NCT07639437

Brief Summary

The goal of this clinical trial is to learn whether preprocedural video education can reduce anxiety in adult patients who are scheduled to undergo bronchoscopy under general anesthesia. It will compare video-based education with standard verbal education. The main questions it aims to answer are: Does video education reduce preprocedural anxiety, as measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS), in patients undergoing bronchoscopy under general anesthesia? Researchers will compare patients who receive audiovisual education with those who receive standard verbal education to see whether video education provides greater anxiety reduction before bronchoscopy under general anesthesia. Participants will:

  1. 1.Complete an APAIS questionnaire before receiving preprocedural education
  2. 2.Receive either video-based education using a tablet or standard verbal education with a question-and-answer session
  3. 3.Complete another APAIS questionnaire immediately after the education session

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 5, 2026

Last Update Submit

June 5, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pre-education total APAIS score

    The pre-education total APAIS score was assessed before any educational intervention was delivered, using the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The APAIS consists of six items scored on a 5-point Likert scale, ranging from 1 ("not at all") to 5 ("extremely"), with higher total scores indicating greater preprocedural anxiety and information need.

    single time point immediately before education

  • Post-education total APAIS score

    The pre-education total APAIS score was assessed before any educational intervention was delivered, using the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The APAIS consists of six items scored on a 5-point Likert scale, ranging from 1 ("not at all") to 5 ("extremely"), with higher total scores indicating greater preprocedural anxiety and information need.

    single time point immediately after education

Study Arms (2)

control group

ACTIVE COMPARATOR

Participants in the control group received standard preprocedural education through verbal explanation and a question-and-answer session delivered by the anesthesiologist. The education was based on the standard anesthesia education materials used at RSUP Persahabatan. APAIS scores were assessed before and immediately after the education session.

Behavioral: Verbal only

intervention group

EXPERIMENTAL

Participants in the intervention group received standard preprocedural verbal education and a question-and-answer session delivered by the anesthesiologist. In addition, they received audiovisual education through a video presented on a tablet. The video provided information about bronchoscopy under general anesthesia. APAIS scores were assessed before and immediately after the education session.

Behavioral: Verbal + Audiovisual educational video

Interventions

Participants received standard preprocedural verbal education and a question-and-answer session delivered by the anesthesiologist. In addition, participants watched an audiovisual educational video about bronchoscopy under general anesthesia on a tablet. The video was designed to provide consistent information about the procedure and anesthesia process, improve patient understanding, and reduce preprocedural anxiety. The APAIS questionnaire was completed before and immediately after the education session.

intervention group
Verbal onlyBEHAVIORAL

Participants received standard preprocedural education through verbal explanation and a question-and-answer session delivered by the anesthesiologist. The education was based on the standard anesthesia education materials used at RSUP Persahabatan and provided information about bronchoscopy under general anesthesia. The APAIS questionnaire was completed before and immediately after the verbal education session.

control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients aged ≥18 years who are scheduled to undergo bronchoscopy under general anesthesia.
  • Patients with no previous history of medical procedures performed under general anesthesia.
  • Patients with an American Society of Anesthesiologists (ASA) physical status classification of I-III.
  • Patients who are willing to participate in the study and have provided written informed consent.

You may not qualify if:

  • Patients who are unable to read and write.
  • Patients with significant hearing and/or visual impairment.
  • Patients with cognitive or mental disorders identified from the patient's medical record.
  • Patients with a history of antipsychotic or benzodiazepine use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RSUP Persahabatan

Jakarta, Jakarta Special Capital Region, 13230, Indonesia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2026

First Posted

June 10, 2026

Study Start

July 1, 2025

Primary Completion

October 30, 2025

Study Completion

October 30, 2025

Last Updated

June 10, 2026

Record last verified: 2026-06

Locations