Benson ExerciseBRT MCANCT07450924
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))
A study testing mandala coloring activity and Benson relaxation exercises in people with Benson Exercise and Mandala Coloring, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Benson Exercise, Mandala Coloring, Informal Palliative Caregiver
- What is being tested?
- mandala coloring activity and Benson relaxation exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Mar 2025to 27 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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.
Read the 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.
- Being tested
- mandala coloring activity, Benson relaxation exercises
- Keywords
- Art therapy, exercise, muscle relaxation, nursing, palliative care
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mandala coloring activityBehavioural
Also called art therapy, mandala coloring, colored therapy
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.
Benson relaxation exercisesBehavioural
Also called relaxation exercises, breathing exercises, exercises, relaxation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: mandala coloring activity; Behavioral: Benson relaxation exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress levels of palliative caregivers (Perceived Stress Scale)
Changes in palliative caregivers' Perceived Stress Scale scores were measured before and 8 days after the implementation of the BRT combined with the MCA.
Measured: Before intervention (day 0) and after intervention (day 8)
Secondary outcomes (1)
Anxiety levels of palliative caregivers (Anxiety Assessment Scale)
Changes in palliative caregivers' Anxiety Assessment Scale scores were measured before and 8 days after the implementation of the BRT combined with MCA.
Measured: Before intervention (Day 0) and after intervention (Day 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start29 Mar 2025
- Primary completion10 May 2025
- Study completion27 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Benson ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research was conducted using a randomized controlled, pretest-posttest design and an experimental design.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, bahrican güven, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450924
- Sponsor's protocol ID
- KTU-SBE-HEM-BGE-MND-2025-01
- Other IDs
- TYL-2025-16411; BAP06
- Acronym
- BRT MCA
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant confidentiality was strictly maintained throughout the study. All personal and clinical data were anonymized by assigning unique identification codes to each participant, and no identifying information was included in the data collection forms or analysis. Study data were accessible only to the research team and were stored securely in accordance with institutional and ethical guidelines. The results were reported in aggregate form to ensure that individual participants could not be identified.
Publications
George D, Mallery M. (2010). SPSS for Windows step by step: A simple guide and reference, 17.0 update (10a ed.). Boston: Pearson Education India.
Demirtaş AS, Baytemir K (2019). Warwick-Edinburgh mental iyi oluş ölçeği kısa formu'nun Türkçe'ye uyarlanması: Geçerlik ve güvenirlik çalişması. Elektronik Sosyal Bilimler Dergisi 18(70):689-701.
Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.
PubMed 18042300Malakcioglu C. Validity and Reliability of the Anxiety Assessment Scale: A New Three-dimensional Perspective. Medeni Med J. 2022 Jun 23;37(2):165-172. doi: 10.4274/MMJ.galenos.2022.75318.
PubMed 35735160Bilge A, Öğce F, Genç RE, Oran NT (2009). Algılanan stres ölçeği (ASÖ)'nin Türkçe versiyonunun psikometrik uygunluğu. Ege Üniversitesi Hemşirelik Yüksekokulu Dergisi 2(25):61-72.
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Ay S (2017). Yaşlı hastalara bakım verenlerin bakım verme yükleri ve başa çıkma biçimleri ile depresyon ve anksiyete düzeyleri arasındaki ilişkinin değerlendirilmesi. Yüksek lisans tezi, Sosyal Bilimler Enstitüsü Klinik Psikoloji Anabilim Dalı, İstanbul
Bilgehan T, İnkaya B (2021). Palyatif hastalarına bakım veren bireylerin bakım yükü ve etkileyen faktörler. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi 24(1):51-58.
Kahraman B (2023). Palyatif bakım ünitesinde tedavi gören hastalara bakım veren bireylerin bakım verme yükü ve depresyon anksiyete stres düzeylerinin incelenmesi. Yüksek lisans tezi, İstanbul Sabahattin Zaim Üniversitesi Hemşirelik Anabilim Dalı İç Hastalıkları Hemşireliği Bilim Dalı, İstanbul.
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.
Yildiz E, Dedeli Ö, Pakyüz SÇ (2016). Kanser hastalarına bakım veren aile üyelerinin bakım yükü ve yaşam kalitesinin incelenmesi. Hemşirelikte Eğitim ve Araştırma Dergisi 13(3):216-225.
Budak S (2019). Palyatif bakım alan PEG (perkütan endoskopik gastrostomi) ve NG (nazogastrik)'li hastalara bakım verenlerin bakım yükü ve yaşam kalitesinin incelenmesi. Yüksek lisans tezi, Balıkesir Üniversitesi Sağlık Bilimleri Enstitüsü, Hemşirelik Anabilim Dalı, Balıkesir.
Benson H, Beary JF, Carol MP. The relaxation response. Psychiatry. 1974 Feb;37(1):37-46. doi: 10.1080/00332747.1974.11023785. No abstract available.
