Abdominal Surgery PatientsNCT07607457
Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery
A study testing Enhanced patient gown in people with Abdominal Surgery Patients, run by Fenerbahce University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Surgery Patients
- What is being tested?
- Enhanced patient gown
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Abdominal Surgery Patients
- Being tested
- Enhanced patient gown
- Keywords
- Abdominal surgery, Patient gown, Functional design, Clinical care, Privacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced patient gownDevice
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 involved in the care and treatment of the enrolled patients (surgeons and surgical nurses) regarding the patient gown will be collected using the Patient Gown Evaluation Questionnaire for Healthcare Professionals.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients in the control group will be dressed in a traditional hospital gown. |
| Experimental Group | Experimental | Patients in this group will use the redesigned 100% cotton patient gown developed for abdominal surgery patients. Receives: Device: Enhanced patient gown |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ease of putting on and taking off the patient gown
Patients' ability to wear and remove the patient gown independently will be evaluated using a 10-point Visual Analog Scale (VAS), where 0 indicates "not satisfied at all" and 10 indicates "very satisfied."
Measured: Postoperative day 1 (24-48 hours after surgery)
Comfort During Mobilization With the Patient Gown
Patients' comfort while performing movements such as getting out of bed and walking while wearing the patient gown will be assessed using a 10-point Visual Analog Scale (VAS).
Measured: Postoperative day 1 (24-48 hours after surgery)
Perceived Privacy Protection Provided by the Patient Gown
Patients' perception regarding the adequacy of privacy protection provided by the patient gown will be evaluated using a 10-point Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates "not satisfied at all" and 10 indicates "very satisfied." Higher scores indicate better perceived privacy protection.
Measured: Postoperative day 1 (24-48 hours after surgery)
Ease of Access to Medical Devices and Dressing Areas
The extent to which the patient gown facilitates access to drains, catheters, and dressing areas during clinical care will be assessed using a 10-point Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates "not satisfied at all" and 10 indicates "very satisfied." Higher scores indicate better accessibility during clinical care.
Measured: Postoperative day 1 (24-48 hours after surgery)
Overall Comfort While Wearing the Patient Gown
Patients' overall comfort while wearing the patient gown will be evaluated using a 10-point Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates "not comfortable at all" and 10 indicates "extremely comfortable." Higher scores indicate greater patient comfort.
Measured: Postoperative day 1 (24-48 hours after surgery)
The sense of security felt when wearing a patient gown
Patients' sense of safety while using the patient gown will be assessed using a 10-point Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates "not safe at all" and 10 indicates "completely safe." Higher scores indicate a greater sense of safety while using the patient gown.
Measured: Postoperative day 1 (24-48 hours after surgery)
Perceived Workload During Patient Care While Using the Patient Gown
Healthcare professionals' perceptions regarding whether the patient gown increased workload during patient care procedures will be evaluated using a 10-point Visual Analog Scale (VAS), where 0 indicates "not satisfied at all" and 10 indicates "very satisfied."
Measured: Postoperative day 1 (24-48 hours after surgery)
Accessibility During Emergency Interventions While Using the Patient Gown
Healthcare professionals' perceptions regarding whether the patient gown interfered with emergency interventions and rapid access during urgent clinical situations will be evaluated using a 10-point Visual Analog Scale (VAS), where 0 indicates "not satisfied at all" and 10 indicates "very satisfied."
Measured: Postoperative day 1 (24-48 hours after surgery)
Suitability of the Patient Gown for Clinical Use
Healthcare professionals' perceptions regarding the suitability of the patient gown for routine clinical use in surgical patient care will be evaluated using a 10-point Visual Analog Scale (VAS), where 0 indicates "not satisfied at all" and 10 indicates "very satisfied."
Measured: Postoperative day 1 (24-48 hours after surgery)
Secondary outcomes (6)
Perceived Body Fit of the Patient Gown
Patients' perception regarding the compatibility of the patient gown with their body structure, including height, weight, and body shape, will be assessed using a 10-point Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates "not compatible at all" and 10 indicates "completely compatible." Higher scores indicate better compatibility of the patient gown with the patient's body structure.
Measured: Postoperative day 1 (24-48 hours after surgery)
The skin compatibility of the patient gown
Patients' perception regarding skin irritation associated with the patient gown will be evaluated using a 10-point Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates "severe skin irritation" and 10 indicates "no skin irritation." Higher scores indicate better skin compatibility and lower levels of skin irritation associated with the patient gown.
