Table 1.
Characteristics and outcomes of all studies included.
| First author, year, country | Study type | Setting | Sample size | Intervention | Assessment tools for sleep quality | Outcomes measure | Conclusion |
|---|---|---|---|---|---|---|---|
| Wallace, 1999, US (21) | Quasi-experimental randomized |
Healthy persons in simulated ICU environment | Total: 6 I: 3 C: 3 |
Earplugs | PSG | REM latency (mean): 106.7 (SD:53.0) vs. 147.8 (53.0); P = 0.02 REM phase (mean: 19.9 (SD: 4.5) vs. 14.9 (5.4); P = 0.04 |
Positive effect on improved of REM, REM latency and sleep efficiency index |
| Richardson, 2007, UK (13) | Quasi-experimental Non-randomized |
Cardiac ICU |
Total: 62 I: 34 C: 28 |
Eye masks and earplugs | Original questionnaires created by authors | ≥4 h sleep in intervention group: 15 (44.1%) ≥4 h sleep in control group: 10 (35.7%) |
Improved quantity sleep in intervention group, no improvement in sleep quality |
| Scotto, 2009, US (14) | Quasi-experimental Non-randomized |
Medical and cardiac ICU | Total: 88 I: 49 C: 39 |
Earplugs | VSHSS | Mean difference of sleep items score between two groups was (−3.253, P = 0.002) | Total sleep satisfaction scores were significantly better for the intervention group |
| Jones, 2008–2009, UK (22) | Pre-post study | General ICU | Total: 100 pre: 50 post: 50 |
Eye masks and earplugs | original questionnaires created by Richardson et al. (13) | ≥4 h sleep in pre-intervention group: 23 (46%) ≥4 h sleep in post-intervention group: 24 (48%) |
Patients reported sleeping for longer periods using earplugs and eye masks |
| Van Rompaey, 2008–2010, Belgium (23) | RCT | Medical and surgical ICU | Total:136 I: 69 C: 67 |
Earplugs | Original questionnaires created by authors | Sleeping with earplugs showed a significantly better sleep after the first night (P = 0.042) | Positive effects on sleep quality |
| Hu, 2009, China (24) | RCT | Cardiac Surgical ICU (CSICU) | Total: 45 I: 20 C:25 |
Eye masks and earplugs + relaxing music | RCSQ | Significant improved of subjective sleep quality and components in the intervention group | Positives effects of eye masks and earplugs on sleep quality |
| Hu, 2010, China (25) | Quasi-experimental randomized |
Healthy persons in simulated ICU environment | Total: 14 I: 7 C: 7 |
Eye masks and earplugs | PSG | Improved REM sleep, shorter REM latency, and fewer arousals, (P < 0.05) | Positives effects of eye masks and earplugs on sleep quality |
| Daneshmandi, 2010, Iran (26) | RCT | Coronary care unit (CCU) | Total: 60 I: 30 C: 30 |
Eye masks | PSQI | Mean score of overall PSQI after intervention in test and control group was (4.86 ± 1.88 and 8.43 ± 1.97; P < 0.05) | Significant improved of subjective sleep quality and components in the intervention group |
| Ryu, 2010, China (27) | Quasi-experimental randomized |
Coronary care unit (CCU) | Total: 58 I: 29 C:29 |
Eye masks and earplugs with relaxing music | VSHSS | Sleeping quantity: (279.3 ± 43.9 vs. 243.1 ± 42.6, P = 0.002 Sleep quality (36.1 ± 5.6 vs. 29.4 ± 3.8, P < 0.001) between groups |
Sleep-inducing music significantly improved sleep quality in patients |
| Nieseh, 2010, Iran (28) | RCT | Coronary care unit (CCU) | Total: 60 I: 30 C: 30 |
Eye masks and earplugs | PSQI | Significant differences in PSQI was observed after intervention between groups (experimental group 6 ± 2.3, control group 8.8 ± 2.4 (p < 0.05) | Using the ear and eye protect device significantly improved sleep quality |
| Neyse, 2011, Iran (29) | RCT | Coronary care unit (CCU) | Total: 60 I: 30 C: 30 |
Earplugs | PSQI | Significant differences in PSQI was observed after intervention between groups (experimental group 6.3 ± 2.1, control group 8.4 ± 1.9 (p < 0.05) | Using earplugs can improve sleep quality in patients |
| Baghaei, 2011–2012, Iran (30) | Quasi-experimental randomized |
Coronary care unit (CCU) | Total: 40 I: 20 C: 20 |
Eye masks | Leeds sleep evaluation questionnaire (LSEQ) | After intervention, the average total sleep score in control group was 4.8 ± 0.5, while in the eye mask group it was 6.7 ± 1.1 (P < 0.001) | Using of eye mask improves sleep quality in patients hospitalized in intensive cardiac care units |
