Drawing Therapy for pReoperative Anxiety in Waiting (DRAW) (DRAW)

February 25, 2026 updated by: Zhihong LU

The Effect of Different Drawing Therapy on Preoperative Anxiety in Waiting Area

This study will use a factorial design to compare the effects of different colors and shapes on patients' preoperative anxiety.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

175

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients scheduled for elective surgery
  • age ≥18 yrs old

Exclusion Criteria:

  • Frail patients who can not freely sit on the seat
  • Patients with difficulty in communication
  • Patients with color vision deficiency
  • Patients with injury or neurological dysfunction influencing function of hand
  • Patients with severe vision deficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
warm color and sharp shape are shown to the patients
red and yellow color picture is used
triangle shaped picture is used
Experimental: B
warm color and smooth shape are shown to the patients
red and yellow color picture is used
circle and curve are used
Experimental: C
cold color and sharp shape are shown to the patients
triangle shaped picture is used
blue and green color is used
Experimental: D
cold color and smooth shape are shown to the patients
circle and curve are used
blue and green color is used
No Intervention: E

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
score of visual analogue scale (VAS) of anxiety
Time Frame: at the end of intervention, approximately 10 minutes before start of anesthesia
The Visual Analog Scale for Anxiety (VAS-A) is a single-item, quick-assessment tool consisting of a 100-mm horizontal line anchored by "no anxiety" at the left end (0 mm) and "worst possible anxiety" at the right end (100 mm). Patients were instructed to mark the point that best represented their current level of anxiety.
at the end of intervention, approximately 10 minutes before start of anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart rate variability
Time Frame: at the end of intervention, approximately 10 minutes before start of anesthesia
at the end of intervention, approximately 10 minutes before start of anesthesia
score of State-Trait Anxiety Inventory-State (STAI-S)
Time Frame: at the end of intervention, approximately 10 minutes before start of anesthesia
The State-Trait Anxiety Inventory-State (STAI-S) is a 20-item self-report questionnaire designed to assess transient or situational anxiety levels. Each item is rated on a 4-point Likert scale ranging from 1 ("not at all") to 4 ("very much so"), with total scores ranging from 20 to 80. Higher scores indicate higher levels of anxiety.
at the end of intervention, approximately 10 minutes before start of anesthesia
Engagement level during the painting task
Time Frame: from start of painting to end of painting , approximately 10 minutes
measured by a 0-10 subjective rating scale, 0 is not engaged, 10 is totally engaged
from start of painting to end of painting , approximately 10 minutes
tachycardia
Time Frame: from admitted into the operating room to start of anesthesia, at an average of 15 minutes
heart rate over 100 beats per minute
from admitted into the operating room to start of anesthesia, at an average of 15 minutes
hypertension
Time Frame: from admitted into the operating room to start of anesthesia, at an average of 15 minutes
systolic blood pressure increased by more than 20% of baseline. baseline blood pressure is measured in waiting area
from admitted into the operating room to start of anesthesia, at an average of 15 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individual preferences for colors and shapes
Time Frame: before intervention, approximately 30 minutes before anesthesia
1, prefer curve and warm color; 2, prefer angle and warm color; 3, prefer curve and cold color; 4, prefer angle and cold color
before intervention, approximately 30 minutes before anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

February 20, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJH-A-20260221

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data will be available after publication with reasonable request to Dr. Zhihong Lu.

IPD Sharing Time Frame

after publication

IPD Sharing Access Criteria

with reasonable request to Dr. Zhihong Lu

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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