Measured: Postoperative day 1 (24-48 hours after surgery)
Comfort of the Gown Fastening System
Patients' comfort related to the fastening and tying structure of the patient gown will be assessed using a 10-point Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates "not comfortable at all" and 10 indicates "extremely comfortable." Higher scores indicate greater comfort related to the fastening and tying structure of the patient gown.
Measured: Postoperative day 1 (24-48 hours after surgery)
Thermal Comfort Provided by the Patient Gown
Patients' perception of thermal comfort, including the absence of excessive sweating or feeling cold while using the patient gown, will be evaluated using a 10-point Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates "not comfortable at all" and 10 indicates "extremely comfortable." Higher scores indicate greater thermal comfort while using the patient gown.
Measured: Postoperative day 1 (24-48 hours after surgery)
Satisfaction With the Appearance of the Patient Gown
Patients' satisfaction with the appearance of the patient gown, including its color, model, and design features, will be assessed using a 10-point Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates "not satisfied at all" and 10 indicates "very satisfied." Higher scores indicate greater satisfaction with the appearance of the patient gown.
Measured: Postoperative day 1 (24-48 hours after surgery)
Ease of Clinical Assessment While Using the Patient Gown
Healthcare professionals' perceptions regarding the ease of performing clinical assessments, such as vital sign monitoring and physical examination, while patients were wearing the patient gown will be evaluated using a 10-point Visual Analog Scale (VAS), where 0 indicates "not satisfied at all" and 10 indicates "very satisfied."
Measured: Postoperative day 1 (24-48 hours after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Abdominal Surgery PatientsStudies of the same condition, open and under way.
- More trials run by Fenerbahce UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Latest randomized controlled trial with a control group
- Masking
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Collaborators
- Bahçeşehir University
- Responsible party
- Principal investigator, Melis Merve Çetinkaya, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607457
- Sponsor's protocol ID
- 03.2026fbu
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37148935Zhao, 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.
PubMed 37393442Tazreean 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.
PubMed 35045757Syed S, Stilwell P, Chevrier J, Adair C, Markle G, Rockwood K. Comprehensive design considerations for a new hospital gown: a patient-oriented qualitative study. CMAJ Open. 2022 Dec 20;10(4):E1079-E1087. doi: 10.9778/cmajo.20210271. Print 2022 Oct-Dec.
PubMed 36735235Morton L, Cogan N, Kornfalt S, Porter Z, Georgiadis E. Baring all: The impact of the hospital gown on patient well-being. Br J Health Psychol. 2020 Sep;25(3):452-473. doi: 10.1111/bjhp.12416. Epub 2020 Apr 20.
PubMed 32314508Midha, V. K., Joshi, S., & Dakuri, A. (2022). Surgical gown fabrics in infection control and comfort measures at hospitals. Indian Journal of Fibre & Textile Research (IJFTR), 47(1), 96-104.
Lucas, C., & Dellasega, C. (2020). Finding common threads: How patients, physicians and nurses perceive the patient gown. Patient Experience Journal. https://doi.org/10.35680/2372-0247.1387
Kam S, Yoo Y. Patient Clothing as a Healing Environment: A Qualitative Interview Study. Int J Environ Res Public Health. 2021 May 18;18(10):5357. doi: 10.3390/ijerph18105357.
PubMed 34069861Joliat GR, Kobayashi K, Hasegawa K, Thomson JE, Padbury R, Scott M, Brustia R, Scatton O, Tran Cao HS, Vauthey JN, Dincler S, Clavien PA, Wigmore SJ, Demartines N, Melloul E. Guidelines for Perioperative Care for Liver Surgery: Enhanced Recovery After Surgery (ERAS) Society Recommendations 2022. World J Surg. 2023 Jan;47(1):11-34. doi: 10.1007/s00268-022-06732-5. Epub 2022 Oct 30.
