Cancer PainNCT06590389
The Effect Of Mandala Activity On Postoperative Pain And Anxiety Levels In Gynecological Oncology Patients
A study testing mandala activity in people with Cancer Pain and Cancer, Treatment-Related, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study was designed as a randomised controlled, 2-group, pre-test post-test comparative, experimental study to examine the effect of mandala activity on postoperative pain, anxiety levels and analgesia use of gynaecological oncology patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer Pain, Cancer, Treatment-Related, Cancer
- What is being tested?
- mandala activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 1 Aug 2023
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a gynecological oncology disease diagnosis,
- Having had open abdominal hysterectomy surgery,
- Being over 18 years of age,
- Ability to communicate in Turkish,
- Having a gynecological oncology operation for the first time,
- There is no physical disability related to the upper extremities.
Who cannot join
- Readmission due to any complications that develop after discharge,
- Having visual, hearing and speech disabilities
Trial locations and contacts
1 site in 1 country.
About this study
This study was designed as a randomised controlled, 2-group, pre-test post-test comparative, experimental study to examine the effect of mandala activity on postoperative pain, anxiety levels and analgesia use of gynaecological oncology patients.
Read the detailed description
This study was designed as a randomised controlled, 2-group, pre-test post-test comparative, experimental study to examine the effect of mandala activity on postoperative pain, anxiety levels and analgesia use of gynaecological oncology patients.
The study was conducted with 42 patients who underwent open abdominal hysterectomy surgery in the Gynecological Oncology Surgery Clinic of a training and research hospital in Istanbul between 1 February 2023 and 1 August 2023. Patients in the intervention group (n=21) received mandala activity at least once a day during their postoperative hospitalisation (days 0-2). Patients in the control group (n=21) did not receive any intervention. Introductory Information Form, Visual Analogue Scale (VAS), State-Trait Anxiety Inventory (STAI-I), Postoperative Patient Evaluation Form and Mandala Activity Booklet were used in the study.
- Conditions
- Cancer Pain, Cancer, Treatment-Related, Cancer
- Being tested
- mandala activity
- Keywords
- pain, anxiety, midwife, Gynecological Oncology, mandala
- Medical subject headings
- Cancer Pain, Neoplasms, Second Primary, Neoplasms, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mandala activityOther
A descriptive patient form, VAS and STAI-I were applied before surgery. After the surgery, VAS and STAI-I were applied before and after the mandala activity until the patient was discharged. The VAS form was applied every 4 hours until the patient was discharged. This process was repeated in the same way for the entire intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (Mandala activity) | Experimental | Mandala activity is painting with different pictures or shapes by creating a harmony of figures in different or the same colors. The entire intervention group was given a booklet consisting of 10 simple mandala drawings prepared by the researchers. Mandala activity: During the hospital stay on the zeroth, first and second postoperative days, the patient was asked to color the mandala drawing of his choice from the booklet as many times as he wanted. However, they were asked to practice at least one mandala activity every day. For painting in the mandala activity, a set of 12 colored crayons was given to the patients by the researcher and no color guidance was given for painting. The research was continued by following up within 3 days, namely the zeroth, first and second postoperative days. VAS and STAI-I forms were applied before and after the mandala activity. Receives: Other: mandala activity |
| Control group | No intervention | After the patient was mobilized on the zero postoperative day, STAI-I and VAS were applied 1 hour apart. VAS was repeated every 4 hours until the patient was discharged. * On the first day after surgery, VAS with STAI-I was applied to the patient every 1 hour after breakfast, and VAS was repeated every 4 hours during the day. * On the second day after the surgery, STAI-I and VAS were applied to the patient 1 hour apart after breakfast. * On the second postoperative day, the Postoperative Period Patient Evaluation form was applied to the patient before discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
This scale is used to visually assess and then quantify values that cannot be measured quantitatively. It was used to measure the pain intensity of gynecologic oncology patients in both the intervention and control groups. In this scale, the variable to be evaluated is written on both ends of a 100 mm long line. The patient was asked to place a line, dot or cross on this beam by asking which one she was closer to. For example, the leftmost part is labeled "no pain" and the other end is labeled "most severe pain". The patient makes a mark on the ray according to his/her current condition. Starting from the left end, i.e. where there is no pain at all, the part up to the point where the patient has pain, i.e. where the patient makes a mark, is measured. This quantity indicates the intensity of the patient's pain. The increase in quality and quantity indicates an increase in pain intensity.
Measured: 1 February 2023 - 1 August 2023 (6 months or 182 days)
Secondary outcomes (1)
Number of analgesia use
It is a form used to evaluate the use of postoperative analgesia in gynaecological oncology patients.
