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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mandala activity | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 February 2023 - 1 August 2023 (6 months or 182 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of analgesia use | It is a form used to evaluate the use of postoperative analgesia in gynaecological oncology patients. | 1 February 2023 - 1 August 2023 (6 months or 182 days) |
| Measure | Description | Time Frame |
|---|---|---|
| State-Trait Anxiety Inventory I (STAI-I) | The scale measures state and trait anxiety as Likert scale with 20 separate questions. The higher the scores, the higher the level of anxiety and the lower the scores, the lower the level of anxiety. The total score of both scales ranges from a minimum of 20 to a maximum of 80. A high score indicates a high level of anxiety and a low score indicates a low level of anxiety. |
Inclusion Criteria:
Exclusion Criteria:
Women with gynecological oncology disease
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| Name | Affiliation | Role |
|---|---|---|
| Ayça Demir Yıldırım, Phd | https://uskudar.edu.tr/akademik-personel/ayca-demir-yildirim | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Üsküdar University | Istanbul | Üsküdar | 34674 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 33538338 | Background | 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. | |
| Background | 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 | ||
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A research paper was planned to make individual participant data (IPD) available to other researchers.
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| ID | Term |
|---|---|
| D000072716 | Cancer Pain |
| D016609 | Neoplasms, Second Primary |
| D009369 | Neoplasms |
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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The research was designed as a randomized controlled, 2-group (intervention and control) pre-test post-test comparative experimental research.
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Randomizer.org website was used for randomization of the research sample. It consists of four rooms, patient room numbers 634, 635, 636 and 637. The room numbers obtained during randomization were assigned to the 1st group intervention (21 cases of open abdominal surgery) and the 2nd group to the control group (21 cases of open abdominal surgery) by simple random method. By entering the room numbers into two unique sets, patients sleeping in the rooms in the 1st set (634-636) and meeting the inclusion criteria were included in the intervention group. Patients sleeping in the rooms in the 2nd set (635-637) and meeting the inclusion criteria were included in the control group. was included in the group. In the study, each patient was included in the research group after informed consent was obtained. In case of refusal, consent was obtained from the next patient in the room and the process of obtaining consent was continued until the number of samples was completed.
|
| 1 February 2023 - 1 August 2023 (6 months or 182 days) |
| Background |
| 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. |
| 19444088 | Background | 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. |
| 31148629 | Background | 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. |
| 32542749 | Background | 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. |
| Background | Spielberger, C. D. (1983). State-trait anxiety inventory for adults. Mind Garden.https://www.tandfonline.com/doi/pdf/10.1080/07481756.1985.12022795 |