| Mashayekhi, 2012, Iran (31) | Pre and post design | Coronary care unit (CCU) | Total: 60 I: 30 C: 30 |
Eye masks | VSHSS | In sub scale “effectiveness,” mean score of sleep quality was 255.33 ± 41.1 before intervention and 291.50 ± 38.9 after intervention | Using eye mask have statistically significant increased the quality of sleep in subscales disturbance and effectiveness |
| Yazdannik, 2012, Iran (32) | cross-over RCT | Surgery ICU | Total: 50 I: 25 C: 25 |
Eye masks and earplugs | VSHSS | Significant positive effects on sleep disturbance (P < 0.001) sleep supplementation (P < 0.01) sleep effectiveness (P = 0.03) |
Using of eye mask improves sleep quality in patients |
| Demoule, 2011–2013, France (33) | RCT | General ICU | Total: 51 I: 23 C: 28 |
Eye masks and earplugs | PSG | - Prolonged awakenings were less frequent in the intervention group (21 vs. 31, P = 0.02) | No significant difference was observed between two groups in terms of sleep quality |
| Guen, 2013, France, (34) | RCT | Post-anesthesia care units (PACUs) | Total: 41 I: 20 C: 21 |
Eye masks and earplugs | Medical Outcome Study Scale (MOSS) and the Spiegel Scale (SS) | In the intervention group, sleep disruptions evaluated with the MOSS scale were fewer [4 (1–7) vs. 7 (3–10), p < 0.05] | Using of eye mask improves sleep quality in patients |
| Babaii, 2013 Iran (35) | RCT | Coronary care unit (CCU) | Total: 60 I: 30 C: 30 |
Eye masks | PSQI | Median (IQR) score of overall PSQI after intervention in the experimental group were significantly lower than those in the control group [3 (5–2) vs. 10 (12–7), P < 0.05] | Using of eye mask improves sleep quality in patients |
| Kamdar, 2013, US (36) | Pre-post test study | Medical ICU | Total: 300 I: 110 C: 185 |
Earplugs | RCSQ | The use of earplugs and eye masks significant improved sleep quality P = 0.02 | Improvement quality of sleep |
| Bajwa, 2014, India (37) | RCT | General ICU | Total: 100 I: 50 C: 50 |
Eye masks and earplugs | VSHSS | sleep fragmentation (14.6 ± 3.44 vs. 4.19 ± 3.58), sleep latency (6.05 ± 1.88 vs. 1.70 ± 1.66), sleep quality (10.5 ± 2.52 vs. 2.14 ± 2.29), sleep length (8.95 ± 2.47 vs. 2.36 ± 2.46), sleep supplementation (11.8 ± 3.26 vs. 4.10 ± 2.33) in intervention and control groups, respectively |
Improvement quality of sleep |
| Huang, 2014, China (38) | RCT | Healthy persons in simulated ICU environment | Total: 40 I: 20 C: 20 |
Eye masks and earplugs | PSG | Less awakenings and shorter sleep onset latency in the intervention group (P < 0.05) | Improvement quality of sleep |
| Cheraghi, 2104, Iran (39) | RCT | Coronary care unit (CCU) | Total: 72 I: 36 C: 36 |
Earplugs | PSQI | The mean ± SD of quality of sleep for the intervention group using earplugs decreased from 8.11 ± 3.00 (before the intervention) to 6.00 ± 2.30 (after the intervention). It increased from 6.33 ± 3.08 to 8.80 ± 2.45 for the control group (P = 0.001) | Using of earplugs improves sleep quality in patients hospitalized in intensive cardiac care units |
| Litton, 2015–2016, Australia (40) | RCT | Surgery ICU | Total: 40 I: 20 C: 20 |
Earplugs | RCSQ | The median RCSQ sleep summary scores were 43 (IQR, 20–58) and 45 (IQR, 29–64) for the earplugs and no earplugs groups, respectively (median difference, 2; 95% CI,−21 to −25; P = 0.58) | No significant difference was observed between two groups in terms of sleep based on RCSQ |
| Chaudhary, 2016, India (41) | RCT | Medical ICU | Total: 60 I: 30 C: 30 |
Eye masks and earplugs | Original questionnaires created by authors | The sleep quality score was improved after the administration of earplugs and eye mask among both the groups (P < 0.001) | Improvement quality of sleep |
| Sharafi, 2016, Iran (42) | RCT | General and medical ICU | Total: 73 I: 36 C: 37 |
Eye masks and earplugs | VSHSS | Sleep quality score in intervention group and control group were 45.41 ± 3.78 and 45.45 ± 5.61, respectively. | No significant difference was observed between the groups |
| Sweity, 2017, UK (43) | RCT | Medical and surgical wards | Total: 206 I: 109 C: 97 |
Eye masks and earplugs | Original questionnaires created by authors | Sleep quality was significantly higher in intervention group, (5.09 ± 2.05 vs. 6.33 ± 2.13, mean difference was 1.24, P < 0.001) | Improvement quality of sleep |
| Bani Younis, 2017, Jordan, (44) | Quasi-experimental Randomized |
General ICU at 2 Hospital | Total: 103 I: 52 C: 51 |
Eye masks and earplugs | RCSQ | The mean RCSQ scores were (47.2 ± 16.5 vs. 36.2 ± 15.1, P < 0.001) for the intervention and control groups, respectively | Improvement quality of sleep |
| Dobing, 2017, Canada, (45) | Quasi-experimental Non-randomized |
General and medical | Total: 81 I: 40 C: 41 |
Eye masks and earplugs | VSHSS | Sleep disturbance (median 420 vs. 359, p = 0.19), efficacy (median 169 vs. 192, p = 0.29), and supplementation (median 97 vs. 100, p = 0.51) scales were not significant difference between groups | No significant difference was observed between the groups |
| Arttawejkul, 2017–2018, India (46) | RCT | Medical ICU | Total: 17 I: 8 C: 9 |
Eye masks and earplugs | PSG and RCSQ | Polysomnographic parameters including total sleep time, sleep efficiency, wake after sleep onset, sleep latency, % rapid eye movement (REM) sleep, and % N3 sleep were similar between two groups (P > 0.05) | Based on PSG sleep quality domains were similar between groups and subjective sleep quality according to RCSQ score did not demonstrate the difference between the groups |
| Koçak, 2017–2018, Turkey (47) | Quasi-experimental non-randomized |
Neurology ICU |
Total: 64 I: 32 C: 32 |
Eye masks and earplugs | RCSQ | The RCSQ mean (SD) pretest and posttest scores were 50.21 (16.02) and 68.50 (17.57), respectively, for the experimental group and 55.34 (16.62) and 49.03 (15.53), respectively, for the control group | Improvement quality of sleep |
| Obanor, 2018, US (48) | RCT | Surgical ICU | Total: 23 I: 12 C: 11 |
Eye mask s and earplugs | RCS) | Postoperative days 1 and 2 respectively, aggregate mean RCSQ scores were (29.42 ± 25 and 38.33 ± 25) in the control group (n = 9) vs. (54.77 ± 23) and (65.22 ± 24) in the intervention group (n = 14) | Improvement quality of sleep |
| Baghaie Lakeh, 2018, Iran (49) | Cross-over RCT | Coronary care unit (CCU) | Total: 96 I: 48 C: 48 |
Earplugs | VSHSS | In the first night; the use of earplugs significantly reduced the quality of sleep disturbance domain in both groups A and B (P = 0.0001 and P = 0.021, respectively), and the supplementary sleep domain in group A (P = 0.027). | No significant difference was observed between the groups |
| Ho, 2018–2019, US (50) | Non-Randomized Control Trial | General medical | Total: 215 I: 109 C: 106 |
Eye masks and earplugs | Insomnia severity index (ISI) questionnaire | No significant adjusted OR in terms of insomnia (OR: 0.8, 95% CI: 0.34–1.87, p = 0.61) Satisfaction score: (4.22 ± 1.08 vs. 4.36 ± 0.86, p > 0.05) duration of stay: (5.14 ± 6.75 vs. 5.47 ± 6.08, p > 0.05) |
No significant difference was observed between the groups |
| Obanor, 2018–2019, US (51) | RCT | Surgical ICU | Total: 87 I: 44 C: 43 |
Eye masks and earplugs | RCSQ | Compared with the control group's average RCSQ total score of 47.3 (95% CI, 40.8–53.8), the intervention group's average RCSQ total score was significantly higher at 64.5 (95% CI, 58.3–70.7; P = 0.0007) | Improvement quality of sleep |
| Mahran, 2107, Eygept (52) | RCT | Cardiac surgery intensive care unit (CSICU) | Total: 66 I: 31 C: 35 |
Eye masks | RCSQ | A statistically significant difference was found between groups in mean total RCSQ score over the 3-day study period (P = 0.001), with the intervention group reporting better sleep quality | Improvement quality of sleep |
| Leong, 2018–2019, Singapore (53) | RCT | General ICU | Total: 93 I: 48 C: 45 |
Eye masks and earplugs | RCSQ | Median [IQR (range)] sleep scores were 64 [38–74 (0–100)] and 60 [44–82 (18−100)] for the control and intervention groups, respectively (P = 0.310) | No significant difference was observed between the groups |
I, Intervention group; C, Control group; PSG, Polysomnography; RCSQ, Richards-Campbell Sleep Questionnaire; VSHSS, Verran-Snyder-Halpern Sleep Scale; PSQI, Petersburg's Sleep Quality Index.