Preoperative Anxiety in Eastern Nepal (PAEN)

Tribhuvan University Teaching Hospital, Institute Of Medicine.

Status: Completed

Conditions: Elective Surgery; Clinician Attention; Preoperative Anxiety

Study type: Observational

Funder types: Other

Identifiers

NCT07117578

562/2024 (Other Identifier)

NHRC-562/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 422 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

422 participants in 1 patient group

Adult Elective Surgery Patients

Description:

Adult Elective Surgery Patients in Eastern Suburban Nepal presenting for elective surgery after preoperative anaesthetic checkup and clearance and perioperative counseling.