Effectiveness of a Nursing Intervention on Pre-surgical Anxiety

NCT ID: NCT07309458

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 314 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-02
• Study Completion Date: 2025-10-15

Brief Summary

Preoperative anxiety is a very common experience among surgical patients. Many people scheduled for Day Surgery (Ambulatory Major Surgery, AMS) experience worry, tension, or fear while waiting to enter the operating room. This anxiety is not incidental; numerous studies have shown that it can influence pain perception, postoperative recovery, and overall satisfaction with the surgical procedure. Despite its relevance, routine clinical practice does not always include structured interventions to help patients manage these feelings in the moments immediately before surgery. Due to their close and continuous role throughout the surgical process, nursing professionals are key in providing this type of support.

This clinical study is being conducted at Hospital de la Malvarrosa (Valencia) and focuses on adult patients scheduled for AMS across different surgical specialties, including Otorhinolaryngology, Maxillofacial Surgery, General Surgery, and Urological Surgery. Its aim is to provide a clear, evidence-based answer to the following question: can an individualized nursing intervention applied in the immediate preoperative period reduce anxiety levels and improve the patient's overall surgical experience? The study hypothesis proposes that a brief, personalized intervention delivered by nursing staff-based on empathic communication, tailored information, and simple coping techniques-can help patients manage preoperative anxiety and positively influence their perception of the surgical process.

To test this hypothesis, the study compares two groups of patients undergoing AMS. The control group receives standard preoperative care, which includes clinical preparation and the basic information routinely provided before surgery. The intervention group, in contrast, receives an additional individualized nursing intervention lasting approximately 15-20 minutes in the preoperative area, carried out alongside routine preparation procedures such as intravenous cannulation, medication administration, or surgical checklist verification. During this process, the nurse creates a trusting environment, encourages patients to express their fears, validates their emotions, provides clear and understandable explanations of the different stages of the procedure, and teaches simple breathing and emotional regulation techniques.

Anxiety levels are assessed using a validated clinical scale that measures both physical and emotional symptoms related to anxiety. Assessment takes place in the immediate preoperative period, allowing for an objective comparison between the control and intervention groups. In addition, the study collects data on personal, social, and surgical variables that may influence anxiety, with the aim of better understanding which patient profiles are more vulnerable and which benefit most from the intervention.

Although the primary approach of the study is quantitative, a qualitative perspective is also incorporated to explore the subjective experiences of both patients and nursing staff.

Overall, this study aims to demonstrate that a humanized, structured, and evidence-based nursing intervention can significantly reduce preoperative anxiety in AMS and improve the surgical experience. Furthermore, it seeks to contribute knowledge that supports the development of more comprehensive care protocols in which patients' emotional well-being is considered an essential component of surgical preparation.

Conditions

Pre Surgical Anxiety

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

Control Group without nursgin intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Intervention Group with nursing intervention

Group Type: EXPERIMENTAL

Nursing Intervention

Intervention Type: BEHAVIORAL

Specific Nursing Intervención to reduce pre surgical anxiety based on Nursing Intervention Taxonomy (NIC)

Interventions

Nursing Intervention

Specific Nursing Intervención to reduce pre surgical anxiety based on Nursing Intervention Taxonomy (NIC)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients over 18 years old.
• Voluntary participation and informed consent to participate in the study.
• Individuals scheduled for major outpatient surgical procedures in operating rooms 5 and 6 of La Malvarrosa Hospital

Exclusion Criteria

• Patients with comprehension difficulties (hearing loss, language barrier, or insufficient cognitive level).
• Patients with temporarily impaired cognitive ability (premedicated with benzodiazepines)
• Clinical situations that prevented participation in data collection.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Elena Violeta Iborra Palau

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Malvarrosa

Valencia, Valencia, Spain

Countries

Spain

Other Identifiers

2024.044

Identifier Type: -

Identifier Source: org_study_id