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

September 27, 2024 updated by: Ayça Demir Yıldırım, PhD, Istanbul University - Cerrahpasa (IUC)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Üsküdar
      • Istanbul, Üsküdar, Turkey, 34674
        • Uskudar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 February 2023 - 1 August 2023 (6 months or 182 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of analgesia use
Time Frame: 1 February 2023 - 1 August 2023 (6 months or 182 days)
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
State-Trait Anxiety Inventory I (STAI-I)
Time Frame: 1 February 2023 - 1 August 2023 (6 months or 182 days)
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.
1 February 2023 - 1 August 2023 (6 months or 182 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Study Director: Ayça Demir Yıldırım, Phd, https://uskudar.edu.tr/akademik-personel/ayca-demir-yildirim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

July 7, 2024

First Submitted That Met QC Criteria

September 6, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 27, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAkyol-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

A research paper was planned to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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