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

NCT ID: NCT06132022

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2024-02-15

Brief Summary

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.

Conditions

Palliative Care; Caregiver; Anxiety; Mandala; Caregiver Burden

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mandala

Intervention Type: OTHER

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.

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.

Group Type: PLACEBO_COMPARATOR

Routine care

Intervention Type: OTHER

The clinic's routine information will be given to the caregivers of the control group.

Interventions

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.

Intervention Type: OTHER

Routine care

The clinic's routine information will be given to the caregivers of the control group.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bartın Unıversity

OTHER

Sponsor Role: lead

Responsible Party

Necmiye ÇÖMLEKÇİ

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul Atlas University

Istanbul, Kağıthane, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

27042

Identifier Type: -

Identifier Source: org_study_id