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

NCT ID: NCT02612636

Last Updated: 2017-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-05-31

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).

Conditions

Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

ear plug and 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.

Group Type: ACTIVE_COMPARATOR

ear plug

Intervention Type: OTHER

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

eye mask

Intervention Type: OTHER

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

control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ear plug

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

Intervention Type: OTHER

eye mask

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

Intervention Type: OTHER

Other Intervention Names

eastnova ear plug; Sleeping mask

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Sayed Kaoud Abd-Elshafy

Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

sayed abd elshafy

Role: PRINCIPAL_INVESTIGATOR

associate professor

Locations

Faculty of Medicine

Asyut, , Egypt

Countries

Egypt

Other Identifiers

IRB0000871100

Identifier Type: -

Identifier Source: org_study_id