NCT07445399

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Mar 2026Sep 2026

First Submitted

Initial submission to the registry

February 20, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

March 30, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 20, 2026

Last Update Submit

February 25, 2026

Conditions

Keywords

drawingcolorshapeanxietyheart rate variability

Outcome Measures

Primary Outcomes (1)

  • score of visual analogue scale (VAS) of anxiety

    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 Outcomes (5)

  • heart rate variability

    at the end of intervention, approximately 10 minutes before start of anesthesia

  • score of State-Trait Anxiety Inventory-State (STAI-S)

    at the end of intervention, approximately 10 minutes before start of anesthesia

  • Engagement level during the painting task

    from start of painting to end of painting , approximately 10 minutes

  • tachycardia

    from admitted into the operating room to start of anesthesia, at an average of 15 minutes

  • hypertension

    from admitted into the operating room to start of anesthesia, at an average of 15 minutes

Other Outcomes (1)

  • Individual preferences for colors and shapes

    before intervention, approximately 30 minutes before anesthesia

Study Arms (5)

A

EXPERIMENTAL

warm color and sharp shape are shown to the patients

Behavioral: warm colorBehavioral: sharp shape

B

EXPERIMENTAL

warm color and smooth shape are shown to the patients

Behavioral: warm colorBehavioral: smooth shape

C

EXPERIMENTAL

cold color and sharp shape are shown to the patients

Behavioral: cold colorBehavioral: sharp shape

D

EXPERIMENTAL

cold color and smooth shape are shown to the patients

Behavioral: cold colorBehavioral: smooth shape

E

NO INTERVENTION

Interventions

warm colorBEHAVIORAL

red and yellow color picture is used

AB
cold colorBEHAVIORAL

blue and green color is used

CD
sharp shapeBEHAVIORAL

triangle shaped picture is used

AC
smooth shapeBEHAVIORAL

circle and curve are used

BD

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 41095825BACKGROUND
  • 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.

    PMID: 40249469BACKGROUND
  • 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.

    PMID: 34491443BACKGROUND
  • 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.

    PMID: 33927077BACKGROUND
  • 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.

    PMID: 31799291BACKGROUND
  • 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.

    PMID: 26583656BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 20, 2026

First Posted

March 3, 2026

Study Start

March 30, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

March 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL
Time Frame
after publication
Access Criteria
with reasonable request to Dr. Zhihong Lu