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

Not Applicable

Completed

• Conditions: Postoperative Pain; Sleep Deprivation
• Interventions: Other: Flight Eye-masks; Dreaming, Zhuji City, Zhejiang, China

• Registration Number: NCT03213860
• Lead Sponsor: Assiut University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-02
• Study First Submitted QC: 2017-07-10
• Study First Posted: 2017-07-11
• Study Start: 2017-07-15
• Primary Completion: 2017-09-29
• Study Completion: 2017-09-29
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-21
• Last Update Posted: 2018-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
eye mask	Flight Eye-masks; Dreaming, Zhuji City, Zhejiang, China	-

Primary Outcome Measures

Name	Time	Method
postoperative pain	3 postoperative days	visual analogue scale will be used. ranging from 0 mm (no pain) to 100 mm (worst pain imaginable).

Secondary Outcome Measures

Name	Time	Method
Quality of sleep	3 postoperative days	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.

Trial Locations

Locations (1)

Assiut University hospital; 🇪🇬 Assiut, Asyut Governorate, Egypt