The Effect of Night Eye Mask on Post-operative Pain in Cardiac Surgery Patients

Postoperative Pain Clinical Trial

Official title:

The Effect of Night Eye Mask on Post-operative Pain in Cardiac Surgery Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03213860
• Other study ID #: Pain & Sleep
• Status: Completed
• Phase: N/A
• Start date: July 15, 2017
• Est. completion date: September 29, 2017

Study information

• Verified date: May 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Environmental factors such as noise and light have been cited as important causes of sleep deprivation in Intensive care unit (ICU) patients. Previous studies demonstrated a hyperalgesic alteration in pain perception following a controlled sleep deprivation protocol. Another studies indicated that using eye masks can improve REM sleep in healthy subjects in simulated ICU environment, and improve sleep quality in ICU patients. This study aimed to determine the effects of using eye masks on sleep and thus on pain quality in postoperative cardiac surgery patients in ICU.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 29, 2017
• Est. primary completion date: September 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• (1) age ?18 years; (2) no history of neurological or psychiatric disorders; (3) ability of patients to communicate verbally and understand the sleep questionnaires administered in the ICU; (3) length of ICU stay =48 hours; (4) Glasgow coma score (GCS) >8 in the first to third day. Postoperative Extubation of MV within few hour (before the time of 9 pm for postoperative patients.

Exclusion Criteria:

• Patients over age 65 were excluded from the study because of potential age-related differences in sleep. Patients reporting frequent nighttime awakenings, snoring, or chronic use of benzodiazepines or opioids were excluded because of potential confounding influences of these factors on postoperative sleep, pain, or opioid requirement.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Sleep Deprivation

Intervention

Other:
• Flight Eye-masks; Dreaming, Zhuji City, Zhejiang, China
The experimental group will receive protective devices Single use eye masks during nocturnal sleep (Flight Eye-masks; Dreaming, Zhuji City, Zhejiang, China). The caregiver will explain to them that they should wear eye masks during their stay in ICU to ensure rest and instructed patients to use them properly. During the ICU stay, ICU nurses will assist patients with wearing eye masks from 9:00 pm to 7:00 am the next morning.

Locations

Country	Name	City	State
Egypt	Assiut University hospital	Assiut	Asyut Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain	visual analogue scale will be used. ranging from 0 mm (no pain) to 100 mm (worst pain imaginable).	3 postoperative days
Secondary	Quality of sleep	the Arabic version of the Richards-Campbell Sleep Questionnaire (RCSQ)The five-point RCSQ was designed to evaluate different aspects of night-time sleep, including: (1) depth; (2) latency (time to fall asleep); (3) number of awakenings; (4) efficiency (percent of time awake), and (5) quality. Each item was scored using a 100-mm visual-analogue scale (VAS), which ranged from 0 mm (worst sleep) to 100 mm (optimal sleep). Total score was calculated by dividing the sum of all scores by five. The RCSQ was administered by the researcher daily, at 7:00am every morning.	3 postoperative days