Instituto de Investigación Biomédica de Salamanca - IBSAL

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.

This Phase IIB, multicenter, double-blind, randomized, and uncontrolled clinical trial aims to assess the efficacy and safety of subconjunctival injection of Mesenchymal Stem Cells (MSCs) in patients with Graft-versus-Host Disease (GVHD) and severe ocular involvement (DYD-dry eye disease). The primary objective is to evaluate the clinically and statistically significant improvement in the signs and symptoms associated with the disease.
Secondary objectives include:
* Analyzing adverse events related to the subconjunctival injection of MSCs to confirm the safety of this treatment in patients with GVHD ocular involvement.
* Identifying new biomarkers that can be used to objectively assess the progression of patients with GVHD and severe ocular involvement.
* Studying the relationship between the expression of ocular surface-specific markers by MSCs and their clinical efficacy, as well as the variation in the expression of these markers in relation to cell preservation methods.
Assessing the quality of life of patients treated with two doses of MSCs using the NEI VFQ-25 (National Eye Institute Visual Function Questionnaire).
- Evaluating whether the cell dose impacts clinical improvement.
The trial includes 30 patients, divided into two groups of 15, and focuses on the assessment of dry eye disease, with the treatment based on MSC administration to improve clinical outcomes and quality of life for the patients.

Introduction. At the neurophysiological level, it is possible to observe an increase in the central processing of pain in patients diagnosed with persistent Spinal Pain Syndrome (PSPS-T1/2), potentially stemming from dysfunctions in the endogenous facilitation and inhibition of pain. Administration of high doses of spinal cord stimulation to individuals with PSPS-T1/2 may induce supraspinal descending activation. Similarly, exercise is recognized as a fundamental aspect of spinal pain management. Studies have demonstrated its impact on neurophysiological factors, including the release of spinal and supraspinal beta-endorphins, which activate μ-opioid receptors. Therefore, the purpose of this study will be to examine the effect of SCS in combination with lumbo-pelvic stability core training on perceived low back pain, quality of life and disability in failed back surgery syndrome (FBSS) patients. Methods/Materials. A double-blind randomized clinical trial (RCT) has been designed. All participants will be randomized from a pre-set sequence. The intervention design has been elaborated from the CONSORT guidelines. This study protocol has been approved by the Ethics Committee in research of Salamanca Health Area (protocol number PI 2023 101435 in (24/01/2024) in accordance with the ethical guidelines of the Helsinki declaration. Sample size was calculated using G Power® Sample size software (University of Düsseldorf). The calculation was based on a moderate effect size of 0.4 (partial η2 = 0.40, α = .05, power = 0.90), resulting in a total of 28 patients. Assuming a 30% dropout rate, 36 participants will be recruited in total. Two sessions per week will be scheduled for 8 weeks with a total of 16 sessions. Each work session will have a duration of 60 minutes. The exercise will be adapted according to the phases based on the results already published, limiting in each phase the degrees of flexion and extension of the spine in order to avoid the risk of electrode migration. Primary outcomes will be functionality, satisfaction, strength, psychosocial variables, quality of life and pain perception.