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

NCT02612636 | Completed DMC

• 1 other identifier: IRB0000871100
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Sleep quality .

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

  four days

Secondary Outcomes (3)

• Urine Melatonin

  four days

• Cortisol level

  four days

• Delirium assessment

  four days

Study Arms (2)

ear plug and eye mask

ACTIVE COMPARATOR

* 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.

Other: ear plug; Other: eye mask

control

NO INTERVENTION

The researcher will assess and observe the patients who are receiving the routine hospital nursing care during the four nights.

Interventions

ear plug OTHER

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

Also known as: eastnova ear plug

ear plug and eye mask

eye mask OTHER

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

Also known as: Sleeping mask

ear plug and eye mask

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Head injury.
• Psychiatric disease.
• Shocked patients

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine

Asyut, 74111, Egypt

Location

MeSH Terms

Conditions

Delirium

Interventions

Ear Protective Devices

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Protective Clothing; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• sayed abd elshafy

  associate professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: November 24, 2015
• Study Start: November 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: June 7, 2017

Record last verified: 2017-06

Locations

EG (1)