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

NCT03584685 | Unknown

• 1 other identifier: MASK
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Satisfaction, Personal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sensation of time

  1 day

Study Arms (2)

With Mask

EXPERIMENTAL

Use of the surgical mask in one routine wound treatment appointment.

Device: Mask

Without Mask

ACTIVE COMPARATOR

Routine wound treatment appointment without nurses wearing the surgical mask.

Procedure: Routine wound treatment

Interventions

Mask DEVICE

All participants will initially be treated without the mask. In the next appointment, half will be treated with the mask.

With Mask

Routine wound treatment PROCEDURE

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.

Without Mask

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Failing to meet the above criteria

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

CINTESIS - Faculty of Medicine of the University of Porto

Porto, 4200-450, Portugal

Location

MeSH Terms

Conditions

Personal Satisfaction

Interventions

Masks

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Irene P Carvalho, PhD

  CINTESIS, Faculty of Medicine, University of Porto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 12, 2018
• Study Start: January 31, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 16, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)