PubMed 4810622Harorani M, Davodabady F, Farahani Z, Hezave AK, Rafiei F. The effect of Benson's relaxation response on sleep quality and anorexia in cancer patients undergoing chemotherapy: A randomized controlled trial. Complement Ther Med. 2020 May;50:102344. doi: 10.1016/j.ctim.2020.102344. Epub 2020 Feb 21.
PubMed 32444038Khademi F, Rassouli M, Rafiei F, Moayedi S, Torres M, Marzban N, Haji E, Golitaleb M. The effect of mandala colouring on anxiety in hospitalized COVID-19 patients: A randomized controlled clinical trial. Int J Ment Health Nurs. 2021 Oct;30 Suppl 1(Suppl 1):1437-1444. doi: 10.1111/inm.12901. Epub 2021 Jun 18.
PubMed 34143568
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07450924
- Acronym / sponsor ID
- BRT MCA / KTU-SBE-HEM-BGE-MND-2025-01
- Keywords
- Art therapy, exercise, muscle relaxation, nursing, palliative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 29 Mar 2025 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 27 Sep 2025 (actual)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The research was conducted using a randomized controlled, pretest-posttest design and an experimental design.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: mandala coloring activity, Behavioral: Benson relaxation exercisesBefore 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mandala coloring activityAlso: art therapy, mandala coloring, colored therapyMandala 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. | Behavioural | intervention group (n=34) |
| Benson relaxation exercisesAlso: relaxation exercises, breathing exercises, exercises, relaxationThe 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. | Behavioural | intervention group (n=34) |
Primary outcome
Stress levels of palliative caregivers (Perceived Stress Scale)
Time frame: 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.
1 secondary outcome
Anxiety levels of palliative caregivers (Anxiety Assessment Scale)
Time frame: Before intervention (Day 0) and after intervention (Day 8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- BackgroundGeorge D, Mallery M. (2010). SPSS for Windows step by step: A simple guide and reference, 17.0 update (10a ed.). Boston: Pearson Education India.
- BackgroundDemirtaş AS, Baytemir K (2019). Warwick-Edinburgh mental iyi oluş ölçeği kısa formu'nun Türkçe'ye uyarlanması: Geçerlik ve güvenirlik çalişması. Elektronik Sosyal Bilimler Dergisi 18(70):689-701.
- Background: PubMed 18042300Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.
- Background: PubMed 35735160Malakcioglu C. Validity and Reliability of the Anxiety Assessment Scale: A New Three-dimensional Perspective. Medeni Med J. 2022 Jun 23;37(2):165-172. doi: 10.4274/MMJ.galenos.2022.75318.
- BackgroundBilge A, Öğce F, Genç RE, Oran NT (2009). Algılanan stres ölçeği (ASÖ)'nin Türkçe versiyonunun psikometrik uygunluğu. Ege Üniversitesi Hemşirelik Yüksekokulu Dergisi 2(25):61-72.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- BackgroundAy S (2017). Yaşlı hastalara bakım verenlerin bakım verme yükleri ve başa çıkma biçimleri ile depresyon ve anksiyete düzeyleri arasındaki ilişkinin değerlendirilmesi. Yüksek lisans tezi, Sosyal Bilimler Enstitüsü Klinik Psikoloji Anabilim Dalı, İstanbul
- BackgroundBilgehan T, İnkaya B (2021). Palyatif hastalarına bakım veren bireylerin bakım yükü ve etkileyen faktörler. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi 24(1):51-58.
- BackgroundKahraman B (2023). Palyatif bakım ünitesinde tedavi gören hastalara bakım veren bireylerin bakım verme yükü ve depresyon anksiyete stres düzeylerinin incelenmesi. Yüksek lisans tezi, İstanbul Sabahattin Zaim Üniversitesi Hemşirelik Anabilim Dalı İç Hastalıkları Hemşireliği Bilim Dalı, İstanbul.
- BackgroundDuracak 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.
- BackgroundYildiz E, Dedeli Ö, Pakyüz SÇ (2016). Kanser hastalarına bakım veren aile üyelerinin bakım yükü ve yaşam kalitesinin incelenmesi. Hemşirelikte Eğitim ve Araştırma Dergisi 13(3):216-225.
- BackgroundBudak S (2019). Palyatif bakım alan PEG (perkütan endoskopik gastrostomi) ve NG (nazogastrik)'li hastalara bakım verenlerin bakım yükü ve yaşam kalitesinin incelenmesi. Yüksek lisans tezi, Balıkesir Üniversitesi Sağlık Bilimleri Enstitüsü, Hemşirelik Anabilim Dalı, Balıkesir.
- Individual participant dataSharing planned: No. Participant confidentiality was strictly maintained throughout the study. All personal and clinical data were anonymized by assigning unique identification codes to each participant, and no identifying information was included in the data collection forms or analysis. Study data were accessible only to the research team and were stored securely in accordance with institutional and ethical guidelines. The results were reported in aggregate form to ensure that individual participants could not be identified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mandala coloring activity and Benson relaxation exercises in people with Benson Exercise and Mandala Coloring, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress levels of palliative caregivers (Perceived Stress Scale) (time frame: Before intervention (day 0) and after intervention (day 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07450924, which also lists 41 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.