Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05639621 |
| Other study ID # |
University of Concepcion |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 4, 2021 |
| Est. completion date |
July 30, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
Universidad de Concepcion |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
The study is a clinical trial, with random assignment to two groups: control and
experimental, that is, the study corresponds to a Design with Pretest-Postest and Control
Group. The sample will be made up of all the patients who will undergo an endoscopy procedure
in a public hospital, during the first quarter of the year 2021 and the intervention will be
the significant accompaniment that the patient who is going to undergo an endoscopic
procedure of the group will have experimental (EG) in the pre-procedure stage - during the
procedure and after the procedure, while the control group (CG) will receive the usual care
of the service under study, that is, without a significant companion.
DESCRIPTION OF THE STAGES OF THE INTERVENTION
1. - PRE PROCEDURE PERIOD
1. Mediate: Due to the COVID-19 pandemic contingency, it is necessary to adopt the
necessary security measures before, during and after conducting the interview with
the patient who is going to undergo an endoscopic procedure. In this context, in
the mediate preoperative period, to inform the patient that he is going to undergo
an endoscopic procedure, non-face-to-face interviews will be promoted, through the
use of electronic means, through videoconferencing, recorded telephone calls or
emails, if the patient so requires, as well as conducting face-to-face interviews
according to the protocols provided for it. The selected patients will be contacted
by the coordinating nurse 3 or 4 days in advance, informing them that they must
approach the emergency service to take PCR test (to detect COVID-19, this telephone
contact will be the one that the responsible researcher will use to propose the
voluntary participation in the study. If approved, the nursing professional
responsible for the study will request the signing of the informed consent on the
day the patient and companion attend to take the PCR test.
PROTOCOL SIGNATURE INFORMED CONSENT NOT PRESENTIAL
To carry out this procedure, the following protocol will be followed with each of
the patients and significant companions that will make up the study sample:
1. Patient identification by name.
2. Identification of the responsible researcher.
3. Presentation of the research project.
4. Request to approve recording of informed consent and / or sociodemographic
data.
5. Reading informed consent
6. Request for clarification of doubts.
7. Completion of the interview and acknowledgments.
PROTOCOL SIGNATURE INFORMED CONSENT IN PERSON To carry out this procedure, the
following protocol will be followed with each of the patients and significant
companions that will make up the study sample.
1. The interview will be carried out in an individual and well ventilated room.
2. The following should be considered in the interview:
- Avoid physical contact when greeting and maintain a social distance of 1
meter between the responsible researcher and the patient interviewed.
- Hand hygiene with soap and water and / or alcohol gel solution after
interview.
- Use of personal protection elements (PPE): Use a surgical type mask that
covers the nose and mouth, replace the mask each time it gets wet -
dispose of the mask once removed in a garbage can with a lid.
3. Patient identification by name
4. Identification of the responsible researcher
5. Presentation of the research project
6. Request to approve recording of informed consent and / or sociodemographic
data
7. Reading informed consent and request for sociodemographic data (Annex 4)
8. Request for clarification of doubts
9. End of interview and acknowledgments
10. Hand hygiene with soap and water and / or alcohol gel solution after the
interview
10) Cleaning of the place where the meeting was held after it was concluded 11)
Keep the names, identification and telephone numbers of the interviewee for at
least one month
INTERVIEW ROOM CLEANING AND DISINFECTION PROCEDURE Before carrying out the
disinfection of the interview room, a surface cleaning process must be carried out,
by removing organic and inorganic matter, usually by friction, with the help of
detergents used in the establishment under study, subsequently rinsing with water
to eliminate dirt by dragging.
Once the cleaning process has been carried out, the already clean surfaces must be
disinfected, with the application of disinfectant products used by the service
under study through the use of sprinklers, towels, fiber or microfiber cloths or
mops.
2. Inmediate: the day of the endoscopic procedure, the significant person will be
received by the clinical nurse, who will be in charge of:
- Give general and specific instructions on the procedure.
- Hand hygiene with soap and water.
- Delivery of costumes to enter at endoscopic procedure room. The significant
companion will be next to the patient in the pre-procedure room and both will
be accompanied by the nursing professional in charge of managing this
monitoring, who will measure the patient the following parameters:
Psychological, physiological, biochemical parameters.
2. - INTRAPROCEDURE PERIOD. Once the patient is on the endoscopic procedure table, the
significant companion follows the instructions of the nursing professional, who leaves
it on the patient's right side, takes the patient's hand for the duration of the
sedation procedure. In this stage, after sedation, the responsible endoscopy medical
professional will be asked for authorization to apply the Anxiety Assessment Scale
(VAS), after which the investigated patient is asked to indicate the intensity of the
sensation by placing a line at across the line, representing the intensity of the
sensation at that moment. Once the patient is under sedation, the significant companion
follows the instructions of the nursing professional, who tells to leave and accompanies
the way to the waiting room.
3. - POSTPROCEDURE PERIOD. After sedation recovery, the nursing professional supervises the
hygiene of the significant companion's hands, then leaves at the side of the patient's
unit, will take the patient's hand until he regains consciousness. The nursing
professional will measure the psychological-physiological-biochemical parameters. In
this last stage, a variable that measures mechanical parameters will be incorporated,
that is, the respiratory and body movements that the patient has in the post-sedation
stage.
INTERVENTION IN CONTROL GROUP WILL CONSIST OF THE FOLLOWING STAGES:
I.- Preprocedure Period
1. Mediate Preoperative: In this context COVID-19, in the mediate preoperative period, to
inform the patient that he is going to undergo a surgical procedure, non-face-to-face
interviews will be promoted, through the use of electronic means, through
videoconferencing, recorded telephone calls or e-mails, if the patient requires it, as
well as conducting face-to-face interviews according to the protocols provided for it.
The protocol for signing informed consent not in person and in person will be carried
out in both groups.
2. Immediate: On the day of the endoscopic procedure, the patient will be accompanied by
the nursing professional in charge of managing this monitoring, who will measure the
following parameters: Psychological, physiological, biochemical parameters.
II.- Intraprocedure period After sedation, authorization will be requested from the
responsible endoscopy medical professional to apply the Anxiety Assessment Scale (VAS),
before which the investigated patient is asked to indicate the intensity of the sensation by
placing a line through of the scale, which represents the intensity of anxiety at that
moment.
III.- Postprocedure Period Once the patient has recovered from sedation, the evaluator will
measure the psychological -physiological-biochemical parameters.
In this last stage, a variable that measures mechanical parameters will be incorporated, that
is, the respiratory and body movements that the post-sedation patient has.
SAMPLE SIZE CALCULATION The statistical program Epidat 3.1 was used to calculate the sample
size of the study. To carry out this procedure, the estimates from other studies were used,
with a standard deviation of 10.4 for the STAY scale, with a difference of 5 points as
clinically relevant. The level of significance was set at 0.05 (5%), a ratio between the
means of 1, with a power of 80%. After entering the data into the software, the finally
suggested sample is 126 patients, a number that is weighted to admit 10% of dropouts or
withdrawals from the study, completing a sample size to be selected of 139 patients. From the
definitive sample size (n = 126), the experimental group (n = 63) and the control group (n=
63) were finally formed.
DESCRIPTIVE ANALYSIS The data obtained will be analyzed through the SPSS statistical program.
For the analysis of the data obtained, a statistical evaluation will be carried out by
objectives, which will include, firstly, descriptive analysis through frequency tables and
graphs, and secondly, obtaining statistics such as mean, standard deviation, coefficient of
variation, maximum and minimum.
INFERENTIAL ANALYSIS FOR THE TEST OF HYPOTHESIS. For the development of this experimental
study (intervention in a treatment group and counterfactual in a control group), the
difference-in-difference method will be used, by means of the T-Student test. In this case,
the comparisons are of three types.
First, the means of the control and experimental groups are compared in the baseline period,
where it is expected that there are no significant differences. With this evaluation it is
hoped to prove that both groups are homogeneous prior to the intervention.
Secondly, within each group, the means obtained in different periods (Preprocedure,
Intraprocedure and Postprocedure) are compared, expecting that the control and experimental
groups present a different behavior, in particular, that the eventual increases in the
anxiety-related variables are lower in the experimental group compared to the control group.
Third, the means for the Preprocedure-Intraprocedure and Postprocedure periods are compared
between the control and experimental groups, where better results are expected in the
experimental group.
