Clinical trial NCT06132022: The Effect of Mandala Application on Anxiety Level and Caregiver Burden in Palliative Care
Official title: The Effect of Mandala Application on Anxiety Level and Caregiver Burden in Palliative Caregivers: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palliative Care
Caregiver
Anxiety
Mandala
Caregiver Burden
Lead sponsor: Bartın Unıversity
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Rondomized Controlled Trial
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: STAI XT-1 State-Trait Anxiety Scale
timeFrame: 4 weeks
measure: Zarit Care Burden Scale
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Atlas University
state: Kağıthane
Study officials:
References: