Colon CancerNCT07137000
The Effect of Art Therapy in Patients Undergoing Colorectal Cancer
A study testing Art therapy in people with Colon Cancer and Rectum Cancer, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
With the development of modern techniques, art has become important in the provision of health services and has enabled individuals to better recognise themselves and their surroundings. The World Health Organisation states that art has an important role in improving health, preventing and treating diseases. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colon Cancer, Rectum Cancer
- What is being tested?
- Art therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18 and 70,
- Planned colorectal cancer surgery,
- Not receiving neoadjuvant treatment (chemotherapy, radiotherapy),
- No diagnosed psychiatric disorder,
- No history of anxiolytic drug use,
- Patients who volunteered to participate in the study
Who cannot join
- Communication difficulties,
- Mental deficiency,
- Patients with dysfunction or disease in their upper extremities that may prevent them from performing art therapy practices
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Pendik Training and Research Hospital
Istanbul, 34876
About this study
Official title: The Effect of Art Therapy on Pain, Anxiety, Hope and Life Satisfaction in Patients Undergoing Colorectal Cancer Surgery: A Randomized Controlled Trial
With the development of modern techniques, art has become important in the provision of health services and has enabled individuals to better recognise themselves and their surroundings. The World Health Organisation states that art has an important role in improving health, preventing and treating diseases. Art therapy is a therapy method that includes various art branches such as music, painting, sculpture and is especially applied to individuals with oncological diseases. The place of art therapy in solving the negative biopsychosocial problems experienced by these individuals before and after surgery is increasing day by day. Although there are studies on art therapy in the literature, there is no study on art therapy after colorectal cancer surgery. Therefore, in this study, it is aimed to examine the effect of art therapy applied to patients undergoing colorectal surgery on pain, anxiety, hope and life satisfaction. The population of the study will consist of patients who underwent colorectal cancer surgery in Marmara University Pendik Training and Research Hospital General Surgery Service between December 2024 and June 2025, and the sample will consist of 96 patients who meet the research criteria and accept to participate in the study. Patients participating in the study will be divided into two equal groups as intervention and control group. In the preoperative period, the patients in the intervention and control groups will be informed about the study, written and verbal consent will be obtained from the participants who accept the study, and the patients will be asked to answer the Patient Identification Form, Herth Hope Scale and Life Satisfaction Scale. The haemodynamic parameters of the patients in the intervention group will be recorded at 14:00 on the 1st, 2nd and 3rd postoperative days, the art therapy activity they have determined will be applied for 40 minutes and the data will be obtained using the Visual Analogue Scale, State Anxiety Inventory, Herth Hope Scale and Satisfaction with Life Scale. Patients in the control group will receive only routine ward care and data will be collected on the same days and hours as the intervention group. The data obtained will be analysed with appropriate statistical methods using SPSS Windows 22.0 software. As a result of the study, it is thought that there will be an improvement in the pain, anxiety, hope and life satisfaction of the participants.
- Conditions
- Colon Cancer, Rectum Cancer
- Being tested
- Art therapy
- Keywords
- surgical nursing, art therapy, pain, anxiety, hope, life satisfaction
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Pain, Anxiety Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art therapyOther
Five different art therapy methods (making bead jewelry, pencil drawing, painting, mandala, making clay figures) be used for people in this group.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No application will be made to this group, and an evaluation will be made after routine nursing care. |
| İntervention group (Art Teraphy) | Experimental | Five different art therapy methods (bead jewelry making, pencil drawing, painting, mandala, clay figure making) will be applied to the people in this group. Receives: Other: Art therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
First evaluation- Pain
It is a one-dimensional scale used to numerically express pain intensity. This scale consists of a 10-cm-long ruler with the words "no pain" at one end and "unbearable pain" at the other. A score of 0 cm on the scale indicates no pain, while a score of 10 cm indicates unbearable pain. As the score on the scale increases, the pain intensity increases.
Measured: Patients' pain will be assessed on postoperative days 1, 2, and 3, and on day 10 of discharge. This study is expected to last a total of 6 months, with data collection on the specified days.
Anxiety level
The anxiety level of the patients will be determined using the State Anxiety Inventory. The scale consists of a total of 20 items. Each item is rated on a four-point Likert-type scale: (1) not at all, (2) a little, (3) a lot, and (4) completely. The total score obtained ranges from 20 to 80. Higher scores indicate higher anxiety.
Measured: Patients' anxiety will be assessed on postoperative days 1, 2, and 3, and on day 10 of discharge. This study is expected to last a total of 6 months, with data collection on the specified days.
Hope Levels
Patients' hope levels will be assessed using the Herth Hope Scale. The scale consists of 30 items and three subscales. Each item has response options of "Not at all appropriate," "Rarely appropriate," "Sometimes appropriate," and "Always appropriate." The total score for the scale ranges from 0 to 90, with higher scores indicating higher hope.
Measured: It will be evaluated one day before surgery, on the 3rd day after surgery, and on the 10th day after discharge.
Life Satisfaction
Patients' life satisfaction will be assessed using the Life Satisfaction Scale. The scale, consisting of five items addressing life satisfaction, has a Cronbach's alpha of 0.88. The possible score range is 5-25. A low score indicates that the individual has low life satisfaction.
