The Effect of Mandala Application on Anxiety Level and Caregiver Burden in Palliative Care (MANDALAPLİC)

The Effect of Mandala Application on Anxiety Level and Caregiver Burden in Palliative Caregivers: A Randomized Controlled Trial

The caregivers of palliative care patients can also be negatively affected during the palliative care process. Especially family caregivers may experience difficulties in physical, social, economic, and psychological aspects. Non-pharmacological approaches are utilized to cope with these difficulties. The mandala study is one of the non-pharmacological approaches and has been utilized to support patients and caregivers in various illnesses. Mandala is a method that anyone can apply, based on coloring circular patterns. Recent studies have reported that mandala contributes to improving psychological and physiological well-being. This study is designed in a randomized controlled design to examine the effects of mandala application on anxiety levels and caregiver burden in palliative care caregivers. Caregivers who meet the inclusion and exclusion criteria will be randomly assigned to two groups using a computer program. Both groups of caregivers will be administered an information form, the STAI XT-1 State-Trait Anxiety Inventory, and the Zarit Burden Interview Scale. Then, the intervention group will be asked to apply mandala twice a week for 30 minutes for one month. After one month, the scales will be administered again. The caregivers in the control group will not receive any intervention, and after one month, the scales will be administered, and mandala application will be suggested. According to G Power analysis, with a Type I error (α) of 0.05 and a power (1-β) of 0.80, the minimum sample size that will meet the requirements is determined to be a total of 86 individuals (experimental: 43, control: 43). Considering potential sample loss, the aim is to reach 45 participants in each group. The statistical analysis of the data will be performed using SPSS version 22.0. Descriptive statistics such as frequency, median, standard deviation, mean, minimum, maximum, percentage, Kolmogorov-Smirnov test for normal distribution (N>30), skewness, and kurtosis will be used for sociodemographic characteristics. Correlation tests will be used for scale relationships, and ANOVA, Kruskal-Wallis, t-test, or Mann-Whitney U test and post-hoc tests will be used for scale comparisons according to independent variables. The significance level will be accepted as p<0.05.

Study Overview

• Status: Completed
• Conditions: Anxiety; Caregiver Burden; Palliative Care; Caregiver; Mandala
• Intervention / Treatment: Other: Mandala; Other: Routine care

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kağıthane
    • Istanbul, Kağıthane, Turkey, 34000
      • Istanbul Atlas University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• have reached the age of 18
• Willingness to participate in the study
• Being able to read and write
• Having no problems in verbal communication
• Providing free care

Exclusion Criteria:

• Providing paid care

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; The intervention group will be asked to practice the mandala twice a week, for 30 minutes, for a month. At the end of one month, the scales will be applied again.	Other: Mandala; Mandala work is one of the non-pharmacological approaches and is used to support patients and caregivers in various diseases. Mandala is a method that anyone can apply based on coloring a circular shape.
Placebo Comparator: Control group; Caregivers in the control group will not take any action, and at the end of one month, after the scales have been applied, they will be offered mandala applications.	Other: Routine care; The clinic's routine information will be given to the caregivers of the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
STAI XT-1 State-Trait Anxiety Scale	score anxiety: While the state anxiety scale shows the level of anxiety in a certain situation, the trait anxiety scale evaluates the level of anxiety experienced by the individual regardless of the situation. Scores on both scales range between 20 and 80. High scores indicate high anxiety level, low scores indicate low anxiety level.	4 weeks
Zarit Care Burden Scale	Care Burden Scale: The scale, which can be completed by asking the caregivers themselves or the researcher, consists of 22 statements that determine the impact of caregiving on the individual's life. With this, the caregiver/patient relationship, the caregiver's health status, psychological comfort, social life and economic burden can be evaluated. The evaluation of scale, in which all items are clearly stated, is made on the basis of the total score. As the score increases, the burden of care also increases and a maximum score of 88 is obtained from the scale. Points obtained; It was evaluated by grading as (0-20) little/no burden, (21-40) moderate burden, (41-60) severe burden and (61-88) extreme burden.	4 weeks

Collaborators and Investigators

• Sponsor: Bartın Unıversity

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Actual): February 15, 2024
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Stress, Psychological; Anxiety Disorders; Caregiver Burden
• Other Study ID Numbers: 27042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will be stored in flash memory and shared with other researchers when necessary.

Drug and device information, study documents

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