "When I have trouble sleeping, I should stay in bed and try harder" (strongly agree - strongly disagree): Minimum score 0, maximum score 10. Higher scores indicate more dysfunctional sleep-related cognitions.
Change in sleep (subjective measure)
Karolinska Sleep Diary (KSD). KSD includes bedtime; time of awakening; sleep latency (the time it takes to fall asleep); feelings of worry and stress at bedtime (1 very worried/aroused - 5 very calm/relaxed); and the following questions: Did you have difficulties falling asleep? (1 = very; 5 = not at all) How did you sleep? (1 = very badly; 5 = very good); Did you have a restless sleep? (1 = very much so; 5 = not at all); Did you wake up very early without being able to fall asleep? (1 = much too early; 5 = no). These four latter questions constitutes a sleep quality index, minimum score 1, maximum score 5: Lower scores indicate worse sleep quality.
Change in satisfaction with sleep
Self-rated sufficient sleep (5=very insufficient 1=fully sufficient)
Change in subjective sleep quality
Self-rated general sleep quality (1=very good 5=very bad).
Change in sleep (objective measures)
Actigraphy (wrist-watch). Measuring of movements during sleep through a sensitive accelerometer in the wrist-watch. The value, which is described as the amount of movements per minute, is saved in the memory of the actigraph. Preprogrammed algorithms make it possible to classify if the participant has slept or not. Measured seven nights at baseline and seven nights at follow up. Example of measures:
Actual sleep time: The total time spent in sleep according to the epoch-by-epoch wake/sleep categorisation.
Actual sleep %: Actual sleep time expressed as a percentage of the assumed sleep time.
Actual wake time: The total time spent in wake according to the epoch-by-epoch wake/sleep categorisation.
Wake bouts: The number of contiguous sections categorised as wake in the epoch-by- epoch wake/sleep categorisation.
Sleep fragmentation: The sum of the "Mobile time (%)" and the "Immobile bouts <=1min (%)". This is an indication of the degree of fragmentation.
Change in work home interference (subjective measures)
Work-Home Interference (WHI) measured with four items: "I come home from work too tired to do things I would like to do."; "My job makes it difficult to maintain the kind of personal life I would like."; "I often neglect my personal needs because of the demands of my work."; "My personal life suffers because of my work." Rated on a 5-graded scale ranging from 1=not at all to 5=almost always.
Change in fatigue and recuperation (subjective measures)
Single items (self-ratings): Frequency of recovery behaviours (e.g. micro breaks (1 = every shift, 5 = Never); routine for winding down before bedtime (1 = never, 5 = Always); Satisfaction regarding rest and recuperation during spare time (1 = fully sufficient, 5 = no, far from sufficient); Use of strategies for optimizing sleep and recuperation (1 = never, 5= always); General satisfaction with spare time (1 = very good, 5 = very bad); Use of free time before evening shifts (1 = never, 5 = always); Frequency of breaks during work shifts (1 = every shift, 5= never).
Change in diurnal levels of sleepiness (subjective measures)
Karolinska Sleepiness Scale (KSS): A nine-graded scale with values ranging from 1=very alert to 9=very sleepy, fighting sleep. Measured every third hour during wake time seven days at baseline and seven days at follow up.
Change in symptoms of sleepiness and fatigue (subjective measures)
Single items measuring symptoms of fatigue e.g. "sustained fatigue", "unfocused" and "engaged", on a five-graded scale ranging from 1=not at all, and 5=very much. Measured seven days at baseline and seven days at follow up.
Change in burnout (subjective measure)
Shirom-Melamed Burnout Questionnaire (SMBQ): Minimum score 1, maximum score 7. Higher scores indicate more burnout.
Change in perceived stress (subjective measure)
Perceived Stress Scale (PSS-10) which consists of 10 statements e.g.. "In the last month, how often have you felt nervous and "stressed"; "In the last month, how often have you found that you could not cope with all the things that you had to do"? etc: Answers on 0 = never, 4 = very often. These are summarised. Minimum score 0, maximum score 40. Higher scores indicate more stress.
Change in stress and energy (subjective measures)
Stress-Energy rating questionnaire: Minimum score 0, maximum score 5. Higher scores indicate more stress and more energy.
