Preoperative AnxietyPAENNCT07117578
Preoperative Anxiety in Eastern Nepal (PAEN)
An observational study of Preoperative Anxiety and Elective Surgery, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
Trial summary
This study is looking at how many adults feel nervous or worried before planned surgery at two hospitals in eastern Nepal. We will include men and women aged 18 to 80 who are having elective operations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Preoperative Anxiety, Elective Surgery, Clinician Attention
- How many people
- 422 participants
- Where
- 1 siteNepal
- Study dates
- 19 Mar 2025to 15 Jul 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will involve adult patients (18 years and older) scheduled for elective surgical procedures under general, regional, or combined anesthesia at Bhadrapur Provincial Hospital and Om Sai Pathibhara Hospital in Eastern Suburban Nepal. Recruitment will occur over four months using consecutive sampling. Eligible patients must be classified as American Society of Anesthesiologists (ASA) physical status I-III, able to communicate in Nepali or English, and willing to provide written informed consent.
Who may be able to join
- Adults aged 18-80 years
- Scheduled for elective surgery with prior pre-anesthetic clearance
- Able to provide informed consent
Who cannot join
- Decline to participate
- Documented psychiatric disorders or cognitive impairment
- Current treatment with anxiolytics or antidepressants
- Language barrier preventing questionnaire completion
- ASA Physical Status IV or higher
Trial locations and contacts
1 site in 1 country.
Nepal1 site
Om Sai Pathibhara Hospital and Provincial hospital Bhadrapur
Bhadrapur, Koshi, 57200
About this study
Official title: Assessment of Preoperative Anxiety in Adult Patient Undergoing Elective Surgery in Eastem Sub-urban Area ofNepa
This study is looking at how many adults feel nervous or worried before planned surgery at two hospitals in eastern Nepal. We will include men and women aged 18 to 80 who are having elective operations.
On the day of the preoperative check, the participant will be asked to complete a very short, six-question survey about how anxious the participant feels and how much information the participant wants. It takes about five minutes, and the participant can answer by choosing responses like "not at all," "somewhat," or "extremely."
Read more
The investigating anesthesiologist will also make a quick, private note of how anxious they think you are based on their routine pre-anaesthesia check. All of the participant answers and the doctor's note will be kept strictly confidential and stored securely.
Joining the study is entirely voluntary. Deciding not to take part or choosing to leave the study at any time will not change the medical care you receive. There are no extra costs or medical tests beyond what you would normally have.
By sharing your experience, the participant helps us understand what makes patients feel anxious before surgery and how the investigators can improve support and information for future patients.
Read the detailed description
This is a cross-sectional observational study conducted at Bhadrapur Provincial Hospital and Om Sai Pathibhara Hospital. We aim to enrol 422 adult patients (18-80 years old) with ASA physical status I to III scheduled for elective surgery.
The investigator will use the Amsterdam Preoperative Anxiety and Information Scale (APAIS) to measure patient-reported anxiety and information need. This six-item tool yields an anxiety score (4-20 points) and an information-need score (2-10 points). A score of 11 or more indicates high anxiety. In addition, the attending anesthesiologist will rate each patient's anxiety immediately after the pre-anaesthetic check.
We will collect demographic and clinical data, including age, gender, marital status, education level, occupation, previous anaesthesia exposure, type of anaesthesia, and area of residence. Data entry will be done in Excel, and analysis will be carried out using SPSS. We will report median and interquartile ranges for APAIS scores and use multivariable logistic regression to identify factors associated with high anxiety.
The study protocol has been approved by the Nepal Health Research Council. Participant confidentiality will be maintained through coded identifiers, locked physical records, and encrypted digital files.
The investigator's goal is to determine how common preoperative anxiety is and which patient characteristics influence it. The findings will guide the development of targeted interventions and information programmes to reduce anxiety before surgery.
- Conditions
- Preoperative Anxiety, Elective Surgery, Clinician Attention
- Keywords
- APAIS, Clinician Rated Score, Clinician reported anxiety, Elective Surgery, Preoperative Anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult Elective Surgery Patients | Adult Elective Surgery Patients in Eastern Suburban Nepal presenting for elective surgery after preoperative anaesthetic checkup and clearance and perioperative counseling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Anxiety Prevalence
Assessment Tool: Amsterdam Preoperative Anxiety and Information Scale (APAIS) to measure patient-reported anxiety and information need. This six-item tool yields an anxiety score (4-20 points) and an information-need score (2-10 points).
Definition: Amsterdam Preoperative Anxiety and Information Scale, total anxiety score ≥11,
Measured: Single preoperative assessment before surgery
Secondary outcomes (2)
Clinician Anxiety Rating Score vs. Amsterdam Preoperative Anxiety and Information Scale
Comparison of the anesthesiologist's subjective rating (CRS), which is a similar scale to APAIS to measure anxiety and information need by the anesthesiologist according to the patient's answer and other objective variables from attached monitors. This six-item tool yields an anxiety score (4-20 points) and an information-need score (2-10 points).
Measured: Single preoperative assessment before surgery
Anxiety Associations with Demographic & Clinical Factors
Variables: Age, gender, marital status, occupation, education, ASA PS, prior surgery/anesthesia, anesthesia type, region of residence
Statistical Analysis: Logistic regression
Measured: Single preoperative assessment before Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start19 Mar 2025
- Primary completion5 Jul 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 422 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sujan Dhakal, MD, Tribhuvan University Teaching Hospital, Institute Of Medicine.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117578
- Sponsor's protocol ID
- NHRC-562/2024
- Other IDs
- 562/2024
- Acronym
- PAEN
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Preoperative Anxiety in Adult Patient Undergoing Elective Surgery in Eastem Sub-urban Area ofNepa
- ClinicalTrials.gov ID
- NCT07117578
- Acronym / sponsor ID
- PAEN / NHRC-562/2024
- Conditions
- Preoperative Anxiety, Elective Surgery, Clinician Attention
- Keywords
- APAIS, Clinician Rated Score, Clinician reported anxiety, Elective Surgery, Preoperative Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 422 participants (actual)
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.University, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 5 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 12 Aug 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.
This study is looking at how many adults feel nervous or worried before planned surgery at two hospitals in eastern Nepal. We will include men and women aged 18 to 80 who are having elective operations.
On the day of the preoperative check, the participant will be asked to complete a very short, six-question survey about how anxious the participant feels and how much information the participant wants. It takes about five minutes, and the participant can answer by choosing responses like "not at all," "somewhat," or "extremely."
The investigating anesthesiologist will also make a quick, private note of how anxious they think you are based on their routine pre-anaesthesia check. All of the participant answers and the doctor's note will be kept strictly confidential and stored securely.
Joining the study is entirely voluntary. Deciding not to take part or choosing to leave the study at any time will not change the medical care you receive. There are no extra costs or medical tests beyond what you would normally have.
By sharing your experience, the participant helps us understand what makes patients feel anxious before surgery and how the investigators can improve support and information for future patients.
Detailed description
This is a cross-sectional observational study conducted at Bhadrapur Provincial Hospital and Om Sai Pathibhara Hospital. We aim to enrol 422 adult patients (18-80 years old) with ASA physical status I to III scheduled for elective surgery.
The investigator will use the Amsterdam Preoperative Anxiety and Information Scale (APAIS) to measure patient-reported anxiety and information need. This six-item tool yields an anxiety score (4-20 points) and an information-need score (2-10 points). A score of 11 or more indicates high anxiety. In addition, the attending anesthesiologist will rate each patient's anxiety immediately after the pre-anaesthetic check.
We will collect demographic and clinical data, including age, gender, marital status, education level, occupation, previous anaesthesia exposure, type of anaesthesia, and area of residence. Data entry will be done in Excel, and analysis will be carried out using SPSS. We will report median and interquartile ranges for APAIS scores and use multivariable logistic regression to identify factors associated with high anxiety.
The study protocol has been approved by the Nepal Health Research Council. Participant confidentiality will be maintained through coded identifiers, locked physical records, and encrypted digital files.
The investigator's goal is to determine how common preoperative anxiety is and which patient characteristics influence it. The findings will guide the development of targeted interventions and information programmes to reduce anxiety before surgery.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Elective Surgery Patients | – | –Adult Elective Surgery Patients in Eastern Suburban Nepal presenting for elective surgery after preoperative anaesthetic checkup and clearance and perioperative counseling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will involve adult patients (18 years and older) scheduled for elective surgical procedures under general, regional, or combined anesthesia at Bhadrapur Provincial Hospital and Om Sai Pathibhara Hospital in Eastern Suburban Nepal. Recruitment will occur over four months using consecutive sampling. Eligible patients must be classified as American Society of Anesthesiologists (ASA) physical status I-III, able to communicate in Nepali or English, and willing to provide written informed consent.
Key inclusion criteria (3 listed)
- Adults aged 18-80 years
- Scheduled for elective surgery with prior pre-anesthetic clearance
- Able to provide informed consent
Key exclusion criteria (5 listed)
- Decline to participate
- Documented psychiatric disorders or cognitive impairment
- Current treatment with anxiolytics or antidepressants
- Language barrier preventing questionnaire completion
- ASA Physical Status IV or higher
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Preoperative Anxiety Prevalence
Time frame: Single preoperative assessment before surgery
Assessment Tool: Amsterdam Preoperative Anxiety and Information Scale (APAIS) to measure patient-reported anxiety and information need. This six-item tool yields an anxiety score (4-20 points) and an information-need score (2-10 points). Definition: Amsterdam Preoperative Anxiety and Information Scale, total anxiety score ≥11,
2 secondary outcomes
Clinician Anxiety Rating Score vs. Amsterdam Preoperative Anxiety and Information Scale
Time frame: Single preoperative assessment before surgery
Anxiety Associations with Demographic & Clinical Factors
Time frame: Single preoperative assessment before Surgery
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 12 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Preoperative Anxiety
Recruiting
Preoperative Music Intervention for Anxiety in Hip and Knee Arthroplasty
Anxiety, Osteoarthritis
Not yet recruitingPhase 4
Effect of Midazolam Given at Induction on Recall of Propofol Injection Pain
Propofol Injection Pain, Postoperative Recall of Pain
RecruitingObservational study
Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
Preoperative Anxiety, Orthopedic Surgery
Not yet recruiting
Virtual Reality to Reduce Anxiety During Thoracic Epidural Placement.
Preoperative Anxiety Score
Recruiting
Positive Affirmations and Preoperative Anxiety
Total Joint Replacement Surgery, Preoperative Anxiety
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?
An observational study of Preoperative Anxiety and Elective Surgery, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
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 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: finished, as of the sponsor's last update on 12 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 Nepal. 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?
Preoperative Anxiety Prevalence (time frame: Single preoperative assessment before surgery). 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 12 Aug 2025.