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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03584685
Other study ID # MASK
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 31, 2018
Est. completion date December 2018

Study information

Verified date June 2018
Source Universidade do Porto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study is to inspect the effect of nurses wearing the surgical mask on their patients' satisfaction with the relationship. All participants will initially be treated without the mask. Then, half will be treated with the mask and the other half will be treated without the mask.


Description:

The use of the surgical mask has well-known benefits for both the patient and the professional regarding the control of infection contamination. However, its use is left to individual criteria, and is passed on from generation to generation of nurses through experiential, intuitive knowledge. Studies are necessary to support the use of the surgical mask.

Research indicates that wearing the mask affects perception of words, thus influencing patient-nurse communication. However, it might also affect the very nurse--patient relation. For example, it can convey the idea of personal distancing, which can either be appreciated by patients as dutiful professional care by the nurse, or viewed as a limit imposed on interpersonal communication and on the relationship.

This study inspects patient satisfaction about (1) interpersonal aspects and (2) professionalism in the patient-nurse relationship when the mask is used.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 150
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients suffering from chronic wounds

- Age: 18 years or older

- Know how to read and write in Portuguese

- Confirmed autopsychic and allopsychic orientation

- Maintain previous relation with the nurse of at least 18 months

- Need at least two consecutive treatments with the nurse

Exclusion Criteria:

- Failing to meet the above criteria

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Mask
All participants will initially be treated without the mask. In the next appointment, half will be treated with the mask.
Procedure:
Routine wound treatment
All participants will initially be treated for their wounds without the mask. In the next appointment, half will again be treated for their wounds without the mask.

Locations

Country Name City State
Portugal CINTESIS - Faculty of Medicine of the University of Porto Porto

Sponsors (1)

Lead Sponsor Collaborator
Universidade do Porto

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary 30-item questionnaire assessing patient satisfaction with the nurse-patient relation (the PSQ-III) Self-reported patient satisfaction after one appointment with the nurse about interpersonal aspects of the patient-nurse relation (7 items), communication (5 items) and nurse's technical quality (10 items). Responses are given on a 1 to 5 Likert scale. Higher scores correspond to greater satisfaction. 1 day
Secondary Sensation of time 1 question asked about how long patients and nurses felt that the appointment lasted 1 day
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