← Back to all trials
Completed
NCT05639621
Management of Meaningful Accompaniment to Reduce Patient Anxiety in Endoscopic Procedures: Randomized Clinical Trial
Conditions: Anxiety State
Sex: All
Ages: 18 Years – 85 Years
Phase: NA
Enrollment: 126
Sponsor: Universidad de Concepcion
Location: Chile
Summary
An upper digestive endoscopy diagnostic procedure is undoubtedly a situation that will generate anxiety.
The environment, protocols, distance the patient from the family member or partner, which is perceived as a threat to integrity.
The objective of the study is to determine the effectiveness of a structured, significant follow-up nursing intervention to reduce anxiety in patients who are going to undergo upper digestive endoscopy in a public hospital in the Biobío Region, year 2021.
The methodological proposal will be in a randomized, single-blind, third-party evaluation clinical trial, the intervention will consist of the visual and tactile presence of a significant companion throughout the endoscopic procedure.
The sample will be 126 that will make up the experimental and control group.
It is hypothesized that patients who have a significant follow-up will obtain 10 points less on the anxiety scale compared to those who did not have the intervention.
The data will be collected with the Spielberg state / anxiety test (STAIT) and the Visual Analog Scale (VAS) to measure psychological effects, with vital parameters (pressure, pulse, respiration, saturometry), physiological effects, as well as the effects biochemicals with blood levels of potassium, glycemia and cortisol in saliva and mechanical effects through the monitoring of movements, using a mesh of pressure sensors.
The difference-in-difference statistical method will be applied by t student, to analyze the data.
The requirements of Emmanuel will be applied to safeguard the ethics of the study.
It is hoped that significant follow-up as a nursing intervention will be shown to reduce the anxiety of the patient who is going to undergo an endoscopic procedure.
Eligibility Criteria
Inclusion Criteria:Patients over 18 years of age.Patients who can read and writePatient who is the first endoscopy to undergoPatient who in previous hospitalizations have had no incidents.Patient participating throughout the surgical stage with a significant companion.Spanish speaking patients.Patients living in the Bío-Bío Region.Patients who have signed informed consent and agreed to participate voluntarilyExclusion Criteria:Patients older than 85 years.Patients with psychiatric disorders.Patients with severe sensory alterations or disabilities that make the interview difficult.Patients with alterations or injuries in the hands that hinder sensitivity.Patients with treatments with sedatives and / or NSAIDs, since their use could affect blood pressure.
Source: ClinicalTrials.gov (NCT05639621). StuddyBuddy aggregates publicly available trial information.