Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery

Обзор

Traditional hospital gowns fail to protect patient privacy due to their design features, restrict freedom of movement and are incompatible with medical equipment. This situation negatively affects both patient satisfaction and the quality of care. The limited number of studies addressing this issue in the literature highlights the unique value of the topic. This project will be conducted with a randomized controlled design to develop a functional and ergonomic hospital gown suitable for clinical requirements for patients undergoing abdominal surgery and to evaluate its effectiveness. During the design process, priority will be given to privacy, ease of mobilization and integration with medical devices. The study first plans to produce a prototype of a cotton fabric apron. Technical modeling will be conducted in collaboration with the Department of Textile and Fashion Design at Bahçeşehir University; the prototype will then be evaluated for clinical suitability. In the second phase, an experimental study will be conducted at Medicana Hospital in Ataşehir, Istanbul, to assess the apron's effectiveness. The sample size was determined using power analysis to include 86 patients in each of the control and intervention groups, for a total of 172 patients, and 14 healthcare professionals will participate in the study. Patient and healthcare professional identification forms, along with patient apron evaluation questionnaires, will be used as data collection tools. The study consists of five main work packages: (1) obtaining the necessary permits and registering the research, (2) selecting materials and determining fabric properties, (3) technical modeling and design work, (4) patient trials, and (5) data analysis. Interdisciplinary collaboration will be maintained throughout the process, and the final model will be developed through iterative prototyping and pilot trials. The widespread impact of the project is expected to increase the quality of clinical care by enhancing the comfort and safety of surgical patients, facilitating the workflow of healthcare professionals and promoting sustainable textile usage. In addition, the commercialization of the developed product has the potential to make an economic contribution to the domestic textile sector.

Подробное описание

The use of a hospital gown begins with the patient's admission to the hospital and continues until discharge. The traditional hospital gowns used today were designed in the early 1900s. These gowns feature a design that ties at the back and has no opening at the front. Although there have been many innovations and changes in patient care over the years, patient gowns have remained one of the few elements that have remained unchanged in the treatment and care process. Since patient gowns are provided by the hospital, it is common for them not to be tailored to the patient and to fail to meet individual needs.

The negative effects of current hospital gowns are addressed in the literature from various perspectives. The first of these is a loss of control and emotional distress. It has been reported that wearing a hospital gown creates a distinct sense of loss of control in patients, increases stress levels, and reinforces feelings of exclusion.

Another significant area of concern is violations of privacy and dignity. Because the design of the traditional hospital gown does not adequately protect privacy, it leads to feelings of shame and a sense of being exposed and vulnerable among patients.

Physical discomfort and restricted mobility are also among the frequently criticized aspects of current gowns. The literature indicates that the lacing systems of gowns are difficult to use, do not fit the body properly, and restrict patients' movements. Additionally, the need for assistance when putting on or taking off a gown makes patients dependent on family members or healthcare professionals. It is noted that these functional limitations lead to more serious problems, particularly in elderly, obese, or mobility-impaired individuals.

All these factors lead to dissatisfaction among both patients and healthcare workers. Studies indicate that current patient gowns are not only impractical but also undermine patient identity and self-confidence, which negatively impacts the care process. For example, following surgical treatment, patients are advised to spend at least two hours out of bed on the day of surgery and six hours on subsequent days. However, the open back of the traditional patient gown prevents patients from safely leaving their room and walking around.

In light of these findings, the need for innovative and patient-centered design in healthcare has become inevitable. The literature emphasizes that alternative scrubs models to be developed must not only enhance patients' psychological and physical comfort but also meet healthcare professionals' needs for functionality and ease of use.

In this context, the development of new patient gown designs that protect privacy, fit the body well, and facilitate functional, patient-centered care is among the top priorities of modern healthcare. The aim of this study is to develop a new gown tailored to the needs of patients undergoing abdominal surgery and to evaluate the effectiveness of the developed patient gown. This study is unique due to the limited number of studies on this topic in the literature.

In this context, the following hypotheses have been constructed. H1: The developed patient gown increases the patient's physical comfort. H2: The developed patient gown increases the patient's independence. H3: The developed patient gown ensures the patient's privacy. H4: The developed patient gown facilitates easy access to medical equipment on the patient's body.

H5: The developed patient gown ensures the patient's safety. H6: The developed patient gown reduces the workload of healthcare professionals.

H7: The developed patient gown facilitates treatment and care processes for healthcare professionals.

Вмешательства

• Устройство Enhanced patient gown
  As part of the study, patients wearing the enhanced surgical gown will continue to wear the designated gown for at least 24 hours after achieving postoperative clinical stability (i.e., hemodynamically stable, awake, and able to move). The assessment will be conducted on the first postoperative day, within 24-48 hours after surgery. Following the completion of the enrollment period, data collection instruments will be administered to the patients. The opinions of healthcare professionals involve

