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Impact of the Surgical Mask on the Patient-nurse Relation in Primary Care

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ClinicalTrials.gov Identifier: NCT03584685
Recruitment Status : Active, not recruiting
First Posted : July 12, 2018
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Universidade do Porto

Brief 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.

Condition or disease Intervention/treatment Phase
Satisfaction, Personal Device: Mask Procedure: Routine wound treatment Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: All participants will initially be treated without the surgical mask. Then, half will be treated with the mask and the other half will be treated without the mask.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Participants are blind as to whether they are in the control or experimental groups. The investigators and outcomes assessors are blind to which patients received the intervention.
Primary Purpose: Treatment
Official Title: The Impact of the Surgical Mask on the Relationship Between Patient and Family Nurse in Primary Care
Actual Study Start Date : January 31, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: With Mask
Use of the surgical mask in one routine wound treatment appointment.
Device: Mask
All participants will initially be treated without the mask. In the next appointment, half will be treated with the mask.

Active Comparator: Without Mask
Routine wound treatment appointment without nurses wearing the surgical 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.




Primary Outcome Measures :
  1. 30-item questionnaire assessing patient satisfaction with the nurse-patient relation (the PSQ-III) [ Time Frame: 1 day ]
    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.


Secondary Outcome Measures :
  1. Sensation of time [ Time Frame: 1 day ]
    1 question asked about how long patients and nurses felt that the appointment lasted



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584685


Locations
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Portugal
CINTESIS - Faculty of Medicine of the University of Porto
Porto, Portugal, 4200-450
Sponsors and Collaborators
Universidade do Porto
Investigators
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Principal Investigator: Irene P Carvalho, PhD CINTESIS, Faculty of Medicine, University of Porto

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Responsible Party: Universidade do Porto
ClinicalTrials.gov Identifier: NCT03584685     History of Changes
Other Study ID Numbers: MASK
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No