Measured: 1 February 2023 - 1 August 2023 (6 months or 182 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Feb 2023
- Primary completion1 Feb 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Model description
- The research was designed as a randomized controlled, 2-group (intervention and control) pre-test post-test comparative experimental research.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Demir Yıldırım, PhD, Istanbul University - Cerrahpasa
- Investigators
- Ayça Demir Yıldırım, Phd, Study director, https://uskudar.edu.tr/akademik-personel/ayca-demir-yildirim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590389
- Sponsor's protocol ID
- SAkyol-001
- Status last verified
- Sep 2024
- First submitted
- 7 Jul 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A research paper was planned to make individual participant data (IPD) available to other researchers.
Publications
T.C. Ministry of Health Public Health Institution of Turkey 2013-2018 National Cancer Control Plan, Ed: Keskinkılıç B. [Internet]. 2022 [Accessed on 3.10.2022]. Access address: https://hsgm.saglik.gov.tr/depo/birimler/kanser-db/yayinlar/raporlar
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338TÜİK. Cause of Death Statistics, 2017. tuikweb.tuik.gov.tr/PreHaberBultenleri.do?id=27592 https://hsgm.saglik.gov.tr/depo/birimler/kanser-db/istatistik/Turkiye_Kanser_Istatistikleri_2017.pdf Date of access: 1.10.2022
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Hawkins Y, Ussher J, Gilbert E, Perz J, Sandoval M, Sundquist K. Changes in sexuality and intimacy after the diagnosis and treatment of cancer: the experience of partners in a sexual relationship with a person with cancer. Cancer Nurs. 2009 Jul-Aug;32(4):271-80. doi: 10.1097/NCC.0b013e31819b5a93.
PubMed 19444088Afiyanti Y, Milanti A, Putri RH. Supportive care needs in predicting the quality of life among gynecological cancer patients. Can Oncol Nurs J. 2018 Feb 1;28(1):22-29. doi: 10.5737/236880762812229. eCollection 2018 Winter.
PubMed 31148629Jiang XH, Chen XJ, Xie QQ, Feng YS, Chen S, Peng JS. Effects of art therapy in cancer care: A systematic review and meta-analysis. Eur J Cancer Care (Engl). 2020 Sep;29(5):e13277. doi: 10.1111/ecc.13277. Epub 2020 Jun 15.
PubMed 32542749Spielberger, C. D. (1983). State-trait anxiety inventory for adults. Mind Garden.https://www.tandfonline.com/doi/pdf/10.1080/07481756.1985.12022795
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Mandala Activity On Postoperative Pain And Anxiety Levels In Gynecological Oncology Patients
- ClinicalTrials.gov ID
- NCT06590389
- Acronym / sponsor ID
- SAkyol-001
- Conditions
- Cancer Pain, Cancer, Treatment-Related, Cancer
- Keywords
- pain, anxiety, midwife, Gynecological Oncology, mandala
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 19 Sep 2024 (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.
This study was designed as a randomised controlled, 2-group, pre-test post-test comparative, experimental study to examine the effect of mandala activity on postoperative pain, anxiety levels and analgesia use of gynaecological oncology patients.
Detailed description
This study was designed as a randomised controlled, 2-group, pre-test post-test comparative, experimental study to examine the effect of mandala activity on postoperative pain, anxiety levels and analgesia use of gynaecological oncology patients.
The study was conducted with 42 patients who underwent open abdominal hysterectomy surgery in the Gynecological Oncology Surgery Clinic of a training and research hospital in Istanbul between 1 February 2023 and 1 August 2023. Patients in the intervention group (n=21) received mandala activity at least once a day during their postoperative hospitalisation (days 0-2). Patients in the control group (n=21) did not receive any intervention. Introductory Information Form, Visual Analogue Scale (VAS), State-Trait Anxiety Inventory (STAI-I), Postoperative Patient Evaluation Form and Mandala Activity Booklet were used in the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The research was designed as a randomized controlled, 2-group (intervention and control) pre-test post-test comparative experimental research.
