Brief Summary

The research was carried out in randomized controlled experimental type in order to determine the effect of light in ICU on patients' sleep quality and physiological parameters. The cases were assigned to the experimental and control groups according to the simple randomization method. The research universe; Between May 2019 and December 2019, sick individuals who were admitted to the 5 isolation rooms in the Reanimation Intensive Care clinic in the education and research hospital in Istanbul were formed. The research sample is; As a result of the power made for the study to be experimentally designed; a total of 148, with a minimum of 74 for each group. In collecting data; Patient Information Form, Numerical Pain Rating Scale, Richards Campbell Sleep Scale, Glaskow Coma Scale, Richmond Agitation Sedation Scale, Bedside Monitors were used to measure physiological parameters. The data obtained as a result of the research were made using the package program named SPSS (IBM SPSS Statistics 24).

Trial Health

On Track

Trial Health Score

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

Enrollment

148

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started May 2019

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

8 months study duration

Study Start

First participant enrolled

May 2, 2019

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2019

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2019

Completed

11 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2020

Completed

1 month until next milestone

First Posted

Study publicly available on registry

December 14, 2020

Completed

Last Updated

December 16, 2020

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

November 11, 2020

Last Update Submit

December 11, 2020

Conditions

Sleep Light

Keywords

Sleep QualityLightIntensive Care Unit

Outcome Measures

Primary Outcomes (1)

Change in sleep time with light intervention in experimental and control groups in the intensive care unit
A recirculating lighting system was installed in the isolation room for the experimental group in line with evidence-based design principles. Light fixture 120 cm from the floor. high and light shining up. The system was set up to operate at varying levels of 9 lights, illumination for 24 hours. No application other than the standard lighting system of the ICU was applied to the individuals in the control group. Actiwatch device was placed on the arm of the sick individuals. Thanks to this device, the sleep time of the individuals was recorded.
After the patient was admitted to the intensive care unit, 48 hours of sleep time was recorded.

Secondary Outcomes (4)

The effect of light on the patient's systolic and diastolic blood pressure in the experimental and control groups in the intensive care unit.
The systolic and diastolic blood pressure of the patient who was admitted to the intensive care unit was recorded for 48 hours.
The effect of light on patient's heart rate in intensive care unit in experimental and control groups.
The heart rate of the patient, who was admitted to the intensive care unit, was recorded for 48 hours.
The effect of light on patient's respiratory rate in intensive care unit in experimental and control groups.
The respiration of the patient who was admitted to intensive care unit was recorded for 48 hours.
The effect of light on the patient's body temperature in the intensive care unit in the experimental and control groups.
The body temperature of the patient who was admitted to intensive care unit was recorded for 48 hours.

Study Arms (8)

Individual Characteristics of the Individuals in the Experimental and Control Groups

ACTIVE COMPARATOR

The personal characteristics of the individuals included in the study were examined.

Other: Comparison of the personal characteristics of the experimental and control groups

Disease Characteristics of the Individuals in Experimental and Control Groups

ACTIVE COMPARATOR

The intensive care experience of the individuals included in the study, their status of receiving respiratory support, and the reason for staying in the intensive care unit were explained.

Other: Comparison of the personal characteristics of the experimental and control groups

Distribution of Findings Regarding Sleep Activity of the Individuals in Both Groups

ACTIVE COMPARATOR

The personal characteristics of the individuals in the experimental and control groups regarding sleep were examined.

Other: Comparison of the personal characteristics of the experimental and control groups

Comparison of the Individuals in the experimental and control groups after 24 hours of sleep

ACTIVE COMPARATOR

The effect of light after 24 hours in the experimental and control groups of individuals hospitalized in the intensive care unit was examined.