Первичные конечные точки

• The ease of putting on and taking off the patient gown [Срок оценки: Postoperative day 1 (24-48 hours after surgery)]
• Comfort During Mobilization With the Patient Gown [Срок оценки: Postoperative day 1 (24-48 hours after surgery)]
• Perceived Privacy Protection Provided by the Patient Gown [Срок оценки: Postoperative day 1 (24-48 hours after surgery)]
• Ease of Access to Medical Devices and Dressing Areas [Срок оценки: Postoperative day 1 (24-48 hours after surgery)]
• Overall Comfort While Wearing the Patient Gown [Срок оценки: Postoperative day 1 (24-48 hours after surgery)]
• The sense of security felt when wearing a patient gown [Срок оценки: Postoperative day 1 (24-48 hours after surgery)]
• Perceived Workload During Patient Care While Using the Patient Gown [Срок оценки: Postoperative day 1 (24-48 hours after surgery)]
• Accessibility During Emergency Interventions While Using the Patient Gown [Срок оценки: Postoperative day 1 (24-48 hours after surgery)]
• Suitability of the Patient Gown for Clinical Use [Срок оценки: Postoperative day 1 (24-48 hours after surgery)]

Вторичные конечные точки (6)

• Perceived Body Fit of the Patient Gown [Срок оценки: Postoperative day 1 (24-48 hours after surgery)]
• The skin compatibility of the patient gown [Срок оценки: Postoperative day 1 (24-48 hours after surgery)]
• Comfort of the Gown Fastening System [Срок оценки: Postoperative day 1 (24-48 hours after surgery)]
• Thermal Comfort Provided by the Patient Gown [Срок оценки: Postoperative day 1 (24-48 hours after surgery)]
• Satisfaction With the Appearance of the Patient Gown [Срок оценки: Postoperative day 1 (24-48 hours after surgery)]
• Ease of Clinical Assessment While Using the Patient Gown [Срок оценки: Postoperative day 1 (24-48 hours after surgery)]

Критерии участия

Patient Inclusion Criteria for the Study:

• Be 18 years of age or older
• Have undergone major abdominal surgery performed on an elective basis in a general surgery clinic (e.g., colorectal surgery, gastric surgery, hepatobiliary surgery, etc.)
• Currently receiving care and treatment with medical devices (e.g., drains, Foley catheters, etc.)
• Willing to participate in the study

Patient Inclusion Criteria for the Study:

• The participant refuses to wear a hospital gown
• The participant has an allergy to the specified fabric Patients who are unable to mobilize for any reason (paralysis, general health impairment, history of stroke, etc.)
• Patients with difficulty speaking and understanding Turkish
• Patients lacking cognitive competence
• Patients who develop complications within the first 24 hours after surgery and require revision surgery
• Patients with prolonged intensive care unit (ICU) stays during the postoperative period
• Since both the standard-sized traditional patient gown and the newly developed patient gown (available in sizes M-L) will be used in the study, patients whose body measurements do not fit within this size range will not be included in the study. This approach was adopted to prevent differences in comfort, mobility, and safety resulting from size mismatch from influencing the results, to ensure standardization in measurements, and to maintain comparability between the intervention and control groups.

Inclusion Criteria for Healthcare Professionals in the Study:

• Providing care to patients who have undergone abdominal surgery
• Having worked in the field for more than one year
• Volunteering to participate in the study

Exclusion Criteria for Healthcare Professionals in the Study:

• Being on leave or on sick leave during the study period.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Wang, L., Luu, S., Li, R., Song, G. 2022. "Thermal Comfort Evaluation of Medical Gowns Using Sweating Thermal Manikin", International Textile and Apparel Association Annual Conference Proceedings, 78(1). https://doi.org/10.31274/itaa.13497
• Xu Q, Wang X, Zhang Y. Green and sustainable fabrication of a durable superhydrophobic cotton fabric with self-cleaning properties. Int J Biol Macromol. 2023 Jul 1;242(Pt 1):124731. doi: 10.1016/j.ijbiomac.2023.124731. Epub 2023 May 5. PMID 37148935
• Zhao, Y., Zhou, F., Zhao, Y., Zou, Y., Wei, X. 2024. "Development of an Emotional Response Model for Hospital Gown Design Using Structural Equation Modeling", AUTEX Research Journal, 24(1), 20230010. https://doi.org/10.1515/aut-2023-0010
• Oyediran, O. O., Animasahun, T. R., Fawole, I. O., Solanke, B. L., Suleiman, A. A. 2024. "Prevalence and Clinical Outcomes of Abdominal Surgeries in a South Western Nigerian University Teaching Hospital Between March 2017-October 2021", Tropical Journal of Health Sciences, 31(4), 31-37. https://doi.org/10.4314/tjhc.v31i4.5
• Hwang, C., McCoy, L., Shaw, M. 2020. "Redesigning Maternity Hospital Gowns", Fashion Practice, 14, 79-98. https://doi.org/10.1080/17569370.2020.1794317
• Gün, A. D., Bodur, A. 2014. "Kumaşların Su Buharı Geçirgenliği", Electronic Journal of Vehicle Technologies / Taşıt Teknolojileri Elektronik Dergisi, 8(3).
• Chen H, Dong P, Zhong P. The effect of a new design of patient gowns for prone position patients after vitrectomy: A non-randomized, concurrent, controlled study. Technol Health Care. 2024;32(1):55-62. doi: 10.3233/THC-220455. PMID 37393442
• Tazreean R, Nelson G, Twomey R. Early mobilization in enhanced recovery after surgery pathways: current evidence and recent advancements. J Comp Eff Res. 2022 Feb;11(2):121-129. doi: 10.2217/cer-2021-0258. Epub 2022 Jan 20. PMID 35045757

Идентификаторы

NCT: NCT07607457 · 03.2026fbu

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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