Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05847231
Other study ID # 2023/ 05- 08
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 25, 2023
Est. completion date November 30, 2023

Study information

Verified date January 2024
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The word palliative comes from the Latin word "pallium" meaning "cover". The aim of palliative care is not to eliminate the cause of the disease; to alleviate the negative effects of the disease. Mandala painting, which is one of the non-pharmacological applications, is an art therapy technique that can provide psychological support and healing. Mandala painting is a safe and accessible activity that requires no special skills and can be used as a complementary strategy to support mental health. In the literature, it is stated that coloring mandala improves psychological symptoms and relieves the person. The artistic view of nursing is to understand the needs of the individual, the sources of anxiety, anxiety and stress, and then to develop practices that will increase his/her self-confidence and resilience by increasing his/her ability and competence level. Therefore, this study was planned to examine the effect of mandala painting applied to caregivers caring for palliative care patients on perceived stress, anxiety level and quality of life. This research, which is planned as a randomized experimental study with pretest-posttest control group, will be a study for informal caregivers who have patients in the palliative service of fethi sekin city hospital between May 2023 and December 2023. The sample will consist of 80 (40 experimental, 40 control) caregivers who accepted the research that met the research criteria. Experimental group will be composed of caregivers who will paint mandalas. In addition to verbal and written information, the Patient Description Form, Perceived Stress Scale (PSÖ), State-Trait Anxiety Scale (WHO) and Short Form (SF-36) Quality of Life Scale have been applied to the 1st Stage. measurement will be obtained. The program will be implemented for 4 weeks, 4 days a week. 16 pre-selected mandala drawings will be printed separately on A4 papers and a new drawing will be given to caregivers every week. Mandala coloring papers and 12 colored felt-tip crayons will be given to each participant by the researcher. After the end of the sessions, the second measurements will be obtained by applying the Perceived Stress Scale (PSS), State-Trait Anxiety Scale (DSQ) and Short Form-36 (SF-36) Quality of Life Scale.


Description:

The palliative care approach first emerged in the 11th century as a religious-based volunteer movement for the treatment of people suffering from terminal illnesses during long journeys. Although the quality of patient care changes all over the world, there is definitely a section in care that includes the responsibilities of the family. It is stated in the literature that the anxiety levels of the patient and family members who receive the necessary information and support about the disease decrease. The caregiving process is a very stressful situation for the caregiver, which can lead to physical and psychological problems. Anxiety levels of caregivers also increase due to the caregiving process that creates excessive stress and anxiety. Studies in which caregivers have high levels of anxiety due to the burden of care come to the fore in the literature. Mandala provides calming and relaxation as your mind. It silences the negative and complex emotions that bother the person himself. With the relaxation it provides, it allows the individual to listen to himself and to rest spiritually. Mandala allows to see holistically. While increasing one's awareness, it reveals what is hidden in the unconscious. Art therapy helps individuals feel themselves at the center of their lives, express themselves and discover who they are in the group while drawing, painting or making mandalas. Jung stated that he created mandalas in times of distress when both he and his patients felt negative emotions. İn the previous studies; Mandala art therapy has been used to define psychiatric problems in children, to reduce stress and to calm down, to provide concentration and psychological relaxation, and positive results have been obtained.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date November 30, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - be over 18 years old - Palliative care patient being the only informal caregiver - There is no physical problem that will prevent painting mandala. (seeing, hearing, etc.) - Being able to use their hands actively - No communication problem - No learning problems - Being suitable/willing to work with the group Exclusion Criteria: - be under the age of 18 - Palliative care patient is not the only informal caregiver - Having a physical problem that will prevent you from painting a mandala (sight, hearing, etc.) - Having a physical disability in the upper extremity of the caregiver - Having trouble communicating - Having a learning problem - It does not show the harmony of working with the group.

Study Design


Intervention

Behavioral:
Perceived Stress, Mandala application
Mandala

Locations

Country Name City State
Turkey Gülcan B.Turan Elazig Merkez

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other SF-36 Quality of Life Scale The scale consists of 36 questions and consists of physical functionality (10 questions), social functionality (2 questions), physical role restrictions (4 questions), emotional role restrictions (3 questions), mental health (5 questions), energy/vitality (4 questions), pain (2 questions), general health perception (5 questions). The answers to the questions are in 2, 3, 5, and 6 point likert type. Scoring of the scale takes place in two stages. In the first stage, 0 represents the lowest quality of life value and 100 represents the highest quality of life value. In the second stage, scores for each dimension are obtained. A score close to 0 indicates undesirable poor health, and closer to 100 indicates desired good health. after 1 hour in mandala app
Primary Perceived Stress Scale (PSS)Perceived Stress Scale (PSS) It is designed to measure how stressful individuals perceive their experiences, including their feelings and thoughts that they may have experienced during the last month. The total score that can be obtained from the scale is 32. The scale consists of 8 items. These items are scored by the individual in a 5-point Likert type (0=Never,1=Rarely,2=Sometimes,3=Frequently, 4=Very often) according to their intensity of experience. While five items of the scale are plain (1st, 2nd, 3rd, 7th, 8th items); three items are reversed (items 4, 5, 6). It has two subscales: perceived stress (1st, 2nd, 3rd, 7th, 8th items) and perceived coping (4th, 5th, 6th items). after 1 hour in mandala app
Secondary State-Trait Anxiety Inventory (WHO) n this study, the part of the scale measuring trait anxiety was used to determine the trait anxiety levels of the patients. Trait Anxiety Inventory is a 4-point Likert-type with 20 items and is scored as "never": 1, "a little": 2, "a lot": 3, "completely": 4, according to the degree of severity of the feelings, thoughts or behaviors expressed by the items. . There are direct or reverse scored statements in the scale. Reverse scored statements; Items 1, 6, 7, 10, 13, 16 and 19. Trait anxiety score is obtained by adding the constant value of 35, which is the constant value of the trait anxiety scale, to the value obtained by subtracting the total score of the reverse scored statements from the total score of the direct statements. The lowest score that can be obtained from the scale is 20, and the highest score is 80. A high score indicates a high level of anxiety, a low score indicates a low level of anxiety. after 1 hour in mandala app
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT06238557 - Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT05472935 - Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers N/A
Recruiting NCT04444544 - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed NCT04