PubMed 36310325Hwang, C., McCoy, L., & Shaw, M. (2020). Redesigning Maternity Hospital Gowns. Fashion Practice, 14, 79 - 98. https://doi.org/10.1080/17569370.2020.1794317
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery
- ClinicalTrials.gov ID
- NCT07607457
- Acronym / sponsor ID
- 03.2026fbu
- Conditions
- Abdominal Surgery Patients
- Keywords
- Abdominal surgery, Patient gown, Functional design, Clinical care, Privacy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Collaborators
- Bahçeşehir University
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Latest randomized controlled trial with a control group
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients in the control group will be dressed in a traditional hospital gown. |
| Experimental Group | Experimental | Device: Enhanced patient gownPatients in this group will use the redesigned 100% cotton patient gown developed for abdominal surgery patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced patient gownAs 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 involved in the care and treatment of the enrolled patients (surgeons and surgical nurses) regarding the patient gown will be collected using the Patient Gown Evaluation Questionnaire for Healthcare Professionals. | Device | Experimental Group |
Primary outcome
The ease of putting on and taking off the patient gown
Time frame: Postoperative day 1 (24-48 hours after surgery)
Patients' ability to wear and remove the patient gown independently will be evaluated using a 10-point Visual Analog Scale (VAS), where 0 indicates "not satisfied at all" and 10 indicates "very satisfied."
Comfort During Mobilization With the Patient Gown
Time frame: Postoperative day 1 (24-48 hours after surgery)
Patients' comfort while performing movements such as getting out of bed and walking while wearing the patient gown will be assessed using a 10-point Visual Analog Scale (VAS).
Perceived Privacy Protection Provided by the Patient Gown
Time frame: Postoperative day 1 (24-48 hours after surgery)
Patients' perception regarding the adequacy of privacy protection provided by the patient gown will be evaluated using a 10-point Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates "not satisfied at all" and 10 indicates "very satisfied." Higher scores indicate better perceived privacy protection.
Ease of Access to Medical Devices and Dressing Areas
Time frame: Postoperative day 1 (24-48 hours after surgery)
The extent to which the patient gown facilitates access to drains, catheters, and dressing areas during clinical care will be assessed using a 10-point Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates "not satisfied at all" and 10 indicates "very satisfied." Higher scores indicate better accessibility during clinical care.
Overall Comfort While Wearing the Patient Gown
Time frame: Postoperative day 1 (24-48 hours after surgery)
Patients' overall comfort while wearing the patient gown will be evaluated using a 10-point Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates "not comfortable at all" and 10 indicates "extremely comfortable." Higher scores indicate greater patient comfort.
The sense of security felt when wearing a patient gown
Time frame: Postoperative day 1 (24-48 hours after surgery)
Patients' sense of safety while using the patient gown will be assessed using a 10-point Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates "not safe at all" and 10 indicates "completely safe." Higher scores indicate a greater sense of safety while using the patient gown.
Perceived Workload During Patient Care While Using the Patient Gown
Time frame: Postoperative day 1 (24-48 hours after surgery)
Healthcare professionals' perceptions regarding whether the patient gown increased workload during patient care procedures will be evaluated using a 10-point Visual Analog Scale (VAS), where 0 indicates "not satisfied at all" and 10 indicates "very satisfied."
Accessibility During Emergency Interventions While Using the Patient Gown
Time frame: Postoperative day 1 (24-48 hours after surgery)
Healthcare professionals' perceptions regarding whether the patient gown interfered with emergency interventions and rapid access during urgent clinical situations will be evaluated using a 10-point Visual Analog Scale (VAS), where 0 indicates "not satisfied at all" and 10 indicates "very satisfied."
Suitability of the Patient Gown for Clinical Use
Time frame: Postoperative day 1 (24-48 hours after surgery)
Healthcare professionals' perceptions regarding the suitability of the patient gown for routine clinical use in surgical patient care will be evaluated using a 10-point Visual Analog Scale (VAS), where 0 indicates "not satisfied at all" and 10 indicates "very satisfied."
6 secondary outcomes
Perceived Body Fit of the Patient Gown
Time frame: Postoperative day 1 (24-48 hours after surgery)
The skin compatibility of the patient gown
Time frame: Postoperative day 1 (24-48 hours after surgery)
Comfort of the Gown Fastening System
Time frame: Postoperative day 1 (24-48 hours after surgery)
Thermal Comfort Provided by the Patient Gown
Time frame: Postoperative day 1 (24-48 hours after surgery)
Satisfaction With the Appearance of the Patient Gown
Time frame: Postoperative day 1 (24-48 hours after surgery)
Ease of Clinical Assessment While Using the Patient Gown
Time frame: Postoperative day 1 (24-48 hours after surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- BackgroundWang, 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
- Background: PubMed 37148935Xu 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.
- BackgroundZhao, 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
- BackgroundOyediran, 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
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced patient gown in people with Abdominal Surgery Patients, run by Fenerbahce University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melis M CETINKAYA (+905354159839, melis.cetinkaya@fbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ease of putting on and taking off the patient gown (time frame: Postoperative day 1 (24-48 hours after surgery)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07607457, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.