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Pre Surgical AnxietyNCT07309458

Effectiveness of a Nursing Intervention on Pre-surgical Anxiety

A study testing Nursing Intervention in people with Pre Surgical Anxiety, run by University of Valencia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pre Surgical Anxiety
What is being tested?
Nursing Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
314 participants
Where
1 siteSpain
Study dates
2 May 2024to 15 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hospital Malvarrosa

    Valencia, Valencia, 46011

Other trials in Spain

About this study

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.

Read more

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.

Being tested
Nursing Intervention
Keywords
pre surgical anxiety, Nursing intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nursing InterventionBehavioural

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

Study groups in NCT07309458
Study groupRoleWhat they receive
ControlNo interventionControl Group without nursgin intervention
InterventionExperimentalIntervention Group with nursing intervention
Receives: Behavioral: Nursing Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Anxiety Severity assessed by the Hamilton Anxiety Rating Scale (HAM-A)

    The HAM-A consists of 14 items that measure both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (very severe). The total score ranges from 0 to 56, obtained by summing the scores of all 14 items. Higher scores indicate higher levels of anxiety (worse outcome). Scores are interpreted as follows: 0-17 (mild anxiety), 18-24 (moderate anxiety), 25-30 (severe anxiety), and >30 (very severe anxiety).

    Measured: Baseline (upon a arrival at holding area) and inmediatly post nursing intervention (approximately 20 minutes after baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2025
  2. Study start2 May 2024
  3. Primary completion15 Sep 2025
  4. Study completion15 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Experimental study with a control group of nursing intervention
Masking
None (open label)
Enrolment
314 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07309458
Sponsor's protocol ID
2024.044
Status last verified
Dec 2025
First submitted
15 Dec 2025
Last updated
6 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The anonymized database from the study will be shared via the Zenodo platform. Initially, the data will remain hidden and will only be shared once the study has been published.

Questions about this trial

What is this clinical trial studying?

A study testing Nursing Intervention in people with Pre Surgical Anxiety, run by University of Valencia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Anxiety Severity assessed by the Hamilton Anxiety Rating Scale (HAM-A) (time frame: Baseline (upon a arrival at holding area) and inmediatly post nursing intervention (approximately 20 minutes after baseline)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.

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