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临床试验/NCT07450924
NCT07450924已完成不适用

Examination of the Effect of Mandala Coloring Activity Applied to Caregivers in the Palliative Care Clinic Along With Benson Relaxation Exercise on Stress, Anxiety and Mental Well-Being

Karadeniz Technical University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2025年3月29日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
1
主要终点
Stress levels of palliative caregivers (Perceived Stress Scale)

研究概览

简要总结

This study aimed to examine the effects of mandala coloring activities, applied in conjunction with Benson relaxation exercises, on the stress, anxiety, and mental well-being of caregivers in a palliative care clinic.

Accordingly, the hypotheses of the study are as follows:

H0a: The combined application of Benson relaxation exercises and mandala coloring activities has no effect on the stress levels of caregivers in a palliative care clinic.

H0b: The combined application of Benson relaxation exercises and mandala coloring activities has no effect on the anxiety levels of caregivers in a palliative care clinic.

H0c: The combined application of Benson relaxation exercises and mandala coloring activities has no effect on the mental well-being of caregivers in a palliative care clinic.

H1a: The combined application of Benson relaxation exercises and mandala coloring activities has an effect on the stress levels of caregivers in a palliative care clinic.

H1b: The combined application of Benson relaxation exercises and mandala coloring activities has an effect on the anxiety levels of caregivers in a palliative care clinic.

H1c: The combined application of Benson relaxation exercises and mandala coloring activities has an effect on the mental well-being of caregivers in a palliative care clinic.

详细描述

This randomized controlled trial, employing a pretest-posttest experimental design, investigated the effects of mandala coloring activities combined with Benson relaxation exercises on the stress, anxiety, and mental well-being of caregivers in a palliative care clinic. The study population consisted of palliative caregivers hospitalized in Palliative Care Ward-1 and Ward-2 at Trabzon Akçaabat Haçkalı Baba State Hospital. The study included two groups: an intervention group and a control group.

The G*Power 3.1 power analysis program was used to determine the sample size. To achieve a power greater than 95%, a total of 40 individuals were required, with 20 in each group (intervention and control), at a 5% significance level and an effect size of 1.198 (df=38; t=2.024). Given the high power of the test and the potential for participant attrition, the study aimed to reach a total of 60 individuals, with 30 in each group. The final study sample consisted of 68 individuals who met the inclusion criteria and participated in the research: 34 in the intervention group and 34 in the control group.

A single-blind randomization method was used to prevent data bias. The computerized randomization program CalculatorSoup was used for this process. The program defined the groups as an intervention group (Benson relaxation exercises and mandala coloring activity group) and a control group, and determined the assignment of participants to these groups.

Before the start of the study, caregivers in both the intervention and control groups completed pretest questionnaires administered face-to-face by the researcher in a quiet environment at the relevant clinic, and their answers were recorded on the relevant forms. The study sample was administered the "Palliative Caregiver Introduction Form" and the pretests: "Perceived Stress Scale", "Anxiety Assessment Scale", and "Warwick-Edinburgh Mental Well-being Scale".

Each caregiver in the intervention group was given a mandala coloring book, a set of colored pencils, an eraser, and a pencil sharpener by the researcher. Additionally, each participant in this group was given an eye mask to use during the Benson relaxation exercises. At the end of the study, these materials were given to the caregivers as gifts. The mandala coloring activity was first demonstrated practically by the researcher to the caregivers in the intervention group in conjunction with the Benson relaxation exercises. For eight days, in a quiet room in the clinic under the researcher's supervision, the caregivers in the intervention group participated in 20 minutes of Benson relaxation exercises and 30 minutes of mandala coloring activity once a day. Caregivers in the control group received no intervention. At the end of the study, the materials were shown and given to caregivers in the control group who wished to participate in mandala coloring activities or Benson relaxation exercises.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Iİnclusion Criteria:
  • Aged 18 years and older
  • Serving as the sole informal caregiver for a palliative care patient
  • Possessing sufficient cognitive level and language proficiency to answer questions
  • Having provided continuous care in a palliative care clinic for at least one week (7 days)
  • Having no vision or hearing problems
  • Being able to use their hands actively
  • Having no allergy to colored pencils
  • Being literate
  • Not using any other non-pharmacological approaches (e.g., herbal treatments, massage, reflexology, meditation, breathing exercises, relaxation exercises, yoga, or acupuncture) during the research period
  • Volunteering to participate in the study

排除标准

  • xclusion Criteria:
  • Under 18 years of age
  • Having a diagnosed illness that could affect cognitive level or language proficiency
  • Not being the sole informal caregiver of a palliative care patient
  • Having visual or hearing problems that would prevent participation in mandala coloring
  • Having a physical disability in the upper extremities
  • Having advanced COPD, asthma, bronchitis, or upper respiratory tract infections

研究组 & 干预措施

control group (n=34)

No Intervention

Caregivers in the control group received no intervention. Before the study, they completed pretest questionnaires administered face-to-face by the researcher in a quiet clinic environment. The control group was given the "Palliative Caregiver Introduction Form (Appendix 1)" and the pretests: "Perceived Stress Scale (Appendix 2)", "Anxiety Assessment Scale (Appendix 3)", and "Warwick-Edinburgh Mental Well-being Scale (Appendix 4)".

At the end of the study, materials were shown and given to control group caregivers who wished to participate in mandala coloring or Benson relaxation exercises. After eight days, all caregivers in the control group completed posttest questionnaires administered by the researcher, consisting of the same three scales (Appendices 2, 3, and 4), and their answers were recorded on the relevant forms.

intervention group (n=34)

Experimental

Before the study began, caregivers in the intervention group completed face-to-face pretests administered by the researcher in a quiet environment, and their responses were recorded on the relevant forms. The intervention group was administered the "Palliative Caregiver Introduction Form (Appendix 1)" and the pretests: "Perceived Stress Scale (Appendix 2)", "Anxiety Assessment Scale (Appendix 3)", and "Warwick-Edinburgh Mental Well-being Scale (Appendix 4)".

Each caregiver was given a mandala coloring book, a set of colored pencils, an eraser, a pencil sharpener, and an eye mask to use during the Benson relaxation exercises. The Benson relaxation exercises and mandala coloring activities were first demonstrated practically by the researcher. For eight days, 20 minutes of Benson relaxation exercises and 30 minutes of mandala coloring were applied daily under the researcher's supervision. At the end of the study, posttests were administered, responses were recorded, and the materials w

干预措施: mandala coloring activity (Behavioral)

intervention group (n=34)

Experimental

Before the study began, caregivers in the intervention group completed face-to-face pretests administered by the researcher in a quiet environment, and their responses were recorded on the relevant forms. The intervention group was administered the "Palliative Caregiver Introduction Form (Appendix 1)" and the pretests: "Perceived Stress Scale (Appendix 2)", "Anxiety Assessment Scale (Appendix 3)", and "Warwick-Edinburgh Mental Well-being Scale (Appendix 4)".

Each caregiver was given a mandala coloring book, a set of colored pencils, an eraser, a pencil sharpener, and an eye mask to use during the Benson relaxation exercises. The Benson relaxation exercises and mandala coloring activities were first demonstrated practically by the researcher. For eight days, 20 minutes of Benson relaxation exercises and 30 minutes of mandala coloring were applied daily under the researcher's supervision. At the end of the study, posttests were administered, responses were recorded, and the materials w

干预措施: Benson relaxation exercises (Behavioral)

结局指标

主要结局

Stress levels of palliative caregivers (Perceived Stress Scale)

时间窗: Before intervention (day 0) and after intervention (day 8)

Changes in palliative caregivers' Perceived Stress Scale scores were measured before and 8 days after the implementation of the BRT combined with the MCA.

次要结局

  • Anxiety levels of palliative caregivers (Anxiety Assessment Scale)(Before intervention (Day 0) and after intervention (Day 8))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

bahrican güven

NURSE

Karadeniz Technical University

研究点 (1)

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