Nurse's RoleNCT03512561
Impact of the Presurgical Visit of Nursing on the Well-being of the Surgical Patient.
An observational study of Nurse's Role and Preoperative Care, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
.A surgical intervention involves the participant and his / her family in a very stressful situation with a biopsychosocial alteration of the participant, often presenting a lack of knowledge of the surgical process from admission to hospital discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nurse's Role, Preoperative Care, Patient Satisfaction
- How many people
- 356 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2018to 1 Oct 2020
- Phase
- Observational
- 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
Study population: All the patients who are going to be operated
Who may be able to join
- Patients who have undergone the pre-surgical nursing visit (personalized).
- Patients over 18 years of age
- Live accompanied and / or with own resources of help.
- Having signed the informed consent.
Who cannot join
- Not having signed the informed consent.
- Not having done the questionnaires after pre-surgical nursing visit (STAI, EQ-5D-5L)
- For surgical complications that do not allow the telephone survey, or focal groups.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Presurgical Visit of Nursing on the Well-being of the Patient Before a Surgical Process at the Parc Taulí Health Corporation.
.A surgical intervention involves the participant and his / her family in a very stressful situation with a biopsychosocial alteration of the participant, often presenting a lack of knowledge of the surgical process from admission to hospital discharge. Researchers (nursing) began to make prior visits to the surgical procedure to reduce anxiety and provide information about the surgical process. The importance of the presurgical nursing visit (PNV) is sought, how to achieve a better health education throughout the surgical process, improve communication between professionals through standardized records, contributing to an optimal approach to the participant, increasing well-being, health and the satisfaction of the participant
Read the detailed description
In our Center, PNVs are carried out in the Ambulatory Area (External Consultations) in a specific and personalized nursing consultation, within an established and multidisciplinary program. One week before surgery, the patient and a family / primary caregiver are cited.
The PNV conducts a semi-structured interview; the content may vary according to the type of surgery, but in general it can be understood as all those nursing interventions; how to provide information, support, advice and training to the patient and his family (primary caregiver).
It is an innovative experience since it has been carried out for a short time. The PNV have been gradually restructured and continue to grow, since their establishment has been positively valued in the different services thanks to the experience gained and the numerous bibliographic references that demonstrate the beneficial results for the patient and the health system.
A total of 356 participants have been calculated (surveys answered in more than 3 months), taking into account an approximate population of 1,172 programmed interventions carried out in 1 year, with a confidence interval of 95%, accuracy of 3% a proportion of 5% and with an expected loss of 15%.
Sample:
Arthralplasia of knee / hip N 480 n 92 Cystectomies N 24 n 19 Esophagogastric with coloplasty N 24 n 19 Hysterectomy N 24 n 19 Colon / rectum N 192 n 65 Lumpectomy with sentinel lymph nodes N 222 n 74 Caesarean section N 206 n 68
- Conditions
- Nurse's Role, Preoperative Care, Patient Satisfaction
- Medical subject headings
- Patient Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
The participant is satisfied throughout the surgical process, in relation to information, health education and personalized attention to the presurgical nursing visit (PNV)
Number of participants who are satisfied with the experience of the surgical procedure and if this is what is explained in the presurgical nursing visit, for the evaluation of the importance of the visit in the surgical process.
Measured: 3 months
Secondary outcomes (3)
The participant feels well-being due to the care received by the professionals throughout the surgical process.
Number of participants who perceive welfare linked to the quality of care of the surgical process.
Measured: 3 month
The participant has preoperative and postoperative anxiety in more than three months, relating it to the information provided in the presurgical nursing visit.
Number of participants who perceive pre and postsurgical anxiety and if it is linked to the information provided during the visit.
Measured: 3 months
The participant perceives better quality of presurgical and postoperative life in more than three months; in relation to the training given during the pre-surgical nursing visit.
