Preoperative Anxiety in Eastern Nepal (PAEN)

NCT ID: NCT07117578

Last Updated: 2025-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

422 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-19

Study Completion Date

2025-07-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Preoperative Anxiety Elective Surgery Clinician Attention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tribhuvan University Teaching Hospital, Institute Of Medicine.

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sujan Dhakal, MD

Consultant Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Om Sai Pathibhara Hospital and Provincial hospital Bhadrapur

Bhadrapur, Koshi, Nepal

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Nepal

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

562/2024

Identifier Type: OTHER

Identifier Source: secondary_id

NHRC-562/2024

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Improving Perioperative Sleep Disorders
NCT06512155 COMPLETED PHASE1