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

Anxiety Clinical Trial

— MANDALAPLIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06132022
• Other study ID #: 27042
• Status: Completed
• Phase: N/A
• Start date: May 31, 2023
• Est. completion date: February 15, 2024

Study information

• Verified date: June 2024
• Source: Bartin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: February 15, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Caregiver
• Caregiver Burden
• Palliative Care

Intervention

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

Locations

Country	Name	City	State
Turkey	Istanbul Atlas University	Istanbul	Kagithane

Sponsors (1)

Lead Sponsor	Collaborator
Bartin University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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