NCT07755280

Brief Summary

Sleep quality is a complex and multidimensional phenomenon shaped by the interaction of patient characteristics, symptom burden, and environmental factors specific to the intensive care unit environment. Despite this multidimensional nature, studies identifying predictors of sleep quality in intensive care units after cardiac surgery are limited.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
157

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
Last Updated

August 10, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

August 5, 2026

Last Update Submit

August 5, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Pain

    Assessed wit Visual Analog Scale. his scale is a unidimensional, self-report instrument measuring 10 cm in length. The lower end corresponds to a score of 0, labeled 'no pain,' while the upper end corresponds to a score of 10, labeled 'unbearable pain.' Higher scores on the scale indicate greater severity of pain as reported by the patient.

    At least 24 hours after admission to the intensive care unit

  • Sleep quality

    Assessed with Richard- Campbell Sleep Questionnaire. he scale consists of 6 items assessing sleep quality, nocturnal sleep depth, frequency of awakening, ambient noise level, time spent awake, and sleep onset latency. Each item is rated on a visual analog scale ranging from 0 to 100. The total score obtained from the scale is divided by the number of items to calculate the scale score. A scale score between 0 and 25 is interpreted as very poor sleep, while a score between 76 and 100 is interpreted as very good sleep.

    At least 24 hours after admission to the intensive care unit

  • Fatigue

    Assessed wit Visual Analog Scale. his scale is a unidimensional, self-report instrument measuring 10 cm in length. The lower end corresponds to a score of 0, labeled 'no fatigue,' while the upper end corresponds to a score of 10, labeled 'unbearable fatigue.' Higher scores on the scale indicate greater severity of fatigue as reported by the patient.

    At least 24 hours after admission to the intensive care unit

  • Environmental Stressors

    Assessed with Intensive Care Unit Environmental Stressors Scale. The scale is of a 4-point Likert type and consists of 42 items. The minimum possible score is 42 and the maximum is 168. Higher scores are interpreted as indicating a greater degree of being affected by environmental stressors.

    At least 24 hours after admission to the intensive care unit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to the cardiovascular intensive care unit after open heart surgery

You may qualify if:

  • ability to understand and speak Turkish,
  • willingness to participate in the study,
  • having spent at least 24 hours in the intensive care unit, and
  • having the cognitive ability to understand and answer questions.

You may not qualify if:

  • having taken narcotic or sedative drugs within the last 48 hours,
  • having a history of chronic diseases that can cause sleep problems such as Chronic Obstructive Pulmonary Disease or sleep apnea,
  • having a psychiatric illness diagnosed by a physician,
  • having a visual or hearing impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydın Adnan Menderes University

Aydin, Zafer Mahallesi, 09010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Research Assisstant (Principal Investigator)

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 10, 2026

Study Start

September 15, 2025

Primary Completion

March 15, 2026

Study Completion

May 15, 2026

Last Updated

August 10, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Shared Documents
STUDY PROTOCOL
Time Frame
12 months after publication

Locations