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SleepNCT04666142

The Effect of Light on Sleep Quality and Physiological Parameters in Individuals in Intensive Care Unit

A study of Sleep and Light, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 88 years
Conditions the study is for
Sleep, Light
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 May 2019to 28 Dec 2019
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 88 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older,
  • Not having a problem in terms of consciousness and sense organs
  • A score of 9 or above on the Glaskow Coma Scale (GCS),
  • Richmond Agitation-Sedation Scale (RASS) score was determined as -1,0,1.

Who cannot join

  • Be under the age of 18
  • Having a problem in terms of consciousness and sense organs,
  • A GCS score below 9,
  • Receiving inotropic support,
  • Being fully sedated,
  • Having a chronic disease such as chronic heart disease, dementia, psychosis,
  • Identified as having severe brain injury.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Education Research Hospital

    Istanbul

Other trials in Turkey (Türkiye)

About this study

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).

Read the detailed description

Sleep causes temporary, partial and periodic interruption of the organism's interaction with the environment, is a physiological condition that affects many systems. That sleep activity is a vital and important activity for individuals.They emphasized and sleep; the alternating state of inertia and inertia, around the human a situation where they do not respond to the events that took place. initiation and maintenance through the function of many cortical and subcortical brain regions. People sleep on average one third of their lives They spend it. The sleep of a normal adult person consists of night sleep and It lasts an average of 7 to 9 hours, with a sleep time of four to six 90 to 100 minutes. Non-REM (NREM) and REM sleep change cyclically. In the sleep-wake cycle in man, the most basic and determinant is the circadian rhythm. Circadian The rhythm refers to changes in the physiological and biological processes of the organism for about a day. The main center that regulates the circadian rhythm is located in the anterior hypothalamus as a double structure. suprachiasmatic nucleus (SKN). Light is the most important rhythm editor. Other regulators are social and are physical activities. Florence Nightingale and Virgina Henderson in love and day rhythm; defined the patient as two important factors in supporting the health of the individual. In the regulation of the circadian rhythm, the light and dark cycle in the external environment is important. The synthesis and release of melatonin is stimulated in the dark at night, and during the day by the effect of light It is suppressed. N-acetyl transferase (NAT) enzyme is effective in melatonin formation. Melatonin The main task of the hormone is to protect the biological rhythm of the body. In this context; lighting, circadian rhythm and sleep are related.

Health care institutions and especially intensive care units, in terms of physical environment and lighting the patient can affect the circadian rhythm of the individual, change the release of melatonin and as a result can affect sleep patterns and cognitive performance. In our country, in terms of physical environment lighting, it does not support circadian rhythms. As a result, sick individuals in the ICU are asleep The therapeutic effect of sleep because they spend a significant amount of time they need to be awake can not benefit sufficiently. In addition, in the ICU, many There is a factor. These factors are; pain, physical condition, drug therapy, fear of death, environmental noise, pleasant non-smells, invasive interventions, loss of privacy and family disability. In the study of, the greatest stress of the sick individuals in the ICU One of the causes was found to be sleeping problems. In the literature, especially in health care institutions In patients with ICU inpatient, sleep activity has a negative effect on both duration and quality. shows that it is affected In admission to the ICU, when environmental factors are not suitable, the patient especially the sleep activity of the individual is impaired and this process occurs even after the patient is discharged from YBU, can continue. One of the biggest reasons for this; Physical environment and lighting of ICUs in terms of disruption of circadian rhythms of sick individuals. The presence of night light suppresses the level of melatonin, which is normally the highest at night. Melatonin level is accepted as an indicator of circadian rhythm. Artificial lighting is a known factor in the disruption of the circadian rhythm. Sick individuals in the ICU, 24 hours it is exposed to artificial light throughout a cycle. Artificial lighting, health of the sick individual health care to help professionals continue their care and treatment practices It is applied at high levels for 24 hours in institutions such as ICU. Its as a result, daylight is often obscured / eliminated in ICUs and artificial lighting are added. Researches conducted, unnatural night disruption of circadian rhythms with illumination causes health problems related to sleep activity. It is also sufficient and relaxing non-sleep, negatively affects the immune system, wound healing process and cognitive functions of the sick individual. It affects in the same direction, increases the level of stress and delays its recovery. Sick individuals in the ICU are concerned with serious illnesses or injuries and care and treatment. The illness of the symptoms lies. Today, long-term health of an illness or injury in an ICU It is known to cause problems. Some of these problems are sleep problems due to lighting and circadian rhythm disturbances. our Country Study to determine the effect of environmental factors related to lighting on sleep problems in ICU There is. Nurses who continue the care and treatment of sick individuals in ICU, diagnosing problems early, identifying primary nursing diagnoses, existing stressors important role such as reduction, ensuring the necessary environmental regulation to create a therapeutic environment, and they have responsibilities. In this context, this research is based on YBU. to determine the effect of light on sleep quality and physiological parameters in individuals and nursing will be carried out to guide its applications.

