Clinical trial NCT05451186: The Eye Patch and Headset on Sleep Quality, Anxiety, Fear and Vital Signs
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care Unit Syndrome
Keywords: Intensive Care Unit
Headphones
Sleep bands
Sleep
Lead sponsor: Istanbul Sabahattin Zaim University
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This research is a single-blind study with a pretest-posttest randomized control group.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analog Scale (Fear)
timeFrame: the first day after receiving randomisation
measure: Visual Analog Scale (Anxiety)
timeFrame: the first day after receiving randomisation
measure: Vital Signs Follow-up Form
timeFrame: the first day after receiving randomisation
measure: The Richards-Campbell Sleep Questionnaire
timeFrame: the first day after receiving randomisation
Secondary outcomes:
measure: Visual Analog Scale (Fear)
timeFrame: 4. days
measure: Visual Analog Scale (Anxiety)
timeFrame: 4. days
measure: Vital Signs Follow-up Form
timeFrame: 4. days
measure: The Richards-Campbell Sleep Questionnaire
timeFrame: 4. days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Sabahattin Zaim University, Faculty of Health Sciences
Study officials:
affiliation: Istanbul Sabahattin Zaim University
name: Zülfünaz Özer
role: STUDY_DIRECTOR
References:
citation: 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.