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

NCT07607457 | Not Yet Recruiting

• 1 other identifier: 03.2026fbu
• Study Type: interventional
• Target: 172
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Abdominal Surgery Patients

Keywords

Abdominal surgery; Patient gown; Functional design; Clinical care; Privacy

Outcome Measures

Primary Outcomes (9)

• 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."

  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).

  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.

  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.

  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.

  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.

  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."

  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."

  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."

  Postoperative day 1 (24-48 hours after surgery)

Secondary Outcomes (6)

• Perceived Body Fit of the Patient Gown

  Postoperative day 1 (24-48 hours after surgery)

• The skin compatibility of the patient gown

  Postoperative day 1 (24-48 hours after surgery)

• Comfort of the Gown Fastening System

  Postoperative day 1 (24-48 hours after surgery)

• Thermal Comfort Provided by the Patient Gown

  Postoperative day 1 (24-48 hours after surgery)

• Satisfaction With the Appearance of the Patient Gown

  Postoperative day 1 (24-48 hours after surgery)

Study Arms (2)

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.

Device: Enhanced patient gown

Interventions

Enhanced patient gown DEVICE

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fenerbahce University: lead
• Bahçeşehir University: collaborator

Related Publications (29)

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Central Study Contacts

Melis M CETINKAYA

CONTACT

+905354159839; melis.cetinkaya@fbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LECTURER

Model Details: Latest randomized controlled trial with a control group

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share