Change in stress symptoms (subjective measures)
Self-ratings of stress symptoms/absence of stress symptoms (single items): "Tense"; "Irritated"; "Exhausted"; "Hard to disconnect from thoughts of work during spare time"; "Emotional burden"; "Relaxed/calm" on a scale ranging from 1=not at all, and 5=very much. Measured every day during seven days at baseline and seven days at follow up.
Change in diurnal levels of stress (subjective measures)
Self-rated stress scale for repeated measurement, measured one a nine-graded scale with values ranging from 1=very low stress to 9=very high stress. Measured every third hour during wake time seven days at baseline and seven days at follow up.
Change in stress (objective measures)
Hair cortisol based on 2 cm segments (pg/mg)
Change in somatic symptoms
Somatic Symptoms Scale-8 (SSS-8): Minimum score 0, maximum score 32. Higher scores indicate higher somatic symptom burden.
Change in health
Single items: Self-rated health on a scale ranging from 1=very good to 7=very bad. Self-rated use of medical drugs the past three months (frequency as 1 = never, 5 = always), coffee consumption during a work day (1 = none, 5 = 7 cups or more); how often do you do 30 minutes of physical exercise (1 = never, 5 = 3 times of more/week).
Change in psychological health
Single items (self-ratings): How often have you during the past 7 days felt "depressed"; "stated"; "sad"; "worried"; "nervous"; "unsure" on a scale ranging from 0=not at all to 5=very much.
Change in self rated health
Self-rated health on a scale ranging from 1=very good to 7=very bad. Measured daily during seven days at baseline and seven days at follow-up.
Change in performance and cognitive symptoms (subjective measures)
Ratings (single items): Self-rated work performance through the following items: During the past month how often have you during you work .... "in risk of mistakes"; "found it hard to make decisions"; "been present during interaction with others"; "had to make corrections or double-check work tasks" (1 = never, 5 = Always). Sub-indices from SMBQ (described above) will also be used as measures of cognitive symptoms.
Change in performance and cognitive symptoms (subjective measures)
Self-ratings (single items) of how well the participant managed to (at work) make decisions; keep things in their head; keep track of the overall picture; perform tasks in a safe way; being present during interaction with others. Rated on a 5-graded scale ranging from 1=very well to 5=very badly.
Change in performance, arithmetic ability (objective measures)
Cognitive tests measuring executive functioning, performed on the participant's mobile phone. In the arithmetic ability task, the participant is presented with simple arithmetical addition questions and required to calculate the answer and type it into the phone. New questions are presented until the time is running out (duration 2 minutes). Performance is measured in terms of total score (correct responses during 2 minutes) and the speed of correct responses (in ms).
Change in performance, episodic memory (objective measures)
Cognitive tests measuring executive functioning, performed on the participant's mobile phone. In the episodic memory task, participants are presented with a list of 12 words for 12 seconds, which they are asked to remember. A fixation cross then appears for 5 seconds. Following this, participants are shown a list of 24 words, which contains the original 12 words, and an additional 12 dummy words, and are asked whether each word was previously shown (yes/no). The task is performed twice. Performance is assessed as percentage correct.
Secondary Outcome Measures
Changes in work measures
Single items (self-ratings): Satisfaction with work; Work environment ratings (e.g. tempo, emotional demands, control over work tasks, support, engagement, frequency of tasks in conflict with personal values, quality of cooperation with coworkers); Self-rated patient safety at workplace; Work time control (WTC) where the respondents rate on a five graded scale (1=very little to 5=very much) how much they are able to influence the following aspects of their working times: length of a work shift, the starting and ending times of a work shift, the taking of breaks during the work shift, the scheduling of work shifts, the scheduling of vacations and days off, and the handling of private matters during the workday
Changes in working hours
Single items (self-ratings):
Frequency (per month) of overtime work, night shifts and quick returns (less than 11 hours between shifts). Self-rated experiences of problems regarding these different type of shifts/shift combinations (yes/no), type of shift schedule, satisfaction with working hours (1 = very bad, 5 = very good).
