NCT05185466

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2021

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2022

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

December 22, 2021

Last Update Submit

January 15, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Sustained Attention

    Psychomotor Vigilance Test

    First Month

  • Sleep Quality

    Pittsburgh Sleep Quality Index (PSQI)

    First Month

  • Sleepiness

    Epworth Sleepiness Scale

    First Month

Study Arms (2)

Experimental Group

EXPERIMENTAL

Experimental Group

Behavioral: Nurse-Supported Self Management Programme

Control Group

NO INTERVENTION

Control Group

Interventions

Training and incentives to improve nutrition habits and sleep health.

Experimental Group

Eligibility Criteria

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

You may qualify if:

  • Nurses working in shifts
  • Those between the ages of 18-65
  • Those who agree to participate in the study.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul / Turkey

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Merve Çolak, MSc

    T.C. Üsküdar Üniversitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Assistant

Study Record Dates

First Submitted

December 22, 2021

First Posted

January 11, 2022

Study Start

October 13, 2021

Primary Completion

January 7, 2022

Study Completion

March 7, 2022

Last Updated

January 19, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations