Development and validation of an environmental protocol to enhance sleep and pain outcomes in intensive care unit patients
https://doi.org/10.47093/2218-7332.2025.16.4.31-40
摘要
Aim. To develop a multimodal environmental modification protocol for the intensive care unit (ICU) and evaluate its feasibility and preliminary associations with sleep quality and pain intensity in patients.
Materials and methods. A quasi-experimental, single-arm study involving 152 adult patients was conducted from June to August 2025 in the ICU of a Type B hospital in Central Java, Indonesia. Environmental modifications included six interventions: earplugs, eye masks, music therapy, lavender aromatherapy, lighting adjustments, and noise reduction measures, which were applied daily for three consecutive nights (content validity = 0.94). Sleep quality was measured using the Richards-Campbell Sleep Questionnaire (RCSQ), and pain intensity was measured using the numeric rating scale (NRS). Paired t-tests, 95% confidence intervals (CI), and Cohen's d were used to describe intervention effectiveness. Normality of distribution was tested using the Shapiro–Wilk test.
Results. All 152 ICU participants completed the three-day protocol, with overall adherence being 94%. Mean RCSQ scores improved from 34.6 with 11.3 to 51.8 with 10.6 (95% CI: 15.46–18.94; paired t-test, p < 0.001; Cohen's d = 1.57). Mean NRS scores decreased from 4.7 with 1.8 to 2.8 with 1.3 (95% CI: −2.15 to −1.65; paired t-test, p < 0.001; Cohen's d = 1.21). No adverse events were noted. Objective environmental monitoring (subsample n = 40) showed a mean reduction in noise and lighting levels at the patient's bedside during the intervention.
Conclusion. The protocol for creating a positive environment in the ICU was feasible, acceptable, and resulted in subjective improvements in sleep quality and pain intensity in patients.
关于作者
B. Waladani
Universitas Muhammadiyah Gombong (UNIMUGO)
印度尼西亚
印度尼西亚
E. Setianingsih
Universitas Muhammadiyah Gombong (UNIMUGO)
印度尼西亚
印度尼西亚
M. Hidayah
Universitas Muhammadiyah Gombong (UNIMUGO)
印度尼西亚
印度尼西亚
参考
1. Bolin M.C., Sweetman M.M. Sleep in the intensive care unit (ICU): an overlooked opportunity for occupational therapists to fill a gap in health care service. Open J Occup Ther. 2022; 10(1): 1–5. https://doi.org/10.15453/2168-6408.1846
2. Hillman D.R. Sleep loss in the hospitalized patient and its influence on recovery from illness and operation. Anesth Analg. 2021 May; 132(5): 1314–1320. https://doi.org/10.1213/ANE.0000000000005323. PMID: 33857973
3. Ashghab A., Vahedian-Azimi A., Vafadar Z., et al. Nursing interventions to improve the sleep quality of hospitalized patients: a systematic review and meta-analysis. Intensive Care Res. 2024; 4: 55–71. https://doi.org/10.1007/s44231-024-00056-9
4. Alegria L., Brockmann P., Repetto P., et al. Improve sleep in critically ill patients: study protocol for a randomized controlled trial for a multi-component intervention of environment control in the ICU. PLoS One. 2023 May; 18(5): e0286180. https://doi.org/10.1371/journal.pone.0286180. PMID: 37228142
5. Honarmand K., Bosma K.J. Risk factors for disrupted sleep in the ICU. In: Weinhouse G.L., Devlin J.W., editors. Sleep in Critical Illness. Cham: Springer; 2022. P. 91–108. https://doi.org/10.1007/978-3-031-06447-0_6
6. Vaishnav P.P., Suresh A., Kooragayalu S., Kooragayalu S. Sleep disturbances in hospitalized and intensive care unit patients. In: BaHammam A.S., Hunasikatti M., editors. Sleep Apnea Frontiers. Progress in Sleep Research. Singapore: Springer; 2023. P. 231– 253. https://doi.org/10.1007/978-981-99-7901-1_15
7. Li H.C., Yeh T.Y., Wei Y.C., et al. Association of incident delirium with short-term mortality in adults with critical illness receiving mechanical ventilation. JAMA Netw Open. 2022 Oct; 5(10): e2235339. https://doi.org/10.1001/jamanetworkopen.2022.35339. PMID: 36205994
8. Stollings J.L., Kotfis K., Chanques G., et al. Delirium in critical illness: clinical manifestations, outcomes, and management. Intensive Care Med. 2021 Oct; 47(10): 1089–1103. https://doi.org/10.1007/s00134-021-06503-1. Epub 2021 Aug 16. PMID: 34401939
9. Mart M.F., Williams Roberson S., Salas B., et al. Prevention and management of delirium in the intensive care unit. Semin Respir Crit Care Med. 2021 Feb; 42(1): 112–126. https://doi.org/10.1055/s-0040-1710572. Epub 2020 Aug 3. PMID: 32746469
10. Wu N., Zhang B., Wang Y., et al. Incidence, prevalence and risk factors of delirium in ICU patients: A systematic review and meta-analysis. Nurs Crit Care. 2023; 28: 653–669. https://doi.org/10.1111/nicc.12857
11. Waladani B., Utami W., Ernawati, Suwaryo P.A.W. Improving sleep quality among ICCU patients – evaluating the effectiveness of ear plug and eye mask interventions. Eur J Clin Exp Med. 2024; 22(4): 748–755. https://doi.org/10.15584/ejcem.2024.4.9
12. Bahcecioglu Turan G., Gürcan F., Özer Z. The effects of eye masks and earplugs on sleep quality, anxiety, fear, and vital signs in patients in an intensive care unit: a randomised controlled study. J Sleep Res. 2024 Apr; 33(2): e14044. https://doi.org/10.1111/jsr.14044. Epub 2023 Sep 18. PMID: 37723617
13. Holm A., Nikolajsen L., Dreyer P. A multicomponent intervention to optimise nurse–patient communication in the intensive care unit: a mixed-methods acceptability and feasibility study. Aust Crit Care. 2022 Nov; 35(6): 616–622. https://doi.org/10.1016/j.aucc.2021.09.008. Epub 2021 Nov 18. PMID: 34802842
14. Ijaz N., Nader M., Ponticiello M., et al. Contextual factors influencing bubble continuous positive airway pressure implementation for paediatric respiratory distress in low-income and middle-income countries: a realist review. Lancet Glob Health. 2025 Feb; 13(2): e232–e245. https://doi.org/10.1016/S2214-109X(24)00453-4. Epub 2024 Dec 12. PMID: 39675373
15. Rendon A., Luhning S., Bardin P., et al. Recommendations for improving discharge-related care following a COPD exacerbation: an expert panel consensus with emphasis on low- and middleincome countries. Int J Chron Obstruct Pulmon Dis. 2025 Apr; 20: 1111–1129. https://doi.org/10.2147/COPD.S502971. PMID: 40260081
16. Bartlett E.S., Lim A., Kivlehan S., et al. Critical care delivery across health care systems in low-income and low-middle-income country settings: a systematic review. J Glob Health. 2023 Dec; 13: 04141. https://doi.org/10.7189/jogh.13.04141. PMID: 38033248
17. Macey A., O'Reilly G., Williams G., Cameron P. Critical care nursing role in low and lower middle-income settings: a scoping review. BMJ Open 2022 Jan; 12(1): e055585. https://doi.org/10.1136/bmjopen-2021-055585. PMID: 34983772
18. Cardoso S.B., Oliveira I.C.S., Souza T.V., Carmo S.A. Pediatric intensive care unit: reflection in the light of Florence Nightingale’s environmental theory. Rev Bras Enferm. 2021; 74(5): e20201267. https://doi.org/10.1590/0034-7167-2020-1267. PMID: 34320154
19. Riegel F., Crossetti M.G.O., Martini J.G., Nes A.A.G. Florence Nightingale's theory and her contributions to holistic critical thinking in nursing. Rev Bras Enferm. 2021; 74(2): e20200139. https://doi.org/10.1590/0034-7167-2020-0139. PMID: 33950115
20. Shkodina A.D., Boiko D.I. A conception of integrated phased model combining sleep hygiene and stimulus control as an adult sleep education approach. Front Neurol. 2024 Dec; 15: 1513509. https://doi.org/10.3389/fneur.2024.1513509. PMID: 39744111
21. Edinger J.D., Arnedt J.T., Bertisch S.M., et al. Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021 Feb; 17(2): 255–262. https://doi.org/10.5664/jcsm.8986. PMID: 33164742
22. Blampied N.M., van Deurs J. A conceptual framework for understanding and designing behavioral interventions for sleep problems in children on the autism spectrum. In: McLay L.K., France K.G., Blampied, N.M., editors. Clinical Handbook of Behavioral Sleep Treatment in Children on the Autism Spectrum. Cham: Springer; 2022. P. 59–74. https://doi.org/10.1007/978-3-030-99134-0_5
23. Kakar E., Ottens T., Stads S., et al. Effect of a music intervention on anxiety in adult critically ill patients: a multicenter randomized clinical trial. J Intensive Care. 2023 Aug; 11(1): 36. https://doi.org/10.1186/s40560-023-00684-1. PMID: 37592358
24. Richards K.C., O’Sullivan P.S., Phillips R.L. Measurement of sleep in critically ill patients. J Nurs Meas. 2000 Fall-Winter; 8(2): 131–144. PMID: 11227580
25. Breivik H., Borchgrevink P.C., Allen S.M., et al. Assessment of pain. Br J Anaesth. 2008 Jul; 101(1): 17–24. https://doi.org/10.1093/bja/aen103. Epub 2008 May 16. PMID: 18487245