Full Information
NCT ID
NCT04246736
First Posted
December 17, 2019
Last Updated
January 28, 2020
Sponsor
Karolinska Institutet
Collaborators
AFA Insurance
1. Study Identification
Unique Protocol Identification Number
NCT04246736
Brief Title
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 30, 2017 (Actual)
Primary Completion Date
December 13, 2018 (Actual)
Study Completion Date
December 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
AFA Insurance
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
207 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The intervention group received a "Recovery programme" including three group sessions.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group was on a waiting list to receive the intervention after the last follow-up measure (six months after the intervention group's last group session).
Intervention Type
Behavioral
Intervention Name(s)
Bädda för Kvalitet
Intervention Description
A group-administered preventive programme focusing on beneficial strategies for sleep and recuperation, in relation to work related stress and shift work. The intervention was based on knowledge from previous 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. Participants were encouraged to discuss and reflect on personal habits related to sleep and recovery. As homework between sessions, the participants were encouraged to try possibly beneficial strategies for sleep and recuperation. All participants got written material covering the content of the session, during each sessions. In addition, an adapted version of a biomathematical model ("ArturNurse") was used 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.
Primary Outcome Measure Information:
Title
Change in insomnia symptoms (subjective measure)
Description
Insomnia Severity Index (ISI) which consists of 7 questions related to sleep e.g. "How satisfied are you with your current sleep pattern?" (0 = very satisfied, 4 = very dissatisfied). The total score is summarised with a minimum score 0, maximum score 28. Higher scores indicate more sleep problems.
Time Frame
In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Title
Change in sleep quality (subjective measure)
Description
Karolinska Sleep Questionnaire (KSQ) from which a sleep quality index was formed based on four questions e.g. "Have you had problems falling asleep the past month"? etc : Minimum score 1, maximum score 6. Lower scores indicate worse sleep quality.
Time Frame
In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Title
Change in Dysfunctional beliefs and attitudes about sleep (subjective measure)
Description
Dysfunctional Beliefs and Attitudes about Sleep (DBAS) consists of 10 statements regarding beliefs and attitudes to sleep e.g. "I am concerned that chronic insomnia may have serious consequences on my physical health"; "When I have trouble sleeping, I should stay in bed and try harder" (strongly agree - strongly disagree): Minimum score 0, maximum score 10. Higher scores indicate more dysfunctional sleep-related cognitions.
Time Frame
In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Title
Change in sleep (subjective measure)
Description
Karolinska Sleep Diary (KSD). KSD includes bedtime; time of awakening; sleep latency (the time it takes to fall asleep); feelings of worry and stress at bedtime (1 very worried/aroused - 5 very calm/relaxed); and the following questions: Did you have difficulties falling asleep? (1 = very; 5 = not at all) How did you sleep? (1 = very badly; 5 = very good); Did you have a restless sleep? (1 = very much so; 5 = not at all); Did you wake up very early without being able to fall asleep? (1 = much too early; 5 = no). These four latter questions constitutes a sleep quality index, minimum score 1, maximum score 5: Lower scores indicate worse sleep quality.
Time Frame
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.
Title
Change in satisfaction with sleep
Description
Self-rated sufficient sleep (5=very insufficient 1=fully sufficient)
Time Frame
In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Title
Change in subjective sleep quality
Description
Self-rated general sleep quality (1=very good 5=very bad).
Time Frame
In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Title
Change in sleep (objective measures)
Description
Actigraphy (wrist-watch). Measuring of movements during sleep through a sensitive accelerometer in the wrist-watch. The value, which is described as the amount of movements per minute, is saved in the memory of the actigraph. Preprogrammed algorithms make it possible to classify if the participant has slept or not. Measured seven nights at baseline and seven nights at follow up. Example of measures:
Actual sleep time: The total time spent in sleep according to the epoch-by-epoch wake/sleep categorisation.
Actual sleep %: Actual sleep time expressed as a percentage of the assumed sleep time.
Actual wake time: The total time spent in wake according to the epoch-by-epoch wake/sleep categorisation.
Wake bouts: The number of contiguous sections categorised as wake in the epoch-by- epoch wake/sleep categorisation.
Sleep fragmentation: The sum of the "Mobile time (%)" and the "Immobile bouts <=1min (%)". This is an indication of the degree of fragmentation.
Time Frame
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.
Title
Change in work home interference (subjective measures)
Description
Work-Home Interference (WHI) measured with four items: "I come home from work too tired to do things I would like to do."; "My job makes it difficult to maintain the kind of personal life I would like."; "I often neglect my personal needs because of the demands of my work."; "My personal life suffers because of my work." Rated on a 5-graded scale ranging from 1=not at all to 5=almost always.
Time Frame
In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Title
Change in fatigue and recuperation (subjective measures)
Description
Single items (self-ratings): Frequency of recovery behaviours (e.g. micro breaks (1 = every shift, 5 = Never); routine for winding down before bedtime (1 = never, 5 = Always); Satisfaction regarding rest and recuperation during spare time (1 = fully sufficient, 5 = no, far from sufficient); Use of strategies for optimizing sleep and recuperation (1 = never, 5= always); General satisfaction with spare time (1 = very good, 5 = very bad); Use of free time before evening shifts (1 = never, 5 = always); Frequency of breaks during work shifts (1 = every shift, 5= never).
Time Frame
In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Title
Change in diurnal levels of sleepiness (subjective measures)
Description
Karolinska Sleepiness Scale (KSS): A nine-graded scale with values ranging from 1=very alert to 9=very sleepy, fighting sleep. Measured every third hour during wake time seven days at baseline and seven days at follow up.
Time Frame
In order to detect change measures were made at baseline and 4 weeks after the intervention.
Title
Change in symptoms of sleepiness and fatigue (subjective measures)
Description
Single items measuring symptoms of fatigue e.g. "sustained fatigue", "unfocused" and "engaged", on a five-graded scale ranging from 1=not at all, and 5=very much. Measured seven days at baseline and seven days at follow up.
Time Frame
In order to detect change measures were made at baseline to 4 weeks after the intervention.
Title
Change in burnout (subjective measure)
Description
Shirom-Melamed Burnout Questionnaire (SMBQ): Minimum score 1, maximum score 7. Higher scores indicate more burnout.
Time Frame
In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Title
Change in perceived stress (subjective measure)
Description
Perceived Stress Scale (PSS-10) which consists of 10 statements e.g.. "In the last month, how often have you felt nervous and "stressed"; "In the last month, how often have you found that you could not cope with all the things that you had to do"? etc: Answers on 0 = never, 4 = very often. These are summarised. Minimum score 0, maximum score 40. Higher scores indicate more stress.
Time Frame
In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Title
Change in stress and energy (subjective measures)
Description
Stress-Energy rating questionnaire: Minimum score 0, maximum score 5. Higher scores indicate more stress and more energy.
Time Frame
In order to detect change measures were made at baseline and 4 weeks after the intervention.
Title
Change in stress symptoms (subjective measures)
Description
Self-ratings of stress symptoms/absence of stress symptoms (single items): "Tense"; "Irritated"; "Exhausted"; "Hard to disconnect from thoughts of work during spare time"; "Emotional burden"; "Relaxed/calm" on a scale ranging from 1=not at all, and 5=very much. Measured every day during seven days at baseline and seven days at follow up.
Time Frame
In order to detect change measures were made at baseline and 4 weeks after the intervention.
Title
Change in diurnal levels of stress (subjective measures)
Description
Self-rated stress scale for repeated measurement, measured one a nine-graded scale with values ranging from 1=very low stress to 9=very high stress. Measured every third hour during wake time seven days at baseline and seven days at follow up.
Time Frame
In order to detect change measures were made at baseline and 4 weeks after the intervention.
Title
Change in stress (objective measures)
Description
Hair cortisol based on 2 cm segments (pg/mg)
Time Frame
In order to detect change measures were made at baseline and 4 weeks after the intervention.
Title
Change in somatic symptoms
Description
Somatic Symptoms Scale-8 (SSS-8): Minimum score 0, maximum score 32. Higher scores indicate higher somatic symptom burden.
Time Frame
In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Title
Change in health
Description
Single items: Self-rated health on a scale ranging from 1=very good to 7=very bad. Self-rated use of medical drugs the past three months (frequency as 1 = never, 5 = always), coffee consumption during a work day (1 = none, 5 = 7 cups or more); how often do you do 30 minutes of physical exercise (1 = never, 5 = 3 times of more/week).
