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

Sleep Clinical Trial

— sayed  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02612636
• Other study ID #: IRB0000871100
• Status: Completed
• Phase: N/A
• First received: November 16, 2015
• Last updated: June 6, 2017
• Start date: November 2015
• Est. completion date: May 2017

Study information

• Verified date: June 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Sleep

Intervention

Other:
• ear plug
The patients will receive the intervention (ear plug) in the third night (N3) from 9 pm to 6 am.
• eye mask
The patients will receive the intervention (eye mask) in the second night (N2) from 9 pm to 6 am.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

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