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

NCT05639621 | Completed DMC

• 1 other identifier: University of Concepcion
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Significant accompaniment; anxiety; nursing; endoscopy

Outcome Measures

Primary Outcomes (1)

• Decrease 5 points on the anxiety scale. The preferred format is to use outcome-neutral language in Outcome Measure Title and Description (e.g., "change" instead of "decrease"). Please review and revise as appropriate.

  Patients who have a significant accompaniment structured follow-up have less 5 points on the anxiety scale compared to patients who did not have the intervention, with 0 points until 60 points and higher scores indicate a worse result.

  60 minutes measured before and after endoscopic procedure

Secondary Outcomes (3)

• Mantainance or not increase of Psychological parameters

  30 minutes measured during the endoscopic procedure

• Maintenance or not increase of physiological parameters

  60 minutes measured three times (before, during and after endoscopic procedure)

• Maintenance or not increase of Biochemical parameters

  60 minutes measured two times (before and after endoscopic procedure)

Other Outcomes (1)

• Maintenance o not increase of mechanical parameters

  60 minutes (after endoscopic procedure)

Study Arms (2)

Meaningful accompaniment

EXPERIMENTAL

Patient who is going to undergo an endoscopic procedure and who will have a significant accompaniment by a person freely chosen by the patient and who will escort him in a visual and tactile way during the pre-procedure, intra-procedure, and post-procedure endoscopic stage.

Procedure: Accompaniment

Usual care

NO INTERVENTION

Patient who is going to undergo an endoscopic procedure and who receives regular care provided by the service during the pre-procedure, intra-procedure and post-procedure stage.

Interventions

Accompaniment PROCEDURE

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

Meaningful accompaniment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age.
• Patients who can read and write
• Patient who is the first endoscopy to undergo
• Patient 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 voluntarily

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Concepcion: lead

Study Sites (1)

Hospital de Tome

Tomé, Concepcion, 4030000, Chile

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Andrea Rodríguez

  Universidad de Concepcion

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: October 16, 2021
• First Posted: December 6, 2022
• Study Start: January 4, 2021
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2022
• Last Updated: December 6, 2022

Record last verified: 2022-11

Locations

CL (1)