FearPOSPoFeNCT06785389
Influence of Preoperative Fear on Pain and Postoperative Outcomes
An observational study of Fear and Pain Management, run by Hospital Universitario de Gran Canaria Doctor Negrín at 1 site in Spain.
Trial summary
Fear of anesthesia plays a crucial role in the perioperative setting and can negatively affect recovery. The main objective is to assess the relationship between fear of anesthesia, surgeries, and hospitals and poorer postoperative pain control in patients undergoing scheduled surgery, as well as to relate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fear, Pain Management, Anxiety
- What is being tested?
- Fear of anesthesia, surgery and hospitals scale, State-Trait Anxiety Inventory and Nummerical Rating Scale for postoperative pain
- How many people
- 138 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jan 2025to 15 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: All patients undergoing scheduled surgery with general anesthesia requiring hospital admission during the study period.
Who may be able to join
- All patients older than 18 years old scheduled for surgery with admission during the study period will be included.
- Verbal and written informed consent.
Who cannot join
- Minors
- Cognitive impairment
- Patients not being able to understand and respond to preoperative questionnaires
- Patients not being able to respond to postoperative pain assessment
- Patients not giving informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, Las Palmas, 35002
Ángel Becerra-Bolaños, MD PhD, 676229025, angbecbol@gmail.com
About this study
Fear of anesthesia plays a crucial role in the perioperative setting and can negatively affect recovery. The main objective is to assess the relationship between fear of anesthesia, surgeries, and hospitals and poorer postoperative pain control in patients undergoing scheduled surgery, as well as to relate preoperative anxiety to postoperative analgesic assessment in this population.
This is a prospective observational study including 138 patients scheduled for surgery.
Read the detailed description
Fear is a response that arises in the face of immediate threats, such as medical procedures, while anxiety is related to uncertainty about treatment and prognosis. These factors can negatively affect recovery. Assessing anxiety levels using specific tools may be essential to predict clinical outcomes and facilitate patient recovery after surgery.
This prospective observational study will assess the relationship between fear of anesthesia, surgeries, and hospitals and poorer postoperative pain control in patients undergoing scheduled surgery. It will also relate preoperative anxiety to postoperative analgesic assessment in this population.
Disease or disorder under study: Fear of anesthesia and postoperative pain control using two preoperative questionnaires. Patients will be followed up until discharge to assess postoperative pain and postoperative outcomes. Considering that the estimated percentage of fear is around 10%, with a 95% confidence interval and a 5% error margin, 138 patients are needed to accurately estimate its prevalence in the population.
- Being tested
- Fear of anesthesia, surgery and hospitals scale, State-Trait Anxiety Inventory, Nummerical Rating Scale for postoperative pain
- Keywords
- preoperative fear, postoperative pain, postoperative outcomes, preoperative anxiety
- Medical subject headings
- Agnosia, Anxiety Disorders, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fear of anesthesia, surgery and hospitals scaleDiagnostic test
The day before surgery, patients will be interviewed using the scales of Fear of anesthesia, surgery and hospitals.
State-Trait Anxiety InventoryDiagnostic test
The day before surgery, patients will be interviewed using the State-Trait Anxiety Inventory
Nummerical Rating Scale for postoperative painDiagnostic test
Also called Nummerical Rating Scale
In the first postoperative day, patients will be monitored using the Nummerical Rating Scale, which will assess postoperative pain.
