- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07445399
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
Status
Not yet recruiting
Conditions
Intervention / Treatment
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
- Name: Zhihong Lu
- Phone Number: 86-13891975018
- Email: deerlu23@163.com
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
- Vetter D, Barth J, Uyulmaz S, Uyulmaz S, Vonlanthen R, Belli G, Montorsi M, Bismuth H, Witt CM, Clavien PA. Effects of Art on Surgical Patients: A Systematic Review and Meta-analysis. Ann Surg. 2015 Nov;262(5):704-13. doi: 10.1097/SLA.0000000000001480.
- Eminovic S, Vincze G, Fink A, Fischerauer SF, Sadoghi P, Leithner A, Kamolz LP, Tscheliessnigg K, Bernhardt GA. Positive effect of colors and art in patient rooms on patient recovery after total hip or knee arthroplasty : A randomized controlled trial. Wien Klin Wochenschr. 2022 Mar;134(5-6):221-226. doi: 10.1007/s00508-021-01936-6. Epub 2021 Sep 7.
- Takemura Y, Kido K, Morozumi T, Sanuki T, Yao T, Mukai Y. Effects of Different Visual Color Stimuli on Stress Responses in Patients with Dental Phobia. J Clin Med. 2025 Sep 24;14(19):6745. doi: 10.3390/jcm14196745.
- Liu Y, Chen XF. Impact of labiaplasty on psychological well-being and quality of life in Chinese women: Findings from a single-center retrospective study. Int J Gynaecol Obstet. 2025 Oct;171(1):423-430. doi: 10.1002/ijgo.70171. Epub 2025 Apr 18.
- Zhou S, Wei L, Wang Z, Zhou Z, Hu S, Yan X, Hua W, Chen J. Effect of painting intervention based on Mandala-self theory on mood and physiological state in patients in preoperative waiting room. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2021 Mar 28;46(3):293-299. doi: 10.11817/j.issn.1672-7347.2021.190795. Chinese, English.
- Luis M, Doss R, Zayed B, Yacoub M. Effect of live oud music on physiological and psychological parameters in patients undergoing cardiac surgery. Glob Cardiol Sci Pract. 2019 Sep 20;2019(2):e201917. doi: 10.21542/gcsp.2019.17.
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
Keywords
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.