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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Pre Surgical Anxiety
- 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 group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control Group without nursgin intervention |
| Intervention | Experimental | Intervention 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.
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.
- First posted30 Dec 2025
- Study start2 May 2024
- Primary completion15 Sep 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre Surgical AnxietyStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Violeta Iborra Palau, University of Valencia
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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Nursing Intervention on Pre-surgical Anxiety
- ClinicalTrials.gov ID
- NCT07309458
- Acronym / sponsor ID
- 2024.044
- Conditions
- Pre Surgical Anxiety
- Keywords
- pre surgical anxiety, Nursing intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental study with a control group of nursing intervention
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control Group without nursgin intervention |
| Intervention | Experimental | Behavioral: Nursing InterventionIntervention Group with nursing intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nursing InterventionSpecific Nursing Intervención to reduce pre surgical anxiety based on Nursing Intervention Taxonomy (NIC) | Behavioural | Intervention |
Primary outcome
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)
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.