Back to resultsThe Effect of Night Eye Mask on Post-operative Pain in Cardiac Surgery Patients
Primary Purpose
Sleep Deprivation, Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Flight Eye-masks; Dreaming, Zhuji City, Zhejiang, China
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Deprivation
Eligibility Criteria
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.
Sites / Locations
- Assiut University hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
eye mask
Control
Arm Description
Outcomes
Primary Outcome Measures
postoperative pain
visual analogue scale will be used. ranging from 0 mm (no pain) to 100 mm (worst pain imaginable).
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03213860
Brief Title
The Effect of Night Eye Mask on Post-operative Pain in Cardiac Surgery Patients
Official Title
The Effect of Night Eye Mask on Post-operative Pain in Cardiac Surgery Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 15, 2017 (Actual)
Primary Completion Date
September 29, 2017 (Actual)
Study Completion Date
September 29, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation, Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
While it is not possible to blind participants and clinical staff to the assigned interventions, the assessments will be undertaken by a researcher blinded to group allocation.
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
eye mask
Arm Type
Active Comparator
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Flight Eye-masks; Dreaming, Zhuji City, Zhejiang, China
Intervention Description
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.
Primary Outcome Measure Information:
Title
postoperative pain
Description
visual analogue scale will be used. ranging from 0 mm (no pain) to 100 mm (worst pain imaginable).
Time Frame
3 postoperative days
Secondary Outcome Measure Information:
Title
Quality of sleep
Description
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.
Time Frame
3 postoperative days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Assiut University hospital
City
Assiut
State/Province
Asyut Governorate
ZIP/Postal Code
11111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Night Eye Mask on Post-operative Pain in Cardiac Surgery Patients
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