26. Wu T., Qi H., Hui K., et al. Effect of noise isolation with noisecancelling earmuffs during laparoscopic surgery on acute postoperative pain: a clinical randomised controlled trial. BMC Anesthesiol. 2025 Oct; 25(1): 498. https://doi.org/10.1186/s12871-025-03369-4. PMID: 41087929
27. Hu L., Wang E.J. Sleep as a therapeutic target for pain management. Curr Pain Headache Rep. 2023 Jun; 27(6): 131–141. https://doi.org/10.1007/s11916-023-01115-4. Epub 2023 May 10. PMID: 37162641
28. Rampes S., Ma K., Divecha Y.A., et al. Postoperative sleep disorders and their potential impacts on surgical outcomes. J Biomed Res. 2019 Aug; 34(4): 271–280. https://doi.org/10.7555/JBR.33.20190054. PMID: 32519977
29. Bienefeld N., Keller E., Grote G. AI interventions to alleviate healthcare shortages and enhance work conditions in critical care: qualitative analysis. J Med Internet Res. 2025 Jan; 27: e50852. https://doi.org/10.2196/50852. PMID: 39805110
30. McNelly A., Langan A., Bear D.E., et al. A pilot study of alternative substrates in the critically Ill subject using a ketogenic feed. Nat Commun. 2023 Dec; 14(1): 8345. https://doi.org/10.1038/s41467-023-42659-8. PMID: 38102152
31. Zhang X.L., Zhang X., Hua W., et al. Expert consensus on the diagnosis, treatment, and prevention of respiratory syncytial virus infections in children. World J Pediatr. 2024 Jan; 20(1): 11–25. https://doi.org/10.1007/s12519-023-00777-9. Epub 2023 Dec 8. Erratum in: World J Pediatr. 2024 Feb 25. https://doi.org/10.1007/s12519-023-00792-w. PMID: 38064012
32. Whale K., Dennis J., Wylde V., et al. The effectiveness of nonpharmacological sleep interventions for people with chronic pain: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2022 May; 23(1): 440. https://doi.org/10.1186/s12891-022-05318-5. PMID: 35546397
33. Chlan L.L., Weinert C.R., Heiderscheit A., et al. Effects of Patient-Directed Music Intervention on Anxiety and Sedative Exposure in Critically Ill Patients Receiving Mechanical Ventilatory Support: A Randomized Clinical Trial. JAMA. 2013 Jun; 309(22): 2335– 2344. https://doi.org/10.1001/jama.2013.5670. PMID: 23689789
34. Devlin J.W., Skrobik Y., Gélinas C., et al. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/ Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep; 46(9): e825–e873. https://doi.org/10.1097/CCM.0000000000003299. PMID: 30113379
评论
Sechenov Medical Journal. Editor's checklist for this article you can find here.
Журнал «Сеченовский вестник» |
| Sechenov Medical Journal |
Рецензии на рукопись |
| Peer-review reports |
Название / Title | Разработка и валидация протокола модификации окружающей среды, влияющей на качество сна и интенсивность боли у пациентов отделения интенсивной терапии / Development and validation of an environmental protocol to enhance sleep and pain outcomes in intensive care unit patients
|
Раздел / Section
| ХИРУРГИЯ/ SURGERY
|
Тип / Article | Оригинальная статья / Original article |
Номер / Number | 1354
|
Страна/территория / Country/Territory of origin | Индонезия / Indonesia |
Язык / Language | Английский / English
|
Источник / Manuscript source | Инициативная рукопись / Unsolicited manuscript |
Дата поступления / Received | 03.10.2025
|
Тип рецензирования / Type ofpeer-review | Двойное слепое / Double blind |
Язык рецензирования / Peer-review language | Английский / English
|
РЕЦЕНЗЕНТ А / REVIEWER A
Инициалы / Initials | 1354_А
|
Научная степень / Scientific degree | Кандидат медицинских наук / PhD
|
Страна/территория / Country/Territory | Малайзия / Malaysia
|
Дата рецензирования / Date of peer-review | 05.12.2025 |
Число раундов рецензирования / Number of peer-review rounds | 2 |
Финальное решение / Final decision | Принять к публикации / accept
|
ПЕРВЫЙ РАУНД РЕЦЕНЗИРОВАНИЯ / FIRST ROUND OF PEER-REVIEW
Scientific quality: Grade C: Good
Language quality: Grade B: Minor language polishing
Overall assessment: The study addresses an important issue which is improving sleep and pain outcomes in ICU patients through environmental modification. However, several methodological, statistical, and reporting weaknesses limit the validity of the findings. Major revision is required before the paper can be considered for publication.
