The Effect of Mandala Activity on Life Satisfaction

The Effect of Mandala Activity on Life Satisfaction of Women Receiving Chemotherapy for Gynecological Cancer: A Randomized Controlled Study

This study aimed to determine the effect of mandala activity on life satisfaction of women receiving chemotherapy for gynecological cancer.

Study Overview

• Status: Completed
• Conditions: Gynecologic Cancer; ART; Life Satisfaction
• Intervention / Treatment: Behavioral: mandala

Detailed Description

Data will be collected using the descriptive information form and the Life Satisfaction Scale.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Merkez
    • Tunceli, Merkez, Turkey, 62002
      • Munzur University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Receiving chemotherapy
• No communication problems
• Having at least 6 months of cancer diagnosis
• Being in Stage 2 and Stage 3 of the disease

Exclusion Criteria:

• Having a medical device (IV catheter, etc.) or physical symptoms (vision problems, Parkinson's disease, etc.) that may prevent mandala drawing.
• Being in Stage 1 and Stage 4 of the disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: mandala; As in the case of previous studies, to prevent confusion and make the mandala drawing process easier, a few videos describing what a mandala is were shown to the patients, and information was provided. Next, each patient was given a set of felt-tip pens (in 24 different colors) and ready-to-use mandala papers, and they were asked to complete the mandala activity. The patients were given empty mandala books with enough pages for them to draw mandalas every day, they were asked to perform the mandala activity regularly in a time interval of their own choice every day, and whether they performed the activity was checked daily without them noticing (so that they would not have the feeling of being checked on or inspected).	Behavioral: mandala; The Life Satisfaction Scale was administered to patients in the control group at the first encounter (pre-test) and three weeks after the first encounter (post-test). Although the pre- and post-test treatment protocols were the same for both intervention and control groups, the only difference between their treament was the mandala activity, which was not applied to those in the control group. Patients in the control group continued their routine lives at home for three weeks. After the application, the mandala activity was applied to all patients who wanted it.; Other Names: control group
NO_INTERVENTION: control group; The Life Satisfaction Scale was administered to patients in the control group at the first encounter (pre-test) and three weeks after the first encounter (post-test). Although the pre- and post-test treatment protocols were the same for both intervention and control groups, the only difference between their treament was the mandala activity, which was not applied to those in the control group. Patients in the control group continued their routine lives at home for three weeks. After the application, the mandala activity was applied to all patients who wanted it.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Life satisfaction scale mean	Average score from life satisfaction scale ( Minimum score; 5, Maximum score;25)	up to 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Life satisfaction scale mean	Average score from life satisfaction scale( Minimum score;5 , Maximum score;25)	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Munzur University
• Investigators: Principal Investigator: Nursel A Dal, Assist Prof, Munzur Ünivesitesi

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2021
• Primary Completion (ACTUAL): November 1, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (ACTUAL): March 17, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Gynecologic Cancer; Mandala; Life satisfaction
• Other Study ID Numbers: munzur u

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No