Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05919602 |
| Other study ID # |
EIRPA |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2023 |
| Est. completion date |
December 1, 2024 |
Study information
| Verified date |
July 2023 |
| Source |
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León |
| Contact |
M. Pérez Saavedra |
| Phone |
609088029 |
| Email |
mmperezsaa[@]saludcastillayleon.es |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Introduction: Current evidence supports the existence of preoperative anxiety and its
undesirable effects during surgery and in the postoperative period. Despite numerous studies
that have evaluated the effectiveness of different non-pharmacological interventions in
reducing preoperative anxiety, we have not found any that use an image catalog.
Objective: To evaluate the effect of an intervention based on the visualization of an image
catalog on the improvement of perceived anxiety in patients undergoing upper limb orthopedic
surgery.
Methodology: A prospective, randomized, controlled, parallel-group clinical trial with a 1:1
ratio will be conducted. The study will include 167 patients scheduled for upper limb surgery
who are over 18 years old, without blindness or decreased visual acuity that cannot be
corrected with appropriate lenses. The subjects will be invited to explain the study's
objective and perform baseline assessments. On the day of the surgical intervention, both
groups will receive standard care, but those in the intervention group will also visualize a
catalog of 8 images, 25 minutes before entering the operating room. In addition, 30 and 10
minutes before the intervention begins, all patients included in the study will have vital
signs taken, be administered Spielberger's anxiety scale, visual analog scale for anxiety,
and cortisol levels in saliva will be determined as measures of preoperative anxiety. The
final evaluation will measure whether this intervention results in decreased anxiety,
postoperative complications resulting from anxiety, and length of hospital stay.
Description:
1. Design:
This study will be a controlled and randomized clinical trial of two parallel groups
aimed at evaluating the effect of showing a catalog of 8 images in reducing perceived
anxiety in patients undergoing traumatic surgery of the upper limb.
2. Study setting:
The study will be carried out in the specialized care area, specifically in the surgical
block, in the Traumatology and Orthopedics Service of CAUSA (University Hospital Complex
of Salamanca, Spain).
3. Study subjects:
Participants will be selected in Traumatology consultations by consecutive sampling among
those who meet the selection criteria.
Inclusion criteria:
1. Individuals of both sexes over 18 years of age with upper limb pathology that will be
surgically treated at CAUSA.
2. Signed informed consent.
Exclusion criteria:
1. Pathology to be surgically treated with a location other than the upper limb.
2. Patients with a score of less than 26 points on the Mini Mental Examination (MMSE).
3. Blind or visually impaired individuals who cannot correct their vision with appropriate
lenses.
4. Any other circumstance at the discretion of the investigators.
4. Sample size: The final sample will consist of 167 subjects selected by simple random
sampling from the patients treated in the Traumatology consultation at CAUSA who are going to
undergo traumatic surgery of the upper limb.
These subjects will then be randomized in a ratio of 1:1 to control and intervention groups,
using Epidat 4.2 software.
The sample size has been estimated taking into account the main variable of the study:
reduction of preoperative anxiety according to the STAI scale, compared to standard care.
Since no studies evaluating the reduction of preoperative anxiety using image visualization
have been described, to calculate the sample size, we used the systematic review conducted by
Bradt et al. (19), which obtained a reduction of 6 points on the aforementioned scale using
another non-pharmacological method such as music therapy in reducing preoperative anxiety.
Accepting a risk α of 0.05 and a risk β of 0.2, with a standard deviation of 2.2 points, 152
subjects (76 in each group) are needed to detect a decrease of at least 1 point in the STAI
scale of the intervention group compared to the control group.
This estimate will be increased by 10% of subjects to cover possible losses throughout the
study.
5. Study variables: Sociodemographic variables: Information on age, gender, marital status,
educational level, with or without children, occupation, and employment status will be
collected from all participants. Additionally, the existence of comorbidities and personal
history, especially anxiety and depression, will be evaluated.
Clinical variables:
Blood pressure and heart rate: Blood pressure and heart rate will be measured in each
participant during the baseline visit, as well as 30 and 10 minutes before surgery. An OMRON
M10 IT® blood pressure monitor will be used, following current recommendations of the
European Society of Hypertension.
Stress response marker: Cortisol quantification will be performed using the Elecsys Cortisol
II Cobas® saliva test following the manufacturer's instructions (Roche). Three samples will
be collected from each patient, specifically, one on the day of the baseline visit and the
other two on the day of surgery, 30 and 10 minutes before entering the operating room.
