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NCT Number: NCT07117578

Preoperative Anxiety in Eastern Nepal (PAEN)

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.

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Key information

Conditions

Preoperative Anxiety Clinician Attention Elective Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Om Sai Pathibhara Hospital and Provincial hospital Bhadrapur

Bhadrapur, Koshi, 57200, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18-80 years
  • Scheduled for elective surgery with prior pre-anesthetic clearance
  • Able to provide informed consent

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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,

Secondary outcomes

  1. Clinician Anxiety Rating Score vs. Amsterdam Preoperative Anxiety and Information Scale

    Time frame: Single preoperative assessment before surgery

    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).

  2. Anxiety Associations with Demographic & Clinical Factors

    Time frame: Single preoperative assessment before Surgery

    Variables: Age, gender, marital status, occupation, education, ASA PS, prior surgery/anesthesia, anesthesia type, region of residence

    Statistical Analysis: Logistic regression

Sponsors and collaborators

Lead sponsor

Tribhuvan University Teaching Hospital, Institute Of Medicine.

Other

Registry information

Official study title

Assessment of Preoperative Anxiety in Adult Patient Undergoing Elective Surgery in Eastem Sub-urban Area ofNepa

Acronym: PAEN

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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