Major Comments
Study Design:
- A single-group pre–post design cannot establish causality. Conclusions should be toned down to emphasize feasibility and association only.
Sampling & Participants:
- Sampling method is inconsistently described (purposive vs. consecutive).
- Inclusion/exclusion criteria and definition of “hemodynamic stability” need clarification.
Safety & Ethics:
- Noise reduction and alarm minimization may raise patient-safety concerns. The manuscript must explain how critical alarms were handled and confirm ethical approval for this.
- Describe screening for lavender or essential oil allergies and monitoring for adverse events.
Statistical Issues:
- Cohen’s d appears miscalculated (should be ~1.6, not 1.95). Report exact test statistics and 95% confidence intervals.
- Provide details on normality testing and missing data handling.
Adherence & Feasibility:
- Explain the difference between “100% completion” and “94% adherence.” Include a table showing adherence for each component.
Data Transparency:
- Add 95% confidence intervals and relevant statistical tests for categorical data (e.g., McNemar).
- Clarify whether objective environmental data (noise/light levels) were recorded.
Minor Comments
- Ensure consistent terminology and correct minor typos.
- Provide brand information disclaimer (no sponsorship).
- Include ethics approval number and clarify trial registration status.
- Revise overstatements in the abstract and conclusion.
The study is feasible and relevant but must clarify methodology, correct statistical reporting, and ensure patient safety and transparency before publication.
CONCLUSION: major revision.
THE SECOND ROUND OF PEER REVIEW
All reviewer's comments have been addressed by the authors.
Recommended for publication.
РЕЦЕНЗЕНТ B / REVIEWER B
Инициалы / Initials | 1354_В
|
Научная степень / Scientific degree | Кандидат медицинских наук / PhD
|
Страна/территория / Country/Territory | Индонезия / Indonesia
|
Дата рецензирования / Date of peer-review | 03.12.2025 |
Число раундов рецензирования / Number of peer-review rounds | 2 |
Финальное решение / Final decision | Переработка и повторное рецензирование / major revision |
ПЕРВЫЙ РАУНД РЕЦЕНЗИРОВАНИЯ / FIRST ROUND OF PEER-REVIEW
Scientific quality: Grade C: Good
Language quality: Grade B: Minor language polishing
This study explores an important and under-researched area in critical care nursing — the use of multimodal environmental modification to enhance patient comfort, sleep, and pain control. The manuscript is well organized, clear, and supported by relevant literature. However, several substantive revisions are needed to strengthen scientific rigor and alignment with the study design.
Major points for revision:
- Reframe the study as a feasibility or preliminary evaluation rather than an effectiveness trial, consistent with its pre-experimental single-group design.
- Clarify methodological details, particularly regarding adherence measurement, safety assessment, and flow of participants.
- Relocate procedural descriptions (screening, safety monitoring) from the Results to the Methods section.
- Study Design and Interpretation
- The current pre-experimental single-group design limits causal inference. Please reframe the study as a feasibility or preliminary evaluation, rather than an effectiveness trial.
- Avoid causal or confirmatory terms such as “clinically beneficial,” “effectiveness,” or “reinforces current evidence.” Replace with neutral phrasing such as “showed improvements” or “indicated potential benefit.”
- Clarify how the study design minimized bias (e.g., standardization of measurement, blinding of assessors if any, or data collection procedures).
- Methods Section
- Relocate or clearly separate procedural descriptions (e.g., participant screening, safety monitoring) from the Results section to maintain structural consistency.
- Provide greater detail on adherence measurement — how was the 94% adherence calculated, and what criteria defined completion?
- Expand on how safety and feasibility were assessed (tools, definitions, or criteria).
- Clarify whether the same staff administered and evaluated the intervention, as this could introduce observer bias.
