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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03512561
Other study ID # EST-VPI-2017
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2018
Est. completion date October 1, 2020

Study information

Verified date July 2021
Source Corporacion Parc Tauli
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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


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


Recruitment information / eligibility

Status Completed
Enrollment 356
Est. completion date October 1, 2020
Est. primary completion date September 10, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Spain Corporació Sanitària Parc Taulí Sabadell Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 months
Secondary 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. 3 month
Secondary 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. 3 months
Secondary 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. 3 months
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