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

Bartın Unıversity

Status: Completed

Conditions: Mandala; Caregiver Burden; Anxiety; Caregiver; Palliative Care

Treatments: Other: Routine care; Other: Mandala

Study type: Interventional

Funder types: Other

Identifiers

NCT06132022

27042

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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105 participants in 2 patient groups, including a placebo group

Intervention group

Experimental group

Description:

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.

Treatment:

Other: Mandala

Control group

Placebo Comparator group

Description:

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.

Treatment:

Other: Routine care