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Completed

NCT Number: NCT06132022

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Atlas University

Istanbul, Kağıthane, 34000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mandala

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.

Routine care

Other

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

Primary outcomes

  1. STAI XT-1 State-Trait Anxiety Scale

    Time frame: 4 weeks

    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.

  2. Zarit Care Burden Scale

    Time frame: 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

Bartın Unıversity

Other

Registry information

Official study title

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

Acronym: MANDALAPLİC

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 15, 2023
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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