NCT07309458

Effectiveness of a Nursing Intervention on Pre-surgical Anxiety

Completed NA Last updated 6 January 2026

What this trial tests

NA trial testing Nursing Intervention in Pre Surgical Anxiety in 314 participants. Completed in 15 October 2025.

Timeline

2 May 2024

Primary endpoint
15 September 2025

15 October 2025

Quick facts

Lead sponsor	University of Valencia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	314
Start date	2 May 2024
Primary completion	15 September 2025
Estimated completion	15 October 2025
Sites	1 location across Spain

Drugs / interventions tested

• Nursing Intervention

Conditions studied

• Pre Surgical Anxiety — all drugs for Pre Surgical Anxiety →

Sponsor

University of Valencia

Who can join

18 and older, any sex, with Pre Surgical Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.