Sleep QualityNCT05185466
Self Management Programme on the Sustained Attention and Sleep Quality of the Nurses
A study testing Nurse-Supported Self Management Programme in people with Sleep Quality and Attention, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effect of the nurse-supported self-management program on the sustained attention and sleep quality of night shift nurses. The self-management program consists of training and incentives for night shift nurses to gain healthy eating habits and improve their sleep health. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, Attention, Nurses
- What is being tested?
- Nurse-Supported Self Management Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Oct 2021to 7 Mar 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nurses working in shifts
- Those between the ages of 18-65
- Those who agree to participate in the study.
Who cannot join
- Pregnant and having suspicion of pregnancy
- Having vision and hearing problems
- Having diagnosed sleep disorder
- Having a chronic disease that will prevent participation in the study
- Having a diagnosed mental health problem
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Nurse-Supported Self Management Programme on the Sustained Attention and Sleep Quality of the Nurses Working at Night Shift
The aim of this study is to examine the effect of the nurse-supported self-management program on the sustained attention and sleep quality of night shift nurses. The self-management program consists of training and incentives for night shift nurses to gain healthy eating habits and improve their sleep health.
- Conditions
- Sleep Quality, Attention, Nurses
- Being tested
- Nurse-Supported Self Management Programme
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Supported Self Management ProgrammeBehavioural
Training and incentives to improve nutrition habits and sleep health.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Experimental Group Receives: Behavioral: Nurse-Supported Self Management Programme |
| Control Group | No intervention | Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Attention
Psychomotor Vigilance Test
Measured: First Month
Sleep Quality
Pittsburgh Sleep Quality Index (PSQI)
Measured: First Month
Sleepiness
Epworth Sleepiness Scale
Measured: First Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start13 Oct 2021
- Primary completion7 Jan 2022 (estimated)
- Study completion7 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Çolak, Uskudar University
- Investigators
- Merve Çolak, MSc, Principal investigator, T.C. Üsküdar Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185466
- Sponsor's protocol ID
- 61351342/Ocak 2021-88
- Status last verified
- Jan 2022
- First submitted
- 22 Dec 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Colak M, Esin MN. The Effect of Nurse-Led Self-Management Program on Psychomotor Vigilance and Sleep of Nurses Working Night Shifts: A Randomised Controlled Trial. Int J Nurs Pract. 2025 Dec;31(6):e70076. doi: 10.1111/ijn.70076.
PubMed 41188198
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nurse-Supported Self Management Programme on the Sustained Attention and Sleep Quality of the Nurses Working at Night Shift
- ClinicalTrials.gov ID
- NCT05185466
- Acronym / sponsor ID
- 61351342/Ocak 2021-88
- Conditions
- Sleep Quality, Attention, Nurses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 7 Jan 2022 (estimated)
- Study completion
- 7 Mar 2022 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to examine the effect of the nurse-supported self-management program on the sustained attention and sleep quality of night shift nurses. The self-management program consists of training and incentives for night shift nurses to gain healthy eating habits and improve their sleep health.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Nurse-Supported Self Management ProgrammeExperimental Group |
| Control Group | No intervention | –Control Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Nurses working in shifts
- Those between the ages of 18-65
- Those who agree to participate in the study.
Key exclusion criteria (5 listed)
- Pregnant and having suspicion of pregnancy
- Having vision and hearing problems
- Having diagnosed sleep disorder
- Having a chronic disease that will prevent participation in the study
- Having a diagnosed mental health problem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-Supported Self Management ProgrammeTraining and incentives to improve nutrition habits and sleep health. | Behavioural | Experimental Group |
Primary outcome
Sustained Attention
Time frame: First Month
Psychomotor Vigilance Test
Sleep Quality
Time frame: First Month
Pittsburgh Sleep Quality Index (PSQI)
Sleepiness
Time frame: First Month
Epworth Sleepiness Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Derived from this study: PubMed 41188198Colak M, Esin MN. The Effect of Nurse-Led Self-Management Program on Psychomotor Vigilance and Sleep of Nurses Working Night Shifts: A Randomised Controlled Trial. Int J Nurs Pract. 2025 Dec;31(6):e70076. doi: 10.1111/ijn.70076.
- Individual participant dataSharing planned: No
Related trials for Sleep Quality
Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Insomnia Chronic, Hypnotics and Sedatives
Not yet recruiting
CannaRiver CBD Calm for Anxiety, Sleep, and Well-Being in Adults With Generalized Anxiety Disorder
Generalized Anxiety Disorder
Recruiting
Hemodynamics After Resistance Training
Perimenopause
Not yet recruitingPhase 2
Lemborexant on Perioperative Sleep Quality in Patients With Brain Tumor Undergoing Surgery
Brain Neoplasms, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 2
Lemborexant on Perioperative Sleep Quality in Patients With Parkinson's Disease Undergoing Deep Brain Stimulation
Parkinson Disease (PD), Sleep Initiation and Maintenance Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merve Çolak, MSc principal investigator
T.C. Üsküdar Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Supported Self Management Programme in people with Sleep Quality and Attention, run by Uskudar University at 1 site in Turkey (Türkiye).
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 5 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: status not confirmed, as of the sponsor's last update on 19 Jan 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
Sustained Attention (time frame: First Month). The study lists 3 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 NCT05185466, which also lists 1 linked publication.
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 19 Jan 2022.