Number of participants who perceive an improvement in the quality of life and if it is linked to the information provided during the visit.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start1 Feb 2018
- Primary completion10 Sep 2019
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Zamora Carmona, Corporacion Parc Tauli
- Investigators
- Francesc Zamora-Carmona, Nurse, Principal investigator, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512561
- Sponsor's protocol ID
- EST-VPI-2017
- Status last verified
- Jul 2021
- First submitted
- 8 Mar 2018
- Last updated
- 28 Jul 2021
- 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 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Presurgical Visit of Nursing on the Well-being of the Patient Before a Surgical Process at the Parc Taulí Health Corporation.
- ClinicalTrials.gov ID
- NCT03512561
- Acronym / sponsor ID
- EST-VPI-2017
- Conditions
- Nurse's Role, Preoperative Care, Patient Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 30 Apr 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.
.A surgical intervention involves the participant and his / her family in a very stressful situation with a biopsychosocial alteration of the participant, often presenting a lack of knowledge of the surgical process from admission to hospital discharge. Researchers (nursing) began to make prior visits to the surgical procedure to reduce anxiety and provide information about the surgical process. The importance of the presurgical nursing visit (PNV) is sought, how to achieve a better health education throughout the surgical process, improve communication between professionals through standardized records, contributing to an optimal approach to the participant, increasing well-being, health and the satisfaction of the participant
Detailed description
In our Center, PNVs are carried out in the Ambulatory Area (External Consultations) in a specific and personalized nursing consultation, within an established and multidisciplinary program. One week before surgery, the patient and a family / primary caregiver are cited.
The PNV conducts a semi-structured interview; the content may vary according to the type of surgery, but in general it can be understood as all those nursing interventions; how to provide information, support, advice and training to the patient and his family (primary caregiver).
It is an innovative experience since it has been carried out for a short time. The PNV have been gradually restructured and continue to grow, since their establishment has been positively valued in the different services thanks to the experience gained and the numerous bibliographic references that demonstrate the beneficial results for the patient and the health system.
A total of 356 participants have been calculated (surveys answered in more than 3 months), taking into account an approximate population of 1,172 programmed interventions carried out in 1 year, with a confidence interval of 95%, accuracy of 3% a proportion of 5% and with an expected loss of 15%.
Sample:
Arthralplasia of knee / hip N 480 n 92 Cystectomies N 24 n 19 Esophagogastric with coloplasty N 24 n 19 Hysterectomy N 24 n 19 Colon / rectum N 192 n 65 Lumpectomy with sentinel lymph nodes N 222 n 74 Caesarean section N 206 n 68
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients who are going to be operated
Key inclusion criteria (4 listed)
- Patients who have undergone the pre-surgical nursing visit (personalized).
- Patients over 18 years of age
- Live accompanied and / or with own resources of help.
- Having signed the informed consent.
Key exclusion criteria (3 listed)
- Not having signed the informed consent.
- Not having done the questionnaires after pre-surgical nursing visit (STAI, EQ-5D-5L)
- For surgical complications that do not allow the telephone survey, or focal groups.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The participant is satisfied throughout the surgical process, in relation to information, health education and personalized attention to the presurgical nursing visit (PNV)
Time frame: 3 months
Number of participants who are satisfied with the experience of the surgical procedure and if this is what is explained in the presurgical nursing visit, for the evaluation of the importance of the visit in the surgical process.
3 secondary outcomes
The participant feels well-being due to the care received by the professionals throughout the surgical process.
Time frame: 3 month
The participant has preoperative and postoperative anxiety in more than three months, relating it to the information provided in the presurgical nursing visit.
Time frame: 3 months
The participant perceives better quality of presurgical and postoperative life in more than three months; in relation to the training given during the pre-surgical nursing visit.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- 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.
Francesc Zamora-Carmona, Nurse principal investigator
Corporacion Parc Tauli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nurse's Role and Preoperative Care, run by Corporacion Parc Tauli at 1 site in Spain.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 28 Jul 2021. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The participant is satisfied throughout the surgical process, in relation to information, health education and personalized attention to the presurgical nursing visit (PNV) (time frame: 3 months). 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 28 Jul 2021.