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

A

Assiut University

Status

Completed

Conditions

Sleep

Treatments

Other: ear plug
Other: eye mask

Study type

Interventional

Funder types

Other

Identifiers

NCT02612636
IRB0000871100

Details and patient eligibility

About

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.

Full 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).

Enrollment

60 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

ear plug and eye mask
Active Comparator group
Description:
* The patients will not receive the intervention in the first night (N1) 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. * 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 and ear plug) in the fourth night (N4) from 9 pm to 6 am.
Treatment:
Other: eye mask
Other: ear plug
control
No Intervention group
Description:
The researcher will assess and observe the patients who are receiving the routine hospital nursing care during the four nights.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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