Effectiveness of Images in Reducing Preoperative Anxiety

NCT05919602 | Not Yet Recruiting DMC

• 1 other identifier: EIRPA
• Study Type: interventional
• Target: 167
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Anxiety level (STAI)

  The anxiety level in both groups of patients will be measured and assessed. the validated Spanish version of Trait Anxiety Inventory will be used as an anxiety measurement scale (STAI). The scale consists of 40 items, 20 measure anxiety-trait and the other 20 anxiety-state. The minimum score is 0 points (no anxiety) and the maximum is 60 (maximum level of anxiety)

  1 year

Study Arms (2)

Control group

NO INTERVENTION

Subjects on the waiting list for upper limb surgery that on the day of surgery, only anxiety will be evaluated before the operation and no intervention would be performed before the operation.

Intervention group

EXPERIMENTAL

Subjects on the waiting list for upper limb surgery on the day of surgery, anxiety will be evaluated before the operation and intervention would be performed before the operation.

Other: Visualization of an image catalogue

Interventions

Visualization of an image catalogue OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals of both sexes over 18 years of age with upper limb pathology that will be surgically treated at the University hospital complex in Salamanca.
• Signed informed consent.

You may not qualify if:

• Pathology to be surgically treated with a location other than the upper limb.
• Patients with a score of less than 26 points on the Mini Mental Examination (MMSE).
• Blind or visually impaired individuals who cannot correct their vision with appropriate lenses.
• Any other circumstance at the discretion of the investigators

Sponsors & Collaborators

• María del Mar Perez Saavedra: lead
• Instituto de Investigación Biomédica de Salamanca: collaborator

MeSH Terms

Conditions

Arm Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• M. Pérez Saavedra

  GERENCIA REGIONAL DE SALUD CASTILLA Y LEÓN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

M. Pérez Saavedra

CONTACT

609088029; mmperezsaa@saludcastillayleon.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: June 26, 2023
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share