The Effect Of Mandala Activity On Postoperative Pain And Anxiety Levels In Gynecological Oncology Patients
NCT ID: NCT06590389
Last Updated: 2024-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
42 participants
INTERVENTIONAL
2023-02-01
2023-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Mandala Activity on Life Satisfaction
NCT05283460
Mandala Painting on Perioperative Psychological Well-Being,Emotional Self-Efficacy,Anxiety
NCT07160062
The Effect of Mandala Art Therapy on Anxiety and Pain
NCT06628557
Effects of Mandala Coloring on Anxiety and Quality of Life of Women in the Climacteric Period
NCT05575349
Yoga in Women With Surgical Menopause After Gynecological Cancer
NCT07141953
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention group (Mandala activity)
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.
mandala activity
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.
Control group
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
mandala activity
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* Having visual, hearing and speech disabilities
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Istanbul University - Cerrahpasa
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ayça Demir Yıldırım, PhD
Assistant Professor, PhD, Lecturer
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ayça Demir Yıldırım, Phd
Role: STUDY_DIRECTOR
https://uskudar.edu.tr/akademik-personel/ayca-demir-yildirim
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Üsküdar University
Istanbul, Üsküdar, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
TÜİK. 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.
Hawkins 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.
Afiyanti 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.
Jiang 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.
Spielberger, C. D. (1983). State-trait anxiety inventory for adults. Mind Garden.https://www.tandfonline.com/doi/pdf/10.1080/07481756.1985.12022795
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SAkyol-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.