Preoperative anxiety: This will be assessed using the Spanish validated version of the
State-Trait Anxiety Inventory (STAI) scale by Spielberger. The scale used in the study
distinguishes between anxiety as a state and anxiety as a personality trait. The scale
consists of 40 items, 20 of which evaluate anxiety as a trait (A/T) and the other 20 evaluate
anxiety as a state (A/S). State anxiety or momentary anxiety is characterized by subjectively
perceived feelings of tension and apprehension, as well as by hyperactivity of the autonomic
nervous system in response to a specific situation. In contrast, the characteristics of
anxiety as a trait predispose the subject to perceive the world in a certain way and to
manifest relatively stable response tendencies over time.
Participants are asked to respond to each item on a 3-point Likert scale. Then, the total
value is calculated (possible range 0-60 for each questionnaire). The full 20 items that
measure A/T and the 20 items that measure A/S will be administered during the baseline visit.
On the day of surgery, only the scale related to A/S will be applied.
Additionally, anxiety will also be evaluated through the Visual Analog Anxiety Scale (VAAS)
in adults, which consists of presenting a 100 mm line where the participant marks their level
of anxiety at that moment, with the left end valued as "no anxiety" and the right end as
"maximum anxiety". Similarly, it will be applied during the baseline visit and 30 and 10
minutes before entering the operating room on the day of surgery.
Procedure outcome variables: Complications derived from the procedure (pain and its control,
infections, length of hospital stay, etc.) will be reviewed to evaluate whether the
intervention reduces them.
6. Intervention performed:
Common intervention in both groups:
Participants will receive standard preoperative care.
Specific intervention in the experimental group:
Participants in the intervention group will be shown a catalog consisting of 8 images, each
for 8 seconds, 25 minutes before entering the operating room. The images shown will be
landscapes and/or objects of nature as an expression of neutrality, with light and soft
colors, and will be chosen by over 50% of the research team from a gallery of 20 possible
images that meet the aforementioned requirements.
7. Masking strategy: Due to the design of the study, the participant subjects and the person
responsible for showing the catalog of images cannot be blinded. However, those responsible
for analyzing the saliva samples and the statistician will be blinded.
8. Study procedure: Subjects who appear during the course of the study will be invited to
participate during the interview conducted in the traumatology clinic. Subjects who are
already on the waiting list for upper limb surgery will be invited to participate in the
study by phone. Subsequently, the researchers will contact interested individuals, explain
the purpose of the study, check inclusion and exclusion criteria, and arrange an interview.
At the baseline visit, the objective of the study, its procedures, risks, and expected
benefits will be explained again, and the patient information sheet will be handed over along
with the informed consent form. After signing the consent form, sociodemographic data,
medical history, presence of comorbidities, and use of concomitant medications will be
collected. In addition, cognitive performance, near visual acuity, anxiety as a personality
trait and situational state will be evaluated.
At the end of the baseline visit, randomization to one of the two study groups will be
performed. On the day of the surgical intervention, the degree of anxiety will be objectively
and subjectively assessed 30 and 10 minutes before the operation for all patients.
Participants in the intervention group will be shown the images 25 minutes before the
operation, after the first vital signs are taken, saliva sample is collected, and the
previously described scales are applied.
9. Statistical analysis: The normality of the variables will be assessed using the
Kolmogorov-Smirnov test. Continuous variables will be expressed as mean ± standard deviation
and qualitative variables will be expressed as number and percentage. The chi-square test
will be used to analyze the association between independent qualitative variables, and the
McNemar test will be used for paired samples. Comparison of means between two groups will be
carried out using Student's t-test or the non-parametric Mann-Whitney U test. Change within
the same group will be evaluated using a Student's t-test or the Wilcoxon test. The
relationship between quantitative variables will be analyzed using the Pearson coefficient or
the Spearman correlation coefficient, as appropriate. Multivariate analysis will be performed
using different multiple logistic regression models to analyze the effect of the
intervention. In all cases, variables that may influence the outcome, such as
sociodemographic variables, drug use, presence of comorbidities, etc., will be adjusted. A
bilateral hypothesis test with a risk alpha of 0.05 will be set as the limit of statistical
significance. SPSS, v.25.0 will be used for the statistical analysis of the data.
10. Ethical Issues: After obtaining authorization from the Clinical Research Ethics Committee
of the Salamanca health area and having previously informed the study participants, the study
will be carried out in compliance with the principles of the Helsinki Declaration.
Information about the project's objectives, as well as the expected benefits and risks, will
be made known to the participants, and all of this will be reflected in the informed consent.
Participants' confidentiality will be guaranteed at all times in accordance with the Organic
Law on the Protection of Personal Data and Guarantee of Digital Rights, LO 3/2018 of December
5, and under the conditions established by the Law on Biomedical Research 14/2007.
11. Gender Perspective: In our study, the inclusion of women in the research team has been
taken into account, with women making up 60% of the team. Similarly, women over the age of 18
who meet the requirements to participate in the study and voluntarily accept to participate
are included in the study population.
