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

September 11, 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

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
272

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A
warm color and sharp shape are shown to the patients
Behavioral: warm color
red and yellow color picture is used
Behavioral: sharp shape
triangle shaped picture is used
Experimental: B
warm color and smooth shape are shown to the patients
Behavioral: warm color
red and yellow color picture is used
Behavioral: smooth shape
circle and curve are used
Experimental: C
cold color and sharp shape are shown to the patients
Behavioral: sharp shape
triangle shaped picture is used
Behavioral: cold color
blue and green color is used
Experimental: D
cold color and smooth shape are shown to the patients
Behavioral: smooth shape
circle and curve are used
Behavioral: cold color
blue and green color is used

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
heart rate
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 visual analogue scale (VAS) of anxiety
Time Frame: Before anesthesia induction, approximately 1 minute 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.
Before anesthesia induction, approximately 1 minute before start of anesthesia
Visual analogue score of sleep quality
Time Frame: at 24 hours after surgery
Visual analogue score of sleep quality is from 0 to 10, 0 is the worst quality, 10 is the best quality
at 24 hours after surgery
Score of satisfaction to anesthesia
Time Frame: at 24 hours after surgery
Score of satisfaction to anesthesia is from 0 to 10, 0 is the worst quality and totally unsatisfied, 10 is the best quality and fully satisfied
at 24 hours after surgery
score of visual analogue scale (VAS) of anxiety
Time Frame: at 24 hours after the end of the surgery
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 24 hours after the end of the surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhihong LU

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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