Drawing Therapy for pReoperative Anxiety in Waiting (DRAW)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhihong LU

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients scheduled for elective surgery

age ≥18 yrs old

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • warm color

    Behavioral

    red and yellow color picture is used

  • cold color

    Behavioral

    blue and green color is used

  • sharp shape

    Behavioral

    triangle shaped picture is used

  • smooth shape

    Behavioral

    circle and curve are used

Treatment groups

272 Participants
are divided into 4 treatment groups
Group A: AExperimental treatment 2 interventions
Group B: BExperimental treatment 2 interventions
Group C: CExperimental treatment 2 interventions
Group D: DExperimental treatment 2 interventions

Trial outcomes

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.

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

Secondary outcomes

1

heart rate

Time frame
at the end of intervention, approximately 10 minutes before start of anesthesia
2

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

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.

Time frame
at the end of intervention, approximately 10 minutes before start of anesthesia
3

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.

Time frame
Before anesthesia induction, approximately 1 minute before start of anesthesia
4

Engagement level during the painting task

measured by a 0-10 subjective rating scale, 0 is not engaged, 10 is totally engaged

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

Other outcomes

1

Individual preferences for colors and shapes

1, prefer curve and warm color; 2, prefer angle and warm color; 3, prefer curve and cold color; 4, prefer angle and cold color

Time frame
before intervention, approximately 30 minutes before anesthesia

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhihong LU

Lead sponsor

Air Force Military Medical University, China

Sponsor institution

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