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

The Impact of the Surgical Mask on the Relationship Between Patient and Family Nurse in Primary Care

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.

Study Overview

• Status: Unknown
• Conditions: Satisfaction, Personal
• Intervention / Treatment: Device: Mask; Procedure: Routine wound treatment

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal, 4200-450
    • CINTESIS - Faculty of Medicine of the University of Porto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensation of time	1 question asked about how long patients and nurses felt that the appointment lasted	1 day

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Investigators: Principal Investigator: Irene P Carvalho, PhD, CINTESIS, Faculty of Medicine, University of Porto

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 31, 2018
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: June 29, 2018
• First Submitted That Met QC Criteria: June 29, 2018
• First Posted (ACTUAL): July 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2018
• Last Update Submitted That Met QC Criteria: November 15, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: MASK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No