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Effectiveness of Images in Reducing Preoperative Anxiety

NCT05919602 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2025-03-25

No results posted yet for this study

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.

Conditions

  • Upper Limb Injury

Interventions

OTHER

Visualization of an image catalogue

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.

Sponsors & Collaborators

  • Instituto de Investigación Biomédica de Salamanca

    collaborator OTHER

  • María del Mar Perez Saavedra

    lead OTHER

Principal Investigators

  • M. Pérez Saavedra · GERENCIA REGIONAL DE SALUD CASTILLA Y LEÓN

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-03-01
Completion
2027-05-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05919602 on ClinicalTrials.gov