The Effect of Mobilization Coverall on Anxiety, Comfort, Physical Privacy and Satisfaction

NCT06670859 | Enrolling By Invitation

• 1 other identifier: Dr-2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care Unit; Mobility; Patient

Keywords

Intensive Care Unit; Mobilization Coverall; Physical Privacy; Comfort; Anxiety

Outcome Measures

Primary Outcomes (5)

• Change in anxiety

  Patients' anxiety levels will be measured with the State and Trait Anxiety Scale. Scale 1-20. account, state anxiety scaleen STAI-1 and subsequent 21-40. The questions consist of a total of 40 questions and two parts, including STAI-2, which measures trait anxiety. The constant production of anxiety requires how the individual usually expresses it. The emotions and behaviors expressed in trait anxiety behavior are, according to their frequency. The highest score that can be obtained from the scale is 80 and the lowest score is 20. A high score indicates high anxiety, and a low score indicates low anxiety. Additionally, anxiety level can be graded according to the score range: 0-19 points: No anxiety, 20-39 points: Mild anxiety, 40-59 points: Moderate anxiety, 60-79 points: Severe anxiety, 80 points: Severe anxiety (panic). It is evaluated as.

  It will be evaluated 5 minutes before clothing wear during

• Change in comfort

  The level of comfort they felt with the clothes they wore during mobilization.In this section, the degree of comfort level will increase or decrease. This situation will be evaluated with the Visual Analog Scale (VAS). VAS is a horizontal line of 100 mm in length. According to VAS, 0 mm is the lowest level and 100 mm is the highest level.

  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)

• Change in protect their physical privacy

  The level of protect their physical privacy they felt with the clothes they wore during mobilization.In this section, the degree of protect their physical privacy level will increase or decrease. This situation will be evaluated with the Visual Analog Scale (VAS). VAS is a horizontal line of 100 mm in length. According to VAS, 0 mm is the lowest level and 100 mm is the highest level.

  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)

• Change in satisfaction

  The level of satisfaction they felt with the clothes they wore during mobilization.In this section, the degree of satisfaction level will increase or decrease. This situation will be evaluated with the Visual Analog Scale (VAS). VAS is a horizontal line of 100 mm in length. According to VAS, 0 mm is the lowest level and 100 mm is the highest level.

  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)

• satisfaction level for the designed mobilization coverall

  It will be used to evaluate users' satisfaction for the designed mobilization coverall. This situation will be evaluated with the the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0).The survey questions, consisting of a total of 12 questions, are answered on a 5-point Likert scale, with higher scores indicating higher satisfaction (1=not satisfied at all, 5=very satisfied).

  It will be evaluated 30 minutes after the patients have experienced both clothing designs

Study Arms (2)

Intervention-Control:

ACTIVE COMPARATOR

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.

Other: Intervention-Control:

Control-Intervention:

SHAM COMPARATOR

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 coverall.

Other: Control-Intervention

Interventions

Intervention-Control: OTHER

Patients will complete the STAI before the first mobilization after surgery and then the patients' pain status and the level of anxiety they feel about their physical privacy with the mobilization coverall they will wear during mobilization will be assessed with the VAS.Than,will be asked to perform 4 activities (putting on the coverall-mobilization-sitting in the wheelchair and moving-taking off the coverall) with the overall.Than,will be asked to evaluate the indicator level that they think the coverall they wear protects physical privacy and the levels of comfort and satisfaction they feel about the coverall with the VAS.During the next mobilization,patients will be asked to perform the same application protocol with a traditional hospital gown.Participants who have tried both clothing designs will be interviewed about their experiences using 'interview form' their satisfaction.Than interview,participants will have completed the study by filling out the QUEST 2.0.

Also known as: Mobilization Coverall

Intervention-Control:

Control-Intervention OTHER

Patients will complete the STAI before the first mobilization after surgery and then the patients' pain status and the level of anxiety they feel about their physical privacy with the traditional hospital gown they will wear during mobilization will be assessed with the VAS.Than,will be asked to perform 4 activities (putting on the gown-mobilization-sitting in the wheelchair and moving-taking off the gown) with the gown.Than,will be asked to evaluate the indicator level that they think the gown they wear protects physical privacy, and the levels of comfort and satisfaction they feel about the gown with the VAS.During the next mobilization, patients will be asked to perform the same application protocol with the mobilization coverall.Participants who have tried both clothing designs will be interviewed about their experiences using 'interview form' their satisfaction.At the end of the interview, participants will have completed the study by filling out the QUEST 2.0.

Also known as: Traditional Hospital Gown

Control-Intervention:

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Kutahya City Hospital

Kütahya, Turkey (Türkiye)

Location

Related Publications (7)

• Jacofsky MC, Auran RL, Williams A, Mauro S, Sietsema D. Exposure-Related Anxiety and Improving Patient Satisfaction with Medical Undergarments During Surgery: A Randomized Controlled Trial. J Bone Joint Surg Am. 2022 Aug 3;104(15):1380-1385. doi: 10.2106/JBJS.22.00126. Epub 2022 Jun 20.

  PMID: 35726887 BACKGROUND

• Morton 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.

  PMID: 32314508 BACKGROUND

• 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.

  PMID: 36735235 BACKGROUND

• -Koç, Z., Bulut, S., Karaman, H. "Nursing Care According to the Functional Health Patterns Model in a Patient Diagnosed with Adolescent Idiopathic Scoliosis: Case Report". Anatolian Journal of Nursing and Health Sciences, 2019, 22(4), 319-330.

  BACKGROUND

• Frankel R, Peyser A, Farner K, Rabin JM. Healing by Leaps and Gowns: A Novel Patient Gowning System to the Rescue. J Patient Exp. 2021 Jul 21;8:23743735211033152. doi: 10.1177/23743735211033152. eCollection 2021.

  PMID: 34368427 BACKGROUND

• -Cho, K., "Redesigning hospital gowns to enhance end users' satisfaction". Family and Consumer Sciences Research Journal, 2006, 34(4), 332-349.

  BACKGROUND

• -Ağaç, S., Emiroğlu, S., "Design Application for the Improvement of Patient Gowns Used in Surgical Operations", International Journal of Cultural and Social Research, 2018, 4(Special Issue 3), 60-78.

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Hatice Ayhan, PhD

  University of Health Sciences Turkiye Gulhane Faculty of Nursing Ankara, Turkey

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 1, 2024
• Study Start: September 17, 2024
• Primary Completion: October 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 17, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)