Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-01-02 @ 7:46 AM
Study NCT ID:
NCT06670859
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-17
First Post:
2024-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Mobilization Coverall on Anxiety, Comfort, Physical Privacy and Satisfaction
Sponsor:
Saglik Bilimleri Universitesi
Organization:
Study Overview
Official Title:
The Effect of Mobilization Coverall Designed for Intensive Care Patients on Anxiety, Comfort, Physical Privacy and Satisfaction:Crossover Randomized Controlled Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed as crossover randomized controlled trial to examine the effect of a mobilization coverall designed for intensive care patients on anxiety, comfort, physical privacy and satisfaction.
Detailed Description:
Patients receiving treatment in intensive care after surgical operation often experience a lack of privacy, comfort and control. One of the most important external factors affecting the experience of patients in the hospital is clothing. Hospital Gowns are made of clothes with special design and have a special place in the hospital experiences of patients during the perioperative period. Today, most hospital gowns consist of a single front panel, two back panels, sleeves and Two laces, and have a design with an opening in the back section. The design does not provide optimal functionality either for the patient wearing the hospital gown or for the medical personnel taking care of the patient. The current hospital gowns do not cover the body sufficiently, causing the patient to be embarrassed and dishonoring. Patients also express that the current apron lowers their self-esteem and makes them feel powerless and embarrassed. Failure to ensure the detection of drainage tubes causes patients to have difficulty during mobilization, causing drainage tubes to be held by medical personnel or the patient during mobilization. Additionally, in patient-focused qualitative studies in the literature, traditional hospital gowns worn by patients during mobilization cannot be tied or fully closed; It has been revealed that patients are more likely to want to stay in bed because of the concern that a part of their body will remain exposed or that their backrest will be exposed while walking. In this study, in order not to postpone mobilization, which has a positive effect on improving bowel functions, reducing the duration of intensive care and hospital stay, and increasing patient satisfaction, especially in the postoperative period; reducing anxiety regarding mobilization; A mobilization suit will be designed to protect the patient's physical privacy and increase his/her physical activity by ensuring his/her comfort during mobilization, and its effectiveness will be investigated.
The study will be conducted as a prospective crossover randomized controlled trial. After obtaining verbal and written consent from the participants before the study, the study will conduct with various data collection forms. These forms are; Individual Identification Form and Visual Analog Scale (VAS), Interview Form, Spielberger's State and Trait Anxiety Inventory (STAI), The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) will be used. Patients will randomize.
First Stage: Mobilization Coverall Design
The first stage of the study includes reviewing the studies in the literature on traditional hospital gowns used in the hospital and having the artistic and technical drawings of the mobilization suit designed by the researcher with the information obtained as a result of the observations of the researchers in line with their clinical experience drawn by the fashion design department in the city where the director works. Then, expert opinions will be obtained to determine the requirements and usage contexts of the mobilization suit design, produce design solutions, create a better design, improve the mobilization suit and determine the necessary changes through the visuals containing the front and back views of the artistic and technical drawings obtained.
Second Stage: Evaluating the Effectiveness of the Mobilization Coverall
The second stage of the study will conduct a crossover randomized controlled trial (RCT) to determine the effects of a mobilization coverall designed for intensive care patients on anxiety, comfort, physical privacy, and satisfaction.
Intervention-Control: includes the group of patients who will perform their first mobilization with a mobilization coverall and their second mobilization with a traditional hospital gown. Control-Intervention: includes the group of patients who will perform their first mobilization with a traditional hospital gown and their second mobilization with a mobilization gown.
The study will be conducted as a prospective crossover randomized controlled trial. After obtaining verbal and written consent from the participants before the study, the study will conduct with various data collection forms. These forms are; Individual Identification Form and Visual Analog Scale (VAS), Interview Form, Spielberger's State and Trait Anxiety Inventory (STAI), The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) will be used. Patients will randomize.
First Stage: Mobilization Coverall Design
The first stage of the study includes reviewing the studies in the literature on traditional hospital gowns used in the hospital and having the artistic and technical drawings of the mobilization suit designed by the researcher with the information obtained as a result of the observations of the researchers in line with their clinical experience drawn by the fashion design department in the city where the director works. Then, expert opinions will be obtained to determine the requirements and usage contexts of the mobilization suit design, produce design solutions, create a better design, improve the mobilization suit and determine the necessary changes through the visuals containing the front and back views of the artistic and technical drawings obtained.
Second Stage: Evaluating the Effectiveness of the Mobilization Coverall
The second stage of the study will conduct a crossover randomized controlled trial (RCT) to determine the effects of a mobilization coverall designed for intensive care patients on anxiety, comfort, physical privacy, and satisfaction.
Intervention-Control: includes the group of patients who will perform their first mobilization with a mobilization coverall and their second mobilization with a traditional hospital gown. Control-Intervention: includes the group of patients who will perform their first mobilization with a traditional hospital gown and their second mobilization with a mobilization gown.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: