This Study Evaluates the Effect of Artistic Activities on Anxiety, Spiritual Well-being, Hope, and Vital Signs in Abdominal Surgery PatientsNCT07286097
The Effect of Artistic Activities on Anxiety, Spiritual Well-Being, Hope, and Vital Signs in Patients Undergoing Abdominal Surgery: A Randomized Controlled Trial
A study testing Art activities and breathing exercises in people with This Study Evaluates the Effect of Artistic Activities on Anxiety, Spiritual Well-being, Hope, and Vital Signs in Abdominal Surgery Patients, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- This Study Evaluates the Effect of Artistic Activities on Anxiety, Spiritual Well-being, Hope, and Vital Signs in Abdominal Surgery Patients
- What is being tested?
- Art activities and breathing exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 May 2025to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Art activities, breathing exercises
- Keywords
- Abdominal Surgery, Spiritual Well-being, Art Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art activitiesBehavioural
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.
breathing exercisesBehavioural
the control group will perform breathing exercises
| Study group | Role | What they receive |
|---|---|---|
| Art group | Experimental | mandala group Receives: Behavioral: Art activities |
| Control group | Active comparator | deep breathing exercises Receives: Behavioral: breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: Baseline (pre-test), before the intervention - assessed once immediately prior to the intervention.
Secondary outcomes (1)
Vital signs
Vital signs will be assessed using the Patient Vital Signs Form, which includes blood pressure, pulse, respiratory rate, temperature, and pain level. Measurements will be obtained following standard clinical procedures during the baseline (pre-test) assessment prior to the intervention. Values will be interpreted according to established physiological reference ranges, and higher pain scores represent worse symptoms.
Measured: Baseline (pre-test), before the intervention-assessed once immediately prior to the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start7 May 2025
- Primary completion7 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for This Study Evaluates the Effect of Artistic Activities on Anxiety, Spiritual Well-being, Hope, and Vital Signs in Abdominal Surgery PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Ayten Kankaya, Dokuz Eylul University
- Investigators
- Nazife Gamze Özer Özlü, Phd, Principal investigator, Dokuz Eylul university Nursing Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286097
- Sponsor's protocol ID
- 9711-GOA
- Status last verified
- Jul 2025
- First submitted
- 20 Nov 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Artistic Activities on Anxiety, Spiritual Well-Being, Hope, and Vital Signs in Patients Undergoing Abdominal Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07286097
- Acronym / sponsor ID
- 9711-GOA
- Keywords
- Abdominal Surgery, Spiritual Well-being, Art Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 7 May 2025 (actual)
- Primary completion
- 7 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Art group | Experimental | Behavioral: Art activitiesmandala group |
| Control group | Active comparator | Behavioral: breathing exercisesdeep breathing exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be 18 years of age or older
Key exclusion criteria (6 listed)
- Patients requiring emergency abdominal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Art activitiesIn 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. | Behavioural | Art group |
| breathing exercisesthe control group will perform breathing exercises | Behavioural | Control group |
Primary outcome
anxiety
Time frame: Baseline (pre-test), before the intervention - assessed once immediately prior to the intervention.
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.
Spiritual Well-Being
Time frame: Baseline (pre-test), before the intervention - assessed once immediately prior to the intervention.
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.
State Hope
Time frame: Baseline (pre-test), before the intervention - assessed once immediately prior to the intervention.
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).
1 secondary outcome
Vital signs
Time frame: Baseline (pre-test), before the intervention-assessed once immediately prior to the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazife Gamze Özer Özlü, Phd principal investigator
Dokuz Eylul university Nursing Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art activities and breathing exercises in people with This Study Evaluates the Effect of Artistic Activities on Anxiety, Spiritual Well-being, Hope, and Vital Signs in Abdominal Surgery Patients, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety (time frame: Baseline (pre-test), before the intervention - assessed once immediately prior to the intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.