Improving nurses' sleep quality during irregular night shifts: a pilot study testing personalized 'Shift your Sleep' tips
| ISRCTN | ISRCTN84511779 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84511779 |
- Submission date
- 24/11/2023
- Registration date
- 28/11/2023
- Last edited
- 04/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Working shifts, especially irregular night shifts, adversely affects sleep quality, as the circadian rhythm of shift workers, including nurses, is disrupted by nighttime work, impacting their overall sleep. While research has extensively explored the impact of shift work on sleep quality, there has been limited attention given to developing interventions for improving the sleep quality of shift nurses. The effectiveness of the few existing interventions is restricted either due to limited evidence or inconsistent results.
To address this gap and enhance nurses' sleep quality, sleep hygiene strategies could serve as a potential solution. However, it's crucial to recognize that the impact of these strategies may vary from person to person. Therefore, this study aims to personalize sleep hygiene strategies for nurses and assess their effectiveness in improving the sleep quality of nurses working irregular night shifts.
Who can participate?
Nurses who work irregular shifts, including night shifts. To be eligible for the study, the nurse should not have been treated in the past or be under current treatment for sleep problems or diagnosed with conditions such as insomnia. Additionally, the nurse must work night shifts and should not be employed in critical care, such as the intensive care unit. Lastly, the nurse must have an employment contract with the hospital.
What does the study involve?
The "Shift your Sleep!" study involves two phases, baseline and intervention. Each phase is about 30 days. In the baseline phase, the nurse's sleep will be monitored unobtrusively with the Emfit QS sleep monitor, a sleep-monitoring device that can be fastened under a mattress. By the end of the baseline phase, the nurse will be asked to fill out a sleep diary for the past month using Emfit’s data as well as a survey that includes general information and questions regarding sleep quality and sleep hygiene practices.
In the intervention phase, personalized sleep hygiene advice will be provided based on the individual nurse's data from the baseline phase. The advice includes recommendations tailored to the participant's sleep duration, general sleep hygiene practices, and targeted strategies for managing challenges associated with irregular night shifts. The participant will be encouraged to actively experiment with integrating these recommendations into the routine. Further, the nurse will complete assessments, including sleep strategies diaries, weekly plans, and surveys measuring sleep quality and hygiene practices.
What are the possible benefits and risks of participating?
The possible benefits of participating in this study include improving sleep quality, which may improve health overall. Further, there are no possible harms or risks to health that are foreseen for this study. However, it should be noted that participation in this study requires significant commitment and effort from the nurse. The nurse will be reimbursed for the efforts with 100 euros.
Where is the study run from?
Maastricht University and Maastricht University Medical Center+ (Netherlands)
When is the study starting and how long is it expected to run for?
January 2023 to December 2025
Who is funding the study?
This research received no specific grant from any funding agency in the public, commercial or not‐for‐profit sectors, but Al Baha University supported the executive researcher with a scholarship.
Who is the main contact?