| Arm | Type | Receives |
|---|---|---|
| Intervention group (Mandala activity) | Experimental | Other: mandala activityMandala activity is painting with different pictures or shapes by creating a harmony of figures in different or the same colors. The entire intervention group was given a booklet consisting of 10 simple mandala drawings prepared by the researchers. Mandala activity: During the hospital stay on the zeroth, first and second postoperative days, the patient was asked to color the mandala drawing of his choice from the booklet as many times as he wanted. However, they were asked to practice at least one mandala activity every day. For painting in the mandala activity, a set of 12 colored crayons was given to the patients by the researcher and no color guidance was given for painting. The research was continued by following up within 3 days, namely the zeroth, first and second postoperative days. VAS and STAI-I forms were applied before and after the mandala activity. |
| Control group | No intervention | –After the patient was mobilized on the zero postoperative day, STAI-I and VAS were applied 1 hour apart. VAS was repeated every 4 hours until the patient was discharged. * On the first day after surgery, VAS with STAI-I was applied to the patient every 1 hour after breakfast, and VAS was repeated every 4 hours during the day. * On the second day after the surgery, STAI-I and VAS were applied to the patient 1 hour apart after breakfast. * On the second postoperative day, the Postoperative Period Patient Evaluation form was applied to the patient before discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Having a gynecological oncology disease diagnosis,
- Having had open abdominal hysterectomy surgery,
- Being over 18 years of age,
- Ability to communicate in Turkish,
- Having a gynecological oncology operation for the first time,
Key exclusion criteria (2 listed)
- Readmission due to any complications that develop after discharge,
- Having visual, hearing and speech disabilities
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 |
|---|---|---|
| mandala activityA descriptive patient form, VAS and STAI-I were applied before surgery. After the surgery, VAS and STAI-I were applied before and after the mandala activity until the patient was discharged. The VAS form was applied every 4 hours until the patient was discharged. This process was repeated in the same way for the entire intervention group. | Other | Intervention group (Mandala activity) |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 1 February 2023 - 1 August 2023 (6 months or 182 days)
This scale is used to visually assess and then quantify values that cannot be measured quantitatively. It was used to measure the pain intensity of gynecologic oncology patients in both the intervention and control groups. In this scale, the variable to be evaluated is written on both ends of a 100 mm long line. The patient was asked to place a line, dot or cross on this beam by asking which one she was closer to. For example, the leftmost part is labeled "no pain" and the other end is labeled "most severe pain". The patient makes a mark on the ray according to his/her current condition. Starting from the left end, i.e. where there is no pain at all, the part up to the point where the patient has pain, i.e. where the patient makes a mark, is measured. This quantity indicates the intensity of the patient's pain. The increase in quality and quantity indicates an increase in pain intensity.
1 secondary outcome
Number of analgesia use
Time frame: 1 February 2023 - 1 August 2023 (6 months or 182 days)
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 1 Oct 2024.
- BackgroundT.C. Ministry of Health Public Health Institution of Turkey 2013-2018 National Cancer Control Plan, Ed: Keskinkılıç B. [Internet]. 2022 [Accessed on 3.10.2022]. Access address: https://hsgm.saglik.gov.tr/depo/birimler/kanser-db/yayinlar/raporlar
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- BackgroundTÜİK. Cause of Death Statistics, 2017. tuikweb.tuik.gov.tr/PreHaberBultenleri.do?id=27592 https://hsgm.saglik.gov.tr/depo/birimler/kanser-db/istatistik/Turkiye_Kanser_Istatistikleri_2017.pdf Date of access: 1.10.2022
- Background: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Background: PubMed 19444088Hawkins Y, Ussher J, Gilbert E, Perz J, Sandoval M, Sundquist K. Changes in sexuality and intimacy after the diagnosis and treatment of cancer: the experience of partners in a sexual relationship with a person with cancer. Cancer Nurs. 2009 Jul-Aug;32(4):271-80. doi: 10.1097/NCC.0b013e31819b5a93.
- Background: PubMed 31148629Afiyanti Y, Milanti A, Putri RH. Supportive care needs in predicting the quality of life among gynecological cancer patients. Can Oncol Nurs J. 2018 Feb 1;28(1):22-29. doi: 10.5737/236880762812229. eCollection 2018 Winter.
- Background: PubMed 32542749Jiang XH, Chen XJ, Xie QQ, Feng YS, Chen S, Peng JS. Effects of art therapy in cancer care: A systematic review and meta-analysis. Eur J Cancer Care (Engl). 2020 Sep;29(5):e13277. doi: 10.1111/ecc.13277. Epub 2020 Jun 15.
- BackgroundSpielberger, C. D. (1983). State-trait anxiety inventory for adults. Mind Garden.https://www.tandfonline.com/doi/pdf/10.1080/07481756.1985.12022795
- Individual participant dataSharing planned: No. A research paper was planned to make individual participant data (IPD) available to other researchers.
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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.
Ayça Demir Yıldırım, Phd study director
https://uskudar.edu.tr/akademik-personel/ayca-demir-yildirim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mandala activity in people with Cancer Pain and Cancer, Treatment-Related, run by Istanbul University - Cerrahpasa 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 2 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 1 Oct 2024. 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?
Visual Analogue Scale (VAS) (time frame: 1 February 2023 - 1 August 2023 (6 months or 182 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06590389, which also lists 8 linked publications.
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 1 Oct 2024.