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

NCT05451186 | Completed

• 1 other identifier: 8991
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care Unit Syndrome

Keywords

Intensive Care Unit; Headphones; Sleep bands; Sleep

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

• Visual Analog Scale (Fear)

  4. days

• Visual Analog Scale (Anxiety)

  4. days

• Vital Signs Follow-up Form

  4. days

• The Richards-Campbell Sleep Questionnaire

  4. days

Study Arms (2)

Eye patch and headphones

EXPERIMENTAL

Eye patch and headphones

Other: Eye patch and headphones

Control group

NO INTERVENTION

Routine maintenance will be applied

Interventions

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.

Eye patch and headphones

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Sabahattin Zaim University: lead

Study Sites (1)

Istanbul Sabahattin Zaim University, Faculty of Health Sciences

Istanbul, 34340, Turkey (Türkiye)

Location

Related 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.

  PMID: 35227973 RESULT

Study Officials

• Zülfünaz Özer

  Istanbul Sabahattin Zaim University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Experimental group and control group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

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

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 11, 2022
• Study Start: June 20, 2022
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)