- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07450924
The Effect of Benson Relaxation Exercise and Mandala Coloring Activity on Stress, Anxiety, and Mental Health of Palliative Caregivers (Benson Relaxation Technique (BRT), Mandala Coloring Activity (MCA)) (BRT MCA)
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
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Eight days later, all caregivers in the sample completed posttests administered by the researcher. The Statistical Package for Social Sciences (SPSS) 25.0 program was used for coding and statistical analysis of the data obtained from the study. Before applying the tests, the normality of the data distribution was examined using the Kolmogorov-Smirnov test and was considered normal at a 95% confidence interval and p > 0.05 level. Percentage, mean, and standard deviation calculations were performed to describe the demographic characteristics of palliative caregivers and patients. Chi-square and Fisher's Exactness tests were used in analyses based on the nominal data of the caregivers. To compare the pretest and posttest mean scores of the intervention and control groups, independent t-tests and Mann-Whitney U tests were applied for independent samples, while paired t-tests, Wilcoxon tests, and Chi-square tests were applied for dependent samples.
In the analyses, the statistical significance of the effect size was evaluated using Cohen's d and r values. According to Cohen's interpretation of effect size, a d value below 0.2 indicates a small effect, 0.5 a moderate effect, and 0.8 a large effect. Effect size calculations were performed using data from an online calculator. For non-parametric tests, effect size was determined using the r value, and regardless of the r sign, 0.10 was interpreted as a small effect, 0.30 as a moderate effect, and 0.50 as a large effect. In addition, the explained variance of the dependent variable on the independent variable was evaluated using the R² value.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Trabzon, Turkey (Türkiye)
- Karadeniz Technical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Exclusion 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group (n=34)
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. |
|
|
Experimental: intervention group (n=34)
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 |
Mandala coloring is an art therapy method that allows individuals to express their inner world by coloring circular and symmetrical patterns.
According to Carl Jung, the mandala represents the subconscious and symbolizes an individual's inner integrity, with drawings reflecting a person's self-perception and mood.
Structured mandalas are accessible and low-threatening in clinical settings.
The activity is typically conducted in short sessions where participants choose the patterns and colors they wish to use.
The coloring process promotes meditation and awareness, providing mental calmness and helping individuals recognize their emotions and values while offering a sense of control and accomplishment during chaotic situations.
As a safe, time-efficient, and self-management tool requiring no special skills, mandala coloring contributes to reducing stress and anxiety, making it an effective complementary practice for palliative caregivers.
Other Names:
The Benson Relaxation Technique (BRT) is a behavioral intervention designed to elicit a "relaxation response" through breath regulation, cognitive focus, and the repetition of words or phrases.
This response, which is the physiological opposite of the stress reaction, reduces heart rate, respiration, blood pressure, and muscle tension while lowering stress hormones and promoting mental calmness.
BRT is practiced in a quiet environment, in a comfortable position with eyes closed, for 10 to 20 minutes.
Participants focus on their breath, repeat a chosen word silently, and acknowledge and release distracting thoughts.
Clinical studies have demonstrated that BRT reduces anxiety, depression, perceived stress, and fatigue, while improving sleep quality and contributing to overall quality of life.
It is a safe, low-cost, and accessible stress management method for palliative caregivers.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Stress levels of palliative caregivers (Perceived Stress Scale)
Time Frame: Before intervention (day 0) and after intervention (day 8)
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Changes in palliative caregivers' Perceived Stress Scale scores were measured before and 8 days after the implementation of the BRT combined with the MCA.
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Before intervention (day 0) and after intervention (day 8)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Anxiety levels of palliative caregivers (Anxiety Assessment Scale)
Time Frame: Before intervention (Day 0) and after intervention (Day 8)
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Changes in palliative caregivers' Anxiety Assessment Scale scores were measured before and 8 days after the implementation of the BRT combined with MCA.
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Before intervention (Day 0) and after intervention (Day 8)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Palliative caregivers' mental health score (Warwick-Edinburgh Mental Health Scale)
Time Frame: Before intervention (Day 0) and after intervention (Day 8)
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Changes in Warwick-Edinburgh Mental Well-being Scale scores were measured in palliative caregivers before and 8 days after the implementation of the BRT combined with MCA.
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Before intervention (Day 0) and after intervention (Day 8)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
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- Duracak A, Özmen D (2023). Palyatif bakım hastalarına bakım verenlerin spiritüel iyi oluş ve depresyon düzeylerinin bakım yüklerine etkisi. İzmir Katip Çelebi Üniversitesi Sağlık Bilimleri Fakültesi Dergisi 8(2):387-393.
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- Benson H, Beary JF, Carol MP (1974). The relaxation response. Psychiatry 37(1):37-46.
- Harorani M, Davodabady F, Farahani Z, Rafiei F (2020). The effect of Benson's relaxation response on sleep quality and anorexia in cancer patients undergoing chemotherapy: A randomized controlled trial. Complementary Therapies in Medicine 50:102344.
- Khademi F, Rassouli M, Rafiei F, Moayedi S, Torres M, Marzban N, Golitaleb M. (2021). The effect of mandala colouring on anxiety in hospitalized COVID-19 patients: A randomized controlled clinical trial. International Journal of Mental Health Nursing 30(Suppl 1):1437-1444.
- Maharjan G, Baby L (2019). A study to assess the effectiveness of progressive muscle relaxation on stress among nursing students in a selected nursing college, Bangalore. International Journal of Health Sciences and Research 9(11):150-158.
- Ashlock LE, Miller-Perrin C, Krumrei-Mancuso E (2018). The effectiveness of structured coloring activities for anxiety reduction. Art Therapy 35(4):195-201.
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- Ebrahimloee S, Masoumpoor A, Nasiri M, Babaie M, Farahani AV, Yousefiasl S, Farahani AS (2022). The effect of Benson relaxation technique on the severity of symptoms and quality of life in children with irritable bowel syndrome (IBS): a quasi-experimental study. BMC Gastroenterology 22(1):547.
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- Yılmaz UD, Dilemek H, Yılmaz D, Korhan EA, Çelik E, Rastgel H (2017). Hemşirelerin bakım verici rollerine ilişkin tutumları ve ilişkili faktörler. Uluslararası Hakemli Hemşirelik Araştırmaları Dergisi 10:83-100.
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- Kivanc MM (2017). Türkiye'de palyatif bakım hizmetleri. Sağlık Bilimleri ve Meslekleri Dergisi 4(2):132-136.
- World Health Organization (2023). Palliative care. [online]. Available from: https://www.who.int/europe/news-room/fact-sheets/item/palliative-care. [Accessed 14 November 2024].
- Maciver J, Ross HJ (2018). A palliative approach for heart failure end-of-life care. Current Opinion in Cardiology 33(2): 202-207.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavior
- Motor Activity
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Exercise Movement Techniques
- Physical Therapy Modalities
- Patient Care
- Psychotherapy
- Behavioral Disciplines and Activities
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Sensory Art Therapies
- Exercise
- Breathing Exercises
- Art Therapy
Other Study ID Numbers
- KTU-SBE-HEM-BGE-MND-2025-01
- TYL-2025-16411; BAP06 (Other Grant/Funding Number: Republic of Turkey, Black Sea Technical University, Scientific Research Projects Coordination Unit)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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