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

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.

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Other: ear plug; Other: eye mask

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 74111
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: ear plug; The patients will receive the intervention (ear plug) in the third night (N3) from 9 pm to 6 am.; Other Names: eastnova ear plug; Other: eye mask; The patients will receive the intervention (eye mask) in the second night (N2) from 9 pm to 6 am.; Other Names: Sleeping mask
No Intervention: control; The researcher will assess and observe the patients who are receiving the routine hospital nursing care during the four nights.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: sayed abd elshafy, Associate professor

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: November 16, 2015
• First Submitted That Met QC Criteria: November 23, 2015
• First Posted (Estimate): November 24, 2015

Study Record Updates

• Last Update Posted (Actual): June 7, 2017
• Last Update Submitted That Met QC Criteria: June 6, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Sleep; Delirium; Mechanical ventilation; Ear Plug; Eye Mask
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: IRB0000871100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED