The Effect of Artistic Activities on Anxiety, Spiritual Well-Being, Hope, and Vital Signs in Patients Undergoing Abdominal Surgery: A Randomized Controlled Trial
1 other identifier
interventional
64
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2025
Shorter than P25 for not_applicable
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2025
CompletedFirst Submitted
Initial submission to the registry
November 20, 2025
CompletedFirst Posted
Study publicly available on registry
December 16, 2025
CompletedDecember 16, 2025
July 1, 2025
3 months
November 20, 2025
December 2, 2025
Conditions
Keywords
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
EXPERIMENTALmandala group
Control group
ACTIVE COMPARATORdeep breathing exercises
Interventions
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.
Eligibility Criteria
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)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
NAzife Gamze Özer Özlü, Phd
Dokuz Eylul university Nursing Faculty
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