Skip to content

The Effect of Ear Plug and Eye Mask on Sleeping Quality in Critically Ill Patients

The Effect of Ear Plug and Eye Mask on Sleeping Quality in Critically Ill Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02612636
Acronym
sayed
Enrollment
60
Registered
2015-11-24
Start date
2015-11-30
Completion date
2017-05-31
Last updated
2017-06-07

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

Conditions

Sleep

Keywords

Delirium, Ear Plug, Eye Mask, Mechanical ventilation, Sleep

Brief summary

Sleep is a complex physiologic and behavioral process essential for rest, repair, well-being, and survival. Sleep is defined as a periodic, reversible state of cognitive and sensory disengagement from the external environment. Critically ill patients experience poor sleep quality. Surveys of ICU survivors have shown that sleep disruption, pain and intubation for mechanical ventilation are the major sources of anxiety and stress during the ICU stay. Many physiological, psychological and environmental factors contribute to the incidence of sleep disruption for the ICU patients. The primary physiologic factors documented in the literature are pain, medications and illness.The primary psychological factors documented in the literature are stress and worry. Environmental factors include noise, patient care activities and therapeutic modalities as mechanical ventilation. Our research aim will be the impact of effective interventions like use of ear plugs and eye mask on decreasing light exposure and promoting sleep in ICU patients.

Detailed description

50 patients in the age range 18- 60 years admitted to ICU of Assiut university hospitals will be randomly allocated into into two groups (control group and intervention group).

Interventions

The patients will receive the intervention (ear plug) in the third night (N3) from 9 pm to 6 am.

The patients will receive the intervention (eye mask) in the second night (N2) from 9 pm to 6 am.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Age \>18 years old. * Mechanically ventilated patient. * Conscious patient. * No hearing problems. * No eye disease. * Not receiving narcotic drugs five to six hours before sleep time at night. * No underlying disease that is affecting sleep such as rheumatoid arthritis and migraine.

Exclusion criteria

* Head injury. * Psychiatric disease. * Shocked patients

Design outcomes

Primary

MeasureTime frameDescription
Sleep quality .four daysto assess sleep quality by using quality of sleep questionnaire or the Richards-Campbell Sleep Questionnaire (RCSQ) (measured by Units on a Scale)

Secondary

MeasureTime frameDescription
Urine Melatoninfour daysas urine Melatonin ( pg/mL)
Cortisol levelfour daysstress hormone as cortisol level (nmol/L)
Delirium assessmentfour daysAssessment of delirium by using NEECHAM confusion scale or Nursing delirium screening scale (measured by Units on a Scale)

Countries

Egypt

Outcome results

None listed

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