Time Frame
In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Title
Change in psychological health
Description
Single items (self-ratings): How often have you during the past 7 days felt "depressed"; "stated"; "sad"; "worried"; "nervous"; "unsure" on a scale ranging from 0=not at all to 5=very much.
Time Frame
In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Title
Change in self rated health
Description
Self-rated health on a scale ranging from 1=very good to 7=very bad. Measured daily during seven days at baseline and seven days at follow-up.
Time Frame
In order to detect change measures were made at baseline and 4 weeks after the intervention.
Title
Change in performance and cognitive symptoms (subjective measures)
Description
Ratings (single items): Self-rated work performance through the following items: During the past month how often have you during you work .... "in risk of mistakes"; "found it hard to make decisions"; "been present during interaction with others"; "had to make corrections or double-check work tasks" (1 = never, 5 = Always). Sub-indices from SMBQ (described above) will also be used as measures of cognitive symptoms.
Time Frame
In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Title
Change in performance and cognitive symptoms (subjective measures)
Description
Self-ratings (single items) of how well the participant managed to (at work) make decisions; keep things in their head; keep track of the overall picture; perform tasks in a safe way; being present during interaction with others. Rated on a 5-graded scale ranging from 1=very well to 5=very badly.
Time Frame
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.
Title
Change in performance, arithmetic ability (objective measures)
Description
Cognitive tests measuring executive functioning, performed on the participant's mobile phone. In the arithmetic ability task, the participant is presented with simple arithmetical addition questions and required to calculate the answer and type it into the phone. New questions are presented until the time is running out (duration 2 minutes). Performance is measured in terms of total score (correct responses during 2 minutes) and the speed of correct responses (in ms).
Time Frame
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).
Title
Change in performance, episodic memory (objective measures)
Description
Cognitive tests measuring executive functioning, performed on the participant's mobile phone. In the episodic memory task, participants are presented with a list of 12 words for 12 seconds, which they are asked to remember. A fixation cross then appears for 5 seconds. Following this, participants are shown a list of 24 words, which contains the original 12 words, and an additional 12 dummy words, and are asked whether each word was previously shown (yes/no). The task is performed twice. Performance is assessed as percentage correct.
Time Frame
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 Outcome Measure Information:
Title
Changes in work measures
Description
Single items (self-ratings): Satisfaction with work; Work environment ratings (e.g. tempo, emotional demands, control over work tasks, support, engagement, frequency of tasks in conflict with personal values, quality of cooperation with coworkers); Self-rated patient safety at workplace; Work time control (WTC) where the respondents rate on a five graded scale (1=very little to 5=very much) how much they are able to influence the following aspects of their working times: length of a work shift, the starting and ending times of a work shift, the taking of breaks during the work shift, the scheduling of work shifts, the scheduling of vacations and days off, and the handling of private matters during the workday
Time Frame
Baseline, 4 weeks after the intervention and 6 months after the intervention.
Title
Changes in working hours
Description
Single items (self-ratings):
Frequency (per month) of overtime work, night shifts and quick returns (less than 11 hours between shifts). Self-rated experiences of problems regarding these different type of shifts/shift combinations (yes/no), type of shift schedule, satisfaction with working hours (1 = very bad, 5 = very good).
Time Frame
Baseline, 4 weeks after the intervention and 6 months after the intervention.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Newly graduated nurse in the first year of employment
No Exclusion Criteria.
Facility Information:
Facility Name
Sahlgrenska Universitetssjukhuset
City
Göteborg
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset
City
Huddinge
Country
Sweden
Facility Name
Universitetssjukhuset
City
Linköping
Country
Sweden
Facility Name
Lasarettet Ljungby
City
Ljungby
Country
Sweden
Facility Name
Vrinnevisjukhuset
City
Norrköping
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset
City
Solna
Country
Sweden
Facility Name
Centrallasarettet
City
Växjö
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35074887
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.
Results Reference
derived
Learn more about this trial
A Proactive Intervention Promoting Strategies for Sleep and Recovery in Nurses
We'll reach out to this number within 24 hrs