NCT07286097

Brief Summary

The surgical process can cause high levels of anxiety and stress in patients, and abdominal surgery is particularly anxiety-provoking due to the risk of severe pain and complications. Artistic activities can be an effective complementary method for reducing anxiety and improving mental well-being and hope levels in individuals. Studies have shown that activities such as music therapy and visual arts have positive effects on pain, anxiety, and vital signs in surgical patients. This randomized controlled trial aims to evaluate the effects of artistic activities on anxiety, spiritual well-being, hope, and vital signs in patients undergoing abdominal surgery. The research will be conducted on patients undergoing abdominal surgery at the Department of General Surgery at Dokuz Eylül University. The data collection tools used will be the "Patient Assessment Form," "Vital Signs Form," "Visual Analog Anxiety Scale," "Spiritual Well-Being Scale," and "State Hope Scale." The intervention group will participate in mandala coloring as an artistic activity, while the control group will perform breathing exercises. Data analysis will be conducted using the SPSS 29.0 software package. Descriptive and analytical statistics will be used in the data analysis. The results of the study will determine the effect of artistic activities performed on abdominal surgery patients in the preoperative period on anxiety, spiritual well-being, hope, and vital signs. Based on the effectiveness of preoperative artistic activities in clinical use, a decision will be made as to whether they are useful in preparing patients for surgery in the preoperative period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2025

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 16, 2025

Completed
Last Updated

December 16, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

November 20, 2025

Last Update Submit

December 2, 2025

Conditions

Keywords

Abdominal SurgerySpiritual Well-beingArt Therapy

Outcome Measures

Primary Outcomes (3)

  • anxiety

    Anxiety levels will be measured using the Visual Analog Anxiety Scale (VAAS). The scale ranges from 0 to 10, where 0 indicates no anxiety and 10 indicates the highest possible anxiety. Higher scores represent worse anxiety. The baseline (pre-test) measurement will be obtained during a face-to-face interview prior to the intervention.

    Baseline (pre-test), before the intervention - assessed once immediately prior to the intervention.

  • Spiritual Well-Being

    Spiritual well-being will be assessed using the Spiritual Well-Being Scale.It was developed by Daaleman and Frey (2004), and its Turkish validity and reliability study was conducted by Serbest and Şahin (2022). The scale consists of 12 items and two subscales (self-efficacy and life plan). Participants' responses are rated on a 5-point Likert-type response scale ranging from 1 = "Strongly agree" to 5 = "Strongly disagree." The total score of the scale ranges from 12 to 60. The baseline (pre-test) measurement will be obtained during a face-to-face interview prior to the intervention.

    Baseline (pre-test), before the intervention - assessed once immediately prior to the intervention.

  • State Hope

    Hope levels will be assessed using the State Hope Scale. The scale consists of six items. Responses were collected using an 8-point Likert scale (1= Strongly disagree, 4= Somewhat disagree, 8= Strongly agree).

    Baseline (pre-test), before the intervention - assessed once immediately prior to the intervention.

Secondary Outcomes (1)

  • Vital signs

    Baseline (pre-test), before the intervention-assessed once immediately prior to the intervention.

Study Arms (2)

Art group

EXPERIMENTAL

mandala group

Behavioral: Art activities

Control group

ACTIVE COMPARATOR

deep breathing exercises

Behavioral: breathing exercises

Interventions

Art activitiesBEHAVIORAL

In the study, pre-tests and post-tests were administered to patients in the experimental and control groups by the first researcher in the patients' rooms. The pre-test data for the study will be collected using the "Patient Diagnosis Form," "Vital Signs Form," "Visual Analog Anxiety Scale," "Spiritual Well-Being Scale," and "State Hope Scale" through face-to-face interviews lasting an average of 10 minutes. After the data is collected, the experimental group will participate in art activities from the body and mind therapy group, while the control group will perform breathing exercises. Final test data will be collected 10 minutes after the activities are completed.

Art group

the control group will perform breathing exercises

Control group

Eligibility Criteria

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

You may qualify if:

  • Be 18 years of age or older
  • Be scheduled to undergo elective abdominal surgery (stomach, esophagus, colorectal, hepatobiliary)
  • Be conscious and able to communicate
  • Be willing to participate in the study

You may not qualify if:

  • Patients requiring emergency abdominal surgery
  • Patients with chronic psychiatric disorders
  • Patients with severe cognitive impairment
  • Patients with severe hearing or vision loss
  • Patients requiring intensive care
  • Patients with degenerative brain disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • NAzife Gamze Özer Özlü, Phd

    Dokuz Eylul university Nursing Faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 16, 2025

Study Start

May 7, 2025

Primary Completion

August 7, 2025

Study Completion

August 15, 2025

Last Updated

December 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations