Satisfaction, PersonalNCT03584685
Impact of the Surgical Mask on the Patient-nurse Relation in Primary Care
A study testing Mask and Routine wound treatment in people with Satisfaction, Personal, run by Universidade do Porto at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Satisfaction, Personal
- What is being tested?
- Mask and Routine wound treatment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePortugal
- Study dates
- 31 Jan 2018to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Failing to meet the above criteria
Trial locations and contacts
1 site in 1 country.
Portugal1 site
CINTESIS - Faculty of Medicine of the University of Porto
Porto, 4200-450
About this study
Official title: 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.
Read the 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.
- Conditions
- Satisfaction, Personal
- Being tested
- Mask, Routine wound treatment
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaskDevice
All participants will initially be treated without the mask. In the next appointment, half will be treated with the mask.
Routine wound treatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| With Mask | Experimental | Use of the surgical mask in one routine wound treatment appointment. Receives: Device: Mask |
| Without Mask | Active comparator | Routine wound treatment appointment without nurses wearing the surgical mask. Receives: Procedure: Routine wound treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (1)
Sensation of time
1 question asked about how long patients and nurses felt that the appointment lasted
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start31 Jan 2018
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Satisfaction, PersonalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irene P Carvalho, PhD, Principal investigator, CINTESIS, Faculty of Medicine, University of Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584685
- Sponsor's protocol ID
- MASK
- Status last verified
- Jun 2018
- First submitted
- 29 Jun 2018
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Surgical Mask on the Relationship Between Patient and Family Nurse in Primary Care
- ClinicalTrials.gov ID
- NCT03584685
- Acronym / sponsor ID
- MASK
- Conditions
- Satisfaction, Personal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 12 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| With Mask | Experimental | Device: MaskUse of the surgical mask in one routine wound treatment appointment. |
| Without Mask | Active comparator | Procedure: Routine wound treatmentRoutine wound treatment appointment without nurses wearing the surgical mask. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Failing to meet the above criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MaskAll participants will initially be treated without the mask. In the next appointment, half will be treated with the mask. | Device | With Mask |
| Routine wound treatmentAll 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. | Procedure or surgery | Without Mask |
Primary outcome
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.
1 secondary outcome
Sensation of time
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene P Carvalho, PhD principal investigator
CINTESIS, Faculty of Medicine, University of Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mask and Routine wound treatment in people with Satisfaction, Personal, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-item questionnaire assessing patient satisfaction with the nurse-patient relation (the PSQ-III) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2018.