Conditions
Sleep, Light
Being tested
Comparison of the personal characteristics of the experimental and control groups, Light applied experimental group, control group treated with standard intensive care lighting
Keywords
Sleep Quality, Light, Intensive Care Unit
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.

  • Comparison of the personal characteristics of the experimental and control groupsOther

    General characteristics of the individuals in the experimental and control groups were compared.

  • Light applied experimental group, control group treated with standard intensive care lightingOther

    According to the results of randomization, the group to which the lighting system will be applied was assigned as "experiment", and the group that will continue standard ICU lighting as "control"

Study groups in NCT04666142
Study groupRoleWhat they receive
Individual Characteristics of the Individuals in the Experimental and Control GroupsActive comparatorThe personal characteristics of the individuals included in the study were examined.
Receives: Other: Comparison of the personal characteristics of the experimental and control groups
Disease Characteristics of the Individuals in Experimental and Control GroupsActive comparatorThe 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.
Receives: Other: Comparison of the personal characteristics of the experimental and control groups
Distribution of Findings Regarding Sleep Activity of the Individuals in Both GroupsActive comparatorThe personal characteristics of the individuals in the experimental and control groups regarding sleep were examined.
Receives: 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 sleepActive comparatorThe effect of light after 24 hours in the experimental and control groups of individuals hospitalized in the intensive care unit was examined.
Receives: Other: Light applied experimental group, control group treated with standard intensive care lighting
Comparison of physiological parameters of individuals in both groups after 24 hoursActive comparatorComparison of the physiological parameters of the individuals in the experimental and control groups 24 hours after their admission to the ICU.
Receives: Other: Light applied experimental group, control group treated with standard intensive care lighting
Comparison of the Sleep Times of the Individuals in Both Groups 48 Hours After Intensive CareActive comparatorThe effect of light after 48 hours in the experimental and control groups of individuals hospitalized in the intensive care unit was examined.
Receives: Other: Light applied experimental group, control group treated with standard intensive care lighting
Comparison of physiological parameters of individuals in both groups after 48 hoursActive comparatorComparison of the physiological parameters of the individuals in the experimental and control groups 48 hours after their admission to the ICU.
Receives: Other: Light applied experimental group, control group treated with standard intensive care lighting
Distribution of Total Sleep Times of the Individuals in the Experimental and Control GroupsActive comparatorThe sleep times of the individuals in both groups were compared
Receives: Other: Light applied experimental group, control group treated with standard intensive care lighting

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: After the patient was admitted to the intensive care unit, 48 hours of sleep time was recorded.

Secondary outcomes (4)
  1. 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 individual was recorded hourly by the investigator through the bedside monitoring system for 48 hours after admission to the ICU.

    Measured: The systolic and diastolic blood pressure of the patient who was admitted to the intensive care unit was recorded for 48 hours.

  2. The effect of light on patient's heart rate in intensive care unit in experimental and control groups.

    The heart rate of the individual was recorded hourly by the researcher through the bedside monitoring system for 48 hours after admission to the ICU.

    Measured: The heart rate of the patient, who was admitted to the intensive care unit, was recorded for 48 hours.

  3. The effect of light on patient's respiratory rate in intensive care unit in experimental and control groups.

    The respiration of the patient was recorded hourly by the researcher through the bedside monitoring system for 48 hours after admission to the ICU.

    Measured: The respiration of the patient who was admitted to intensive care unit was recorded for 48 hours.

  4. 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 was recorded hourly by the researcher through the bedside monitoring system for 48 hours after admission to the ICU.

    Measured: The body temperature of the patient who was admitted to intensive care unit was recorded for 48 hours.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2020
  2. Study start2 May 2019
  3. Primary completion5 Jul 2019
  4. Study completion28 Dec 2019

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
According to the results of randomization, the group to which the lighting system will be applied was assigned as "experiment", and the group that will continue standard ICU lighting as "control"
Masking
Single blind
Who is masked
Participant
Enrolment
148 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04666142
Sponsor's protocol ID
U1111-1260-6250
Other IDs
Kübra pamuk
Status last verified
Nov 2020
First submitted
11 Nov 2020
Last updated
16 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study of Sleep and Light, run by Istanbul University - Cerrahpasa 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 16 Dec 2020. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in sleep time with light intervention in experimental and control groups in the intensive care unit (time frame: After the patient was admitted to the intensive care unit, 48 hours of sleep time was recorded.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 16 Dec 2020.

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