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

Intensive Care Unit Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05451186
• Other study ID #: 8991
• Status: Completed
• Phase: N/A
• Start date: June 20, 2022
• Est. completion date: November 15, 2022

Study information

• Verified date: February 2023
• Source: Istanbul Sabahattin Zaim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intensive Care Unit Syndrome

Intervention

Other:
• Eye 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.

Locations

Country	Name	City	State
Turkey	Istanbul Sabahattin Zaim University, Faculty of Health Sciences	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Sabahattin Zaim University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Kasapoglu ES, Enc N. Role of multicomponent non-pharmacological nursing interventions on delirium prevention: A randomized controlled study. Geriatr Nurs. 2022 Mar-Apr;44:207-214. doi: 10.1016/j.gerinurse.2022.02.015. Epub 2022 Feb 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (Fear)	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.	the first day after receiving randomisation
Primary	Visual Analog Scale (Anxiety)	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.	the first day after receiving randomisation
Primary	Vital Signs Follow-up Form	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.	the first day after receiving randomisation
Primary	The Richards-Campbell Sleep Questionnaire	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.	the first day after receiving randomisation
Secondary	Visual Analog Scale (Fear)	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.	4. days
Secondary	Visual Analog Scale (Anxiety)	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.	4. days
Secondary	Vital Signs Follow-up Form	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. days
Secondary	The Richards-Campbell Sleep Questionnaire	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.	4. days