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OpenTrials
Completed

NCT Number: NCT02612636

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine

Asyut, 74111, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ear plug

Other

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

Other names: eastnova ear plug

Eye mask

Other

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

Other names: Sleeping mask

Primary outcomes

  1. Sleep quality .

    Time frame: four days

    to assess sleep quality by using quality of sleep questionnaire or the Richards-Campbell Sleep Questionnaire (RCSQ) (measured by Units on a Scale)

Secondary outcomes

  1. Urine Melatonin

    Time frame: four days

    as urine Melatonin ( pg/mL)

  2. Cortisol level

    Time frame: four days

    stress hormone as cortisol level (nmol/L)

  3. Delirium assessment

    Time frame: four days

    Assessment of delirium by using NEECHAM confusion scale or Nursing delirium screening scale (measured by Units on a Scale)

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Acronym: sayed

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 24, 2015
Registry last updated
Jun 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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