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Completed

NCT Number: NCT05451186

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

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.

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Key information

Conditions

Intensive Care Unit Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Sabahattin Zaim University, Faculty of Health Sciences

Istanbul, 34340, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eye patch and headphones

Other

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.

Primary outcomes

  1. Visual Analog Scale (Fear)

    Time frame: the first day after receiving randomisation

    Patients 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.

  2. Visual Analog Scale (Anxiety)

    Time frame: the first day after receiving randomisation

    Patients 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.

  3. Vital Signs Follow-up Form

    Time frame: the first day after receiving randomisation

    This 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.

  4. The Richards-Campbell Sleep Questionnaire

    Time frame: the first day after receiving randomisation

    This 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.

Secondary outcomes

  1. Visual Analog Scale (Fear)

    Time frame: 4. days

    Patients 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.

  2. Visual Analog Scale (Anxiety)

    Time frame: 4. days

    Patients 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.

  3. Vital Signs Follow-up Form

    Time frame: 4. days

    This 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.

  4. The Richards-Campbell Sleep Questionnaire

    Time frame: 4. days

    This 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.

Sponsors and collaborators

Lead sponsor

Istanbul Sabahattin Zaim University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 11, 2022
Registry last updated
Feb 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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