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The Eye Patch and Headset on Sleep Quality, Anxiety, Fear and Vital Signs

The Effect of Eye Patch and Headset on Sleep Quality, Anxiety, Fear and Vital Signs in Intensive Care Patients: A Randomized Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05451186
Enrollment
60
Registered
2022-07-11
Start date
2022-06-20
Completion date
2022-11-15
Last updated
2023-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Unit Syndrome

Keywords

Intensive Care Unit, Headphones, Sleep bands, Sleep

Brief summary

This study was planned to investigate the effects of eye patch and headphones on sleep quality, anxiety, fear and vital signs in coronary intensive care unit patients.

Detailed description

In intensive care units, it can be much easier to change the environment perception of patients with simple tools such as headphones and sleep bands, rather than changing the environment of the patients. The use of sleep bands and headphones, which are non-pharmacological methods, can reduce sleep deprivation by changing the environmental perception of the patients.

Interventions

OTHEREye patch and headphones

Patients in the experimental group will be asked to use an eye mask and earplugs from 22:30 to 6:30 in the morning on the 1st, 2nd and 3rd nights.

Sponsors

Istanbul Sabahattin Zaim University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Masking description

Experimental group and control group

Intervention model description

This research is a single-blind study with a pretest-posttest randomized control group.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Being 18 years or older, * New York Heart Association (NYHA) functional class II and III, * Not having received any general anaesthesia for the previous 24 hours, * Not having received any sedative medications or opioids for the past 24 hours, * Not having a verbal communication disability (hearing and speaking), * Absence of pain, * Not having a previously diagnosed sleep disorder, * Not having psychiatric problems, * Not having a cognitive problem, * Being healthy enough to put on and take off earplugs independently, in addition to wearing an eye mask and removing it when necessary, and continuing to be hospitalized for at least three days.

Exclusion criteria

* Diagnosed with delirium (Intensive care delirium screening checklist \>=5), * Unconscious (Glasgow coma scale\<13), * Presence of additional chronic diseases, * Having consumed coffee, alcohol and hypnotic drugs at least 12 hours before the study, * Patients whose condition suddenly worsened, * Those who cannot use earplugs and eye masks effectively at night, * Those who voluntarily withdrew from the study and were transferred from the intensive care unit.

Design outcomes

Primary

MeasureTime frameDescription
The Richards-Campbell Sleep Questionnairethe first day after receiving randomisationThis brief five-item questionnaire was used to evaluate perceived sleep depth, sleep latency (time to fall asleep), number of awakenings, efficiency (percentage of time awake), and sleep quality. It also includes a sixth item evaluating perceived night-time noise. Each item is evaluated on a scale of 0-100 with a visual analogue scale technique. A score of 0-25 indicates very poor quality sleep, whereas a score of 76-100 indicates very good sleep quality.
Visual Analog Scale (Fear)the first day after receiving randomisationPatients are asked to show the severity of their fear on a 10 cm long vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.
Visual Analog Scale (Anxiety)the first day after receiving randomisationPatients are asked to show the severity of their anxiety on a 10 cm long vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.
Vital Signs Follow-up Formthe first day after receiving randomisationThis form was created by the researcher in order to record the systolic-diastolic blood pressure, and heart rate (pulse), values of the patient who was applied an eye patch or earphone at night.

Secondary

MeasureTime frameDescription
Visual Analog Scale (Fear)4. daysPatients are asked to show the severity of their fear on a 10 cm long vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.
Visual Analog Scale (Anxiety)4. daysPatients are asked to show the severity of their anxiety on a 10 cm long vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.
Vital Signs Follow-up Form4. daysThis form was created by the researcher in order to record the systolic-diastolic blood pressure, and heart rate (pulse), values of the patient who was applied an eye patch or earphone at night.
The Richards-Campbell Sleep Questionnaire4. daysThis brief five-item questionnaire was used to evaluate perceived sleep depth, sleep latency (time to fall asleep), number of awakenings, efficiency (percentage of time awake), and sleep quality. It also includes a sixth item evaluating perceived night-time noise. Each item is evaluated on a scale of 0-100 with a visual analogue scale technique. A score of 0-25 indicates very poor quality sleep, whereas a score of 76-100 indicates very good sleep quality.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026