The Effect Of Mandala Activity On Postoperative Pain And Anxiety Levels In Gynecological Oncology Patients

NCT06590389 | Completed

• 1 other identifier: SAkyol-001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer Pain; Cancer, Treatment-Related; Cancer

Keywords

pain; anxiety; midwife; Gynecological Oncology; mandala

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Number of analgesia use

  1 February 2023 - 1 August 2023 (6 months or 182 days)

Other Outcomes (1)

• State-Trait Anxiety Inventory I (STAI-I)

  1 February 2023 - 1 August 2023 (6 months or 182 days)

Study Arms (2)

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.

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.

Interventions

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.

Intervention group (Mandala activity)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women with gynecological oncology disease
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Readmission due to any complications that develop after discharge,
• Having visual, hearing and speech disabilities

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Üsküdar University

Istanbul, Üsküdar, 34674, Turkey (Türkiye)

Location

Related Publications (8)

• 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

  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.

  PMID: 33538338 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

  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.

  PMID: 30207593 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.

  PMID: 19444088 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.

  PMID: 31148629 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.

  PMID: 32542749 BACKGROUND

• Spielberger, C. D. (1983). State-trait anxiety inventory for adults. Mind Garden.https://www.tandfonline.com/doi/pdf/10.1080/07481756.1985.12022795

  BACKGROUND

MeSH Terms

Conditions

Cancer Pain; Neoplasms, Second Primary; Neoplasms; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Ayça Demir Yıldırım, Phd

  https://uskudar.edu.tr/akademik-personel/ayca-demir-yildirim

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PhD, Lecturer

Model Details: The research was designed as a randomized controlled, 2-group (intervention and control) pre-test post-test comparative experimental research.

Study Record Dates

• First Submitted: July 7, 2024
• First Posted: September 19, 2024
• Study Start: February 1, 2023
• Primary Completion: February 1, 2023
• Study Completion: August 1, 2023
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)