- Results Section
- Simplify the flow description and ensure Figure 1 follows TREND or CONSORT-like standards (screened → excluded → enrolled → analyzed).
- Remove redundant mentions of “no adverse events” and “tolerated well”; report these once, concisely.
- Avoid overinterpretation of statistical outcomes; present them descriptively given the lack of a control group.
- Discussion Section
- Strengthen critical reflection on study limitations, especially regarding internal validity and potential expectancy bias.
- Tone down overstatements about effectiveness and generalizability. Replace confirmatory statements with cautious interpretation aligned with preliminary design.
- Link discussion points more directly to existing meta-analyses or RCTs to show how your results align or differ.
- Provide more explicit justification of the study’s novelty — clarify what aspect of the environmental modification protocol truly differentiates it from previous multimodal interventions.
- Conclusion Section
- Revise to reflect the study’s true evidence level. Emphasize content validity, feasibility, and preliminary findings, rather than confirmed effectiveness.
- Rephrase claims of safety and scalability as “potentially safe” or “promising for broader application pending further validation.”
- Limitations and Future Research
- Avoid redundancy between the two sections: merge overlapping sentences on RCT recommendations.
- Deepen the analysis by explaining how specific limitations might have influenced results (e.g., expectancy bias, short follow-up).
- Add a note on contextual applicability — how ICU settings in resource-limited environments might affect feasibility and scalability.
- Language and Structure
- The manuscript is overall well written; only minor polishing is needed to improve fluency and reduce repetition.
- Ensure consistent academic tone and cautious wording throughout the Abstract, Discussion, and Conclusion.
In addition to this review text, please view the reviewer's comments in the attached file with the text of your manuscript.
CONCLUSION: major revision.
THE SECOND ROUND OF PEER REVIEW
Unfortunately, the reviewer did not respond to the editorial repeated requests.
РЕКОМЕНДАЦИИ НАУЧНЫХ РЕДАКТОРОВ ЖУРНАЛА / RECOMMENDATIONS
OF THE SCIENTIFIC EDITORS OF THE JOURNAL
Title
Spell out the ICU abbreviation in the title as “intensive care unit” instead of using only “ICU”.
Introduction
Shorten the Introduction, remove repetitive wording and self‑evident statements, and strengthen the focus on: the burden of sleep disturbances and pain in intensive care units, the lack of multicomponent protocols, especially in low‑ and middle‑income countries (LMICs).
Clearly formulate the aim of the study at the end of the Introduction.
Materials and methods
Standardize the description of the study design; rewrite the “Sampling”/“Recruitment” section to avoid wording suggestive of convenience sampling and to emphasize consecutive recruitment of all eligible patients during the study period.
Clearly separate inclusion criteria, exclusion criteria, and the screening algorithm.
Clarify the intervention protocol by:
- using consistent descriptions of all components (eye mask, earplugs, music, lavender, light <50 lux, quiet hours);
- explicitly stating the timing (21:00–06:00, 3 consecutive nights, 30 minutes of music before sleep);
- describing fidelity control (checklists, monitoring by nurses).
Standardize the description of materials (brand/model of eye masks, earplugs, diffuser, music tracks) in line with journal style, avoiding unnecessary commercial details.
Describe content validation of the protocol more clearly (approach, indices, thresholds).
Distinguish primary and secondary outcomes explicitly.
Expand the statistical analysis section to:
- describe assessment of normality (Shapiro–Wilk test);
- provide the formula for Cohen’s d with pooled SD;
- indicate the use of McNemar’s test for categorical shifts;
- specify the significance level α = 0.05 and the absence of missing data.
Explain the rationale for the sample size in the context of a feasibility study.
Results
Restructure the Results section into logical subsections (e.g. baseline characteristics, feasibility outcomes, clinical outcomes, categorical changes), ensuring a clear sequence and alignment with tables and figures.
Discussion, limitations, future directions
Reduce the strength of claims about “synergistic effects” and “strong impact”, replacing them with more cautious wording such as “potential benefit” and “large pre‑post changes within a feasibility context”.
Separate the “Limitations” and “Directions for further research” sections, with a clear list of methodological limitations (single‑center, single‑arm design, short follow‑up, subjective outcomes, lack of blinding).
Tables, figures, language
Bring all tables and figures into a unified journal style:
- clear, informative captions;
- explanation of all abbreviations in footnotes;
- correct and consistent citations of tables and figures in the text;
Carefully revise the text for syntax and terminology (ICU, feasibility, adherence, environmental modification), avoiding repetition and overly complex sentences.
浏览:
684
JATS XML
Email this article 