Ree Meertens, r.meertens@maastrichtuniversity.nl
Contact information
Public, Principal Investigator
P. Debijeplein 1
Maastricht
6229 HA
Netherlands
 ORCID ID |
0000-0001-8424-9142 |
|---|---|
| Phone | +31 (0)43 3882407 |
| r.meertens@maastrichtuniversity.nl |
Study information
| Study design | An N-of-1 study. The nurse participating in the study will be treated as a control (during the baseline measure) and as an experimental subject (during the advice period). |
|---|---|
| Primary study design | Interventional |
| Secondary study design | N-of-1 study (time series design) |
| Study setting(s) | Home, Hospital |
| Study type | Prevention, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | The effect of personalized ‘Shift your Sleep!’ sleep hygiene recommendations on sleep quality of nurses working irregular night shifts: an N-of-1 pilot study |
| Study acronym | ‘Shift your Sleep!’ |
| Study objectives | 1. Personalized ‘Shift your Sleep!’ sleep hygiene recommendations/advice are effective in improving the sleep quality of nurses working irregular night shifts compared to baseline. 2. It is feasible to implement the ‘Shift your Sleep!’ approach at an individual level for hospital nurses working irregular night shifts. |
| Ethics approval(s) |
Approved 19/07/2023, Faculty of Health, Medicine & Life Sciences (FHML) Research Ethics Committee (Universiteitssingel 40, Maastricht, 6229 ER, Netherlands; +31 (0)43 388 5655; fhml-rec@maastrichtuniversity.nl), ref: FHML-REC/2023/065 |
| Health condition(s) or problem(s) studied | Promoting better sleep quality in hospital nurses working irregular night shifts |
| Intervention | The participant will undergo a baseline measurement period (control period) and an intervention period. The participant will first enter the baseline/control/no treatment condition with 30 days of (unobtrusive) sleep quality measurements. After that, personalized sleep hygiene tips will be provided and the participant will make weekly personal plans for dealing with (night) shifts, also for 30 days. The participant is encouraged to actively experiment with integrating sleep tips into their personal routine. |
| Intervention type | Behavioural |
| Primary outcome measure | Sleep quality, assessed by data filled in a sleep diary obtained from the Emfit device. This data encompasses key factors such as the time of getting into bed, the number of nighttime awakenings, time of awakenings during the sleep period, final awakening time (sleep offset), and time of getting out of bed. These measures are collected both at the end of the baseline phase (30 days) and during the intervention phase (30 days). |
| Secondary outcome measures | 1. Sleep regularity is assessed using sleep diary data obtained from the Emfit, daily during the baseline period (but filled in after the 30 baseline days) and daily during the intervention period (30 days) 2. Sleep hygiene practices are measured daily during the intervention period (30 days) through a sleep hygiene questionnaire, partially based on the sleep hygiene index (SHI) 3. Weekly plan of sleep strategies is assessed using a self-developed questionnaire during the intervention period (every week during 30 days, so four times) 4. Adherence to the previous weekly plan is measured through a self-developed questionnaire regarding the strategies or behaviors implemented in the preceding week during the intervention period (every week during 30 days, so four times) |
| Overall study start date | 01/01/2023 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 67 Years |
| Sex | Both |
| Target number of participants | 1 |
| Total final enrolment | 1 |
| Key inclusion criteria | Nurses who work irregular shifts, including night shifts |
| Key exclusion criteria | Nurses will be excluded if they: 1. Have been treated in the past or are under treatment for sleep problems or diagnosed with such sleep problems as insomnia 2. Do not work night shifts 3. Are classified as a critical care nurse (e.g., work on the intensive care unit) 4. Work as an intern |
| Date of first enrolment | 04/12/2023 |
| Date of final enrolment | 01/07/2025 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Maastricht
6229 HX
Netherlands
Sponsor information
University/education
Prince Mohammad Bin Saud Road
Albaha
65431
Saudi Arabia
| Phone | +966 (0)17-7257700 |
|---|---|
| contact@bu.edu.sa | |
| Website | https://bu.edu.sa |
"ROR" |
https://ror.org/0403jak37 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Al-Baha University, جامعة الباحة, BU
- Location
- Saudi Arabia
Results and Publications
| Intention to publish date | 01/07/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request, Other |
| Publication and dissemination plan | The researchers will try to publish their findings in an international peer-reviewed journal as well as in a PhD thesis. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Ree Meertens, r.meertens@maastrichtuniversity.nl, but only when the participant gives formal permission. |
Editorial Notes
04/08/2025: The following changes were made to the study record:
1. The study design was changed from 'A series of five N-of-1 studies. Each nurse participating in the study will be treated as a control (during the baseline measure) and as an experimental subject (during the advice period)' to 'An N-of-1 study. The nurse participating in the study will be treated as a control (during the baseline measure) and as an experimental subject (during the advice period).'.
2. The target number of participants was changed from 5 to 1.
3. Total final enrolment added.
30/07/2025: A study contact was removed.
01/08/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 01/07/2024 to 01/07/2025.
2. The overall study end date was changed from 01/09/2024 to 31/12/2025.
3. The intention to publish date was changed from 30/12/2024 to 01/07/2026.
28/11/2023: Study's existence confirmed by the Faculty of Health, Medicine & Life Sciences (FHML) Research Ethics Committee.
