NCT05639621: MMEANS

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

Completed NA Last updated 6 December 2022

What this trial tests

NA trial testing Accompaniment in Anxiety State in 126 participants. Completed in 30 July 2022.

Timeline

4 January 2021

Primary endpoint
30 July 2021

30 July 2022

Quick facts

Lead sponsor	Universidad de Concepcion
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	126
Start date	4 January 2021
Primary completion	30 July 2021
Estimated completion	30 July 2022
Sites	1 location across Chile

Drugs / interventions tested

• Accompaniment

Conditions studied

• Anxiety State — all drugs for Anxiety State →

Sponsor

Universidad de Concepcion — full company profile →

Who can join

Adults 18 to 85, any sex, with Anxiety State. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.