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

Not Applicable

Completed

• Conditions: Sleep
• Interventions: Other: ear plug; Other: eye mask

• Registration Number: NCT02612636
• Lead Sponsor: Assiut University

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).

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2015-11-23
• Study First Posted: 2015-11-24
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-06
• Last Update Posted: 2017-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ear plug and eye mask	eye mask	* 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.
ear plug and eye mask	ear plug	* 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.

Primary Outcome Measures

Name	Time	Method
Sleep quality .	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 Outcome Measures

Name	Time	Method
Urine Melatonin	four days	as urine Melatonin ( pg/mL)
Cortisol level	four days	stress hormone as cortisol level (nmol/L)
Delirium assessment	four days	Assessment of delirium by using NEECHAM confusion scale or Nursing delirium screening scale (measured by Units on a Scale)

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt