Preoperative Anxiety in Eastern Nepal (PAEN)

NCT07117578 | Completed

• 2 other identifiers: NHRC-562/2024562/2024
• Study Type: observational
• Target: 422
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Preoperative Anxiety; Elective Surgery; Clinician Attention

Keywords

APAIS; Clinician Rated Score; Clinician reported anxiety; Elective Surgery; Preoperative Anxiety

Outcome Measures

Primary Outcomes (1)

• 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,

  Single preoperative assessment before surgery

Secondary Outcomes (2)

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

  Single preoperative assessment before surgery

• Anxiety Associations with Demographic & Clinical Factors

  Single preoperative assessment before Surgery

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tribhuvan University Teaching Hospital, Institute Of Medicine.: lead

Study Sites (1)

Om Sai Pathibhara Hospital and Provincial hospital Bhadrapur

Bhadrapur, Koshi, 57200, Nepal

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anesthesiologist

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: August 12, 2025
• Study Start: March 19, 2025
• Primary Completion: July 5, 2025
• Study Completion: July 15, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)