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Management of Meaningful Accompaniment to Reduce Patient Anxiety in Endoscopic Procedures: Randomized Clinical Trial

NCT05639621 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2022-12-06

No results posted yet for this study

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.

Conditions

  • Anxiety State

Interventions

PROCEDURE

Accompaniment

presence of a person freely chosen by the patient, who will escort in a visual and tactile way during the endoscopic procedure

Sponsors & Collaborators

  • Universidad de Concepcion

    lead OTHER

Principal Investigators

  • Andrea Rodríguez · Universidad de Concepcion

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-04
Primary Completion
2021-07-30
Completion
2022-07-30

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05639621 on ClinicalTrials.gov