Clinical trial NCT06670859: The Effect of Mobilization Coverall on Anxiety, Comfort, Physical Privacy and Satisfaction
Official title: The Effect of Mobilization Coverall Designed for Intensive Care Patients on Anxiety, Comfort, Physical Privacy and Satisfaction:Crossover Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Intensive Care Unit
Mobility
Patient
Keywords: Intensive Care Unit
Mobilization Coverall
Physical Privacy
Comfort
Anxiety
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Being literate in Turkish
* Having undergone a surgical operation
* Presence of a urinary catheter after surgery
* Presence of Jackson-Pratt and/or Hemovac Drain after surgery
* Agreeing to participate in the study

Exclusion Criteria:

* Patients who cannot be mobilized after surgery
* Not completing any phase of the study
* Wanting to withdraw from the study

Primary outcomes:
measure: Change in anxiety
timeFrame: It will be evaluated 5 minutes before clothing wear during
measure: Change in comfort
timeFrame: It will be evaluated 5 minutes after completing the 4 specified activities (putting on the clothes-mobilization-sitting in the wheel chair and moving-taking off the clothes)
measure: Change in protect their physical privacy
timeFrame: It will be evaluated 5 minutes after completing the 4 specified activities (putting on the clothes-mobilization-sitting in the wheel chair and moving-taking off the clothes)
measure: Change in satisfaction
timeFrame: It will be evaluated 5 minutes after completing the 4 specified activities (putting on the clothes-mobilization-sitting in the wheel chair and moving-taking off the clothes)
measure: satisfaction level for the designed mobilization coverall
timeFrame: It will be evaluated 30 minutes after the patients have experienced both clothing designs
Secondary outcomes:
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya City Hospital
Study officials:
affiliation: University of Health Sciences Turkiye Gulhane Faculty of Nursing Ankara, Turkey
name: Hatice Ayhan, PhD
role: STUDY_DIRECTOR
References:
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citation: Syed 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.
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