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

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT03213860

Collaborator

(none)

Enrollment

Location

Arms

2.5

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Deprivation Postoperative Pain	Other: Flight Eye-masks; Dreaming, Zhuji City, Zhejiang, China	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 15, 2017

Actual Primary Completion Date :

Sep 29, 2017

Actual Study Completion Date :

Sep 29, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: eye mask	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.
No Intervention: Control

Arm

Intervention/Treatment

Active Comparator: eye mask

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.

No Intervention: Control

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut University hospital	Assiut	Asyut Governorate	Egypt	11111

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mostafa Samy Abbas, Lecturer, Assiut University

ClinicalTrials.gov Identifier:

NCT03213860

Other Study ID Numbers:

Pain & Sleep

First Posted:

Jul 11, 2017

Last Update Posted:

May 23, 2018

Last Verified:

May 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sleep Deprivation

Pain, Postoperative

Study Results

No Results Posted as of May 23, 2018