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

Primary Purpose

Sleep

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ear plug
eye mask
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sleep focused on measuring Delirium, Ear Plug, Eye Mask, Mechanical ventilation, Sleep

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

ear plug and eye mask

control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
November 16, 2015
Last Updated
June 6, 2017
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02612636
Brief Title
The Effect of Ear Plug and Eye Mask on Sleeping Quality in Critically Ill Patients
Acronym
sayed
Official Title
The Effect of Ear Plug and Eye Mask on Sleeping Quality in Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep
Keywords
Delirium, Ear Plug, Eye Mask, Mechanical ventilation, Sleep

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ear plug and eye mask
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control
Arm Type
No Intervention
Arm Description
The researcher will assess and observe the patients who are receiving the routine hospital nursing care during the four nights.
Intervention Type
Other
Intervention Name(s)
ear plug
Other Intervention Name(s)
eastnova ear plug
Intervention Description
The patients will receive the intervention (ear plug) in the third night (N3) from 9 pm to 6 am.
Intervention Type
Other
Intervention Name(s)
eye mask
Other Intervention Name(s)
Sleeping mask
Intervention Description
The patients will receive the intervention (eye mask) in the second night (N2) from 9 pm to 6 am.
Primary Outcome Measure Information:
Title
Sleep quality .
Description
to assess sleep quality by using quality of sleep questionnaire or the Richards-Campbell Sleep Questionnaire (RCSQ) (measured by Units on a Scale)
Time Frame
four days
Secondary Outcome Measure Information:
Title
Urine Melatonin
Description
as urine Melatonin ( pg/mL)
Time Frame
four days
Title
Cortisol level
Description
stress hormone as cortisol level (nmol/L)
Time Frame
four days
Title
Delirium assessment
Description
Assessment of delirium by using NEECHAM confusion scale or Nursing delirium screening scale (measured by Units on a Scale)
Time Frame
four days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sayed abd elshafy
Organizational Affiliation
associate professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Assiut
ZIP/Postal Code
74111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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