Management of Meaningful Accompaniment to Reduce Patient Anxiety in Endoscopic Procedures: Randomized Clinical Trial
Condition: Anxiety State
MeSH terms: Anxiety Disorders
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Accompaniment
Intervention type(s): Procedure
Intervention description(s): presence of a person freely chosen by the patient, who will escort in a visual and tactile way during the endoscopic procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Significant accompaniment; anxiety; nursing; endoscopy