| Study group | Role | What they receive |
|---|---|---|
| Patients scheduled for surgery | Patients undergoing surgery under general anesthesia with hospital admission. Receives: Diagnostic Test: Fear of anesthesia, surgery and hospitals scale; Diagnostic Test: State-Trait Anxiety Inventory; Diagnostic Test: Nummerical Rating Scale for postoperative pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain using Nummerical Rating Scale
In the first postoperative day, patients will be monitored using the Nummerical Rating Scale, which will assess postoperative pain, from 0 (no pain) to 10 (maximum pain)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start22 Jan 2025
- Primary completion30 Nov 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FearStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor Negrín
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ángel Becerra-Bolaños, MD PhD, Hospital Universitario de Gran Canaria Doctor Negrín
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785389
- Sponsor's protocol ID
- 2024-472-1
- Acronym
- POSPoFe
- Status last verified
- Aug 2025
- First submitted
- 16 Jan 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Preoperative Fear on Pain and Postoperative Outcomes
- ClinicalTrials.gov ID
- NCT06785389
- Acronym / sponsor ID
- POSPoFe / 2024-472-1
- Keywords
- preoperative fear, postoperative pain, postoperative outcomes, preoperative anxiety
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor NegrínUniversity, hospital or other
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 21 Jan 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.
Fear of anesthesia plays a crucial role in the perioperative setting and can negatively affect recovery. The main objective is to assess the relationship between fear of anesthesia, surgeries, and hospitals and poorer postoperative pain control in patients undergoing scheduled surgery, as well as to relate preoperative anxiety to postoperative analgesic assessment in this population.
This is a prospective observational study including 138 patients scheduled for surgery.
Detailed description
Fear is a response that arises in the face of immediate threats, such as medical procedures, while anxiety is related to uncertainty about treatment and prognosis. These factors can negatively affect recovery. Assessing anxiety levels using specific tools may be essential to predict clinical outcomes and facilitate patient recovery after surgery.
This prospective observational study will assess the relationship between fear of anesthesia, surgeries, and hospitals and poorer postoperative pain control in patients undergoing scheduled surgery. It will also relate preoperative anxiety to postoperative analgesic assessment in this population.
Disease or disorder under study: Fear of anesthesia and postoperative pain control using two preoperative questionnaires. Patients will be followed up until discharge to assess postoperative pain and postoperative outcomes. Considering that the estimated percentage of fear is around 10%, with a 95% confidence interval and a 5% error margin, 138 patients are needed to accurately estimate its prevalence in the population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients scheduled for surgery | – | Diagnostic Test: Fear of anesthesia, surgery and hospitals scale, Diagnostic Test: State-Trait Anxiety Inventory, Diagnostic Test: Nummerical Rating Scale for postoperative painPatients undergoing surgery under general anesthesia with hospital admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing scheduled surgery with general anesthesia requiring hospital admission during the study period.
Key inclusion criteria (2 listed)
- All patients older than 18 years old scheduled for surgery with admission during the study period will be included.
- Verbal and written informed consent.
Key exclusion criteria (5 listed)
- Minors
- Cognitive impairment
- Patients not being able to understand and respond to preoperative questionnaires
- Patients not being able to respond to postoperative pain assessment
- Patients not giving informed consent.
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 |
|---|---|---|
| Fear of anesthesia, surgery and hospitals scaleThe day before surgery, patients will be interviewed using the scales of Fear of anesthesia, surgery and hospitals. | Diagnostic test | Patients scheduled for surgery |
| State-Trait Anxiety InventoryThe day before surgery, patients will be interviewed using the State-Trait Anxiety Inventory | Diagnostic test | Patients scheduled for surgery |
| Nummerical Rating Scale for postoperative painAlso: Nummerical Rating ScaleIn the first postoperative day, patients will be monitored using the Nummerical Rating Scale, which will assess postoperative pain. | Diagnostic test | Patients scheduled for surgery |
Primary outcome
Postoperative pain using Nummerical Rating Scale
Time frame: 24 hours
In the first postoperative day, patients will be monitored using the Nummerical Rating Scale, which will assess postoperative pain, from 0 (no pain) to 10 (maximum pain)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fear and Pain Management, run by Hospital Universitario de Gran Canaria Doctor Negrín 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 24 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ángel Becerra Bolaños, MD PhD (676229025, angbecbol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain using Nummerical Rating Scale (time frame: 24 hours). 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 24 Aug 2025.