Measured: It will be evaluated one day before surgery, on the 3rd day after surgery, and on the 10th day after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Mar 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Bozkurt, Saglik Bilimleri Universitesi
- Investigators
- Elif Gezginci Akpinar, Assoc. Prof., PhD, Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137000
- Sponsor's protocol ID
- Saglik-1000-367
- Status last verified
- Aug 2025
- First submitted
- 10 Jul 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Art Therapy on Pain, Anxiety, Hope and Life Satisfaction in Patients Undergoing Colorectal Cancer Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07137000
- Acronym / sponsor ID
- Saglik-1000-367
- Conditions
- Colon Cancer, Rectum Cancer
- Keywords
- surgical nursing, art therapy, pain, anxiety, hope, life satisfaction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Aug 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.
With the development of modern techniques, art has become important in the provision of health services and has enabled individuals to better recognise themselves and their surroundings. The World Health Organisation states that art has an important role in improving health, preventing and treating diseases. Art therapy is a therapy method that includes various art branches such as music, painting, sculpture and is especially applied to individuals with oncological diseases. The place of art therapy in solving the negative biopsychosocial problems experienced by these individuals before and after surgery is increasing day by day. Although there are studies on art therapy in the literature, there is no study on art therapy after colorectal cancer surgery. Therefore, in this study, it is aimed to examine the effect of art therapy applied to patients undergoing colorectal surgery on pain, anxiety, hope and life satisfaction. The population of the study will consist of patients who underwent colorectal cancer surgery in Marmara University Pendik Training and Research Hospital General Surgery Service between December 2024 and June 2025, and the sample will consist of 96 patients who meet the research criteria and accept to participate in the study. Patients participating in the study will be divided into two equal groups as intervention and control group. In the preoperative period, the patients in the intervention and control groups will be informed about the study, written and verbal consent will be obtained from the participants who accept the study, and the patients will be asked to answer the Patient Identification Form, Herth Hope Scale and Life Satisfaction Scale. The haemodynamic parameters of the patients in the intervention group will be recorded at 14:00 on the 1st, 2nd and 3rd postoperative days, the art therapy activity they have determined will be applied for 40 minutes and the data will be obtained using the Visual Analogue Scale, State Anxiety Inventory, Herth Hope Scale and Satisfaction with Life Scale. Patients in the control group will receive only routine ward care and data will be collected on the same days and hours as the intervention group. The data obtained will be analysed with appropriate statistical methods using SPSS Windows 22.0 software. As a result of the study, it is thought that there will be an improvement in the pain, anxiety, hope and life satisfaction of the participants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No application will be made to this group, and an evaluation will be made after routine nursing care. |
| İntervention group (Art Teraphy) | Experimental | Other: Art therapyFive different art therapy methods (bead jewelry making, pencil drawing, painting, mandala, clay figure making) will be applied to the people in this group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Between the ages of 18 and 70,
- Planned colorectal cancer surgery,
- Not receiving neoadjuvant treatment (chemotherapy, radiotherapy),
- No diagnosed psychiatric disorder,
- No history of anxiolytic drug use,
Key exclusion criteria (3 listed)
- Communication difficulties,
- Mental deficiency,
- Patients with dysfunction or disease in their upper extremities that may prevent them from performing art therapy practices
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 therapyFive different art therapy methods (making bead jewelry, pencil drawing, painting, mandala, making clay figures) be used for people in this group. | Other | İntervention group (Art Teraphy) |
Primary outcome
First evaluation- Pain
Time frame: Patients' pain will be assessed on postoperative days 1, 2, and 3, and on day 10 of discharge. This study is expected to last a total of 6 months, with data collection on the specified days.
It is a one-dimensional scale used to numerically express pain intensity. This scale consists of a 10-cm-long ruler with the words "no pain" at one end and "unbearable pain" at the other. A score of 0 cm on the scale indicates no pain, while a score of 10 cm indicates unbearable pain. As the score on the scale increases, the pain intensity increases.
Anxiety level
Time frame: Patients' anxiety will be assessed on postoperative days 1, 2, and 3, and on day 10 of discharge. This study is expected to last a total of 6 months, with data collection on the specified days.
The anxiety level of the patients will be determined using the State Anxiety Inventory. The scale consists of a total of 20 items. Each item is rated on a four-point Likert-type scale: (1) not at all, (2) a little, (3) a lot, and (4) completely. The total score obtained ranges from 20 to 80. Higher scores indicate higher anxiety.
Hope Levels
Time frame: It will be evaluated one day before surgery, on the 3rd day after surgery, and on the 10th day after discharge.
Patients' hope levels will be assessed using the Herth Hope Scale. The scale consists of 30 items and three subscales. Each item has response options of "Not at all appropriate," "Rarely appropriate," "Sometimes appropriate," and "Always appropriate." The total score for the scale ranges from 0 to 90, with higher scores indicating higher hope.
Life Satisfaction
Time frame: It will be evaluated one day before surgery, on the 3rd day after surgery, and on the 10th day after discharge.
Patients' life satisfaction will be assessed using the Life Satisfaction Scale. The scale, consisting of five items addressing life satisfaction, has a Cronbach's alpha of 0.88. The possible score range is 5-25. A low score indicates that the individual has low life satisfaction.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Elif Gezginci Akpinar, Assoc. Prof., PhD study director
Saglik Bilimleri Universitesi
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 therapy in people with Colon Cancer and Rectum Cancer, run by Saglik Bilimleri Universitesi 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 6 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 22 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
First evaluation- Pain (time frame: Patients' pain will be assessed on postoperative days 1, 2, and 3, and on day 10 of discharge. This study is expected to last a total of 6 months, with data collection on the specified days.). The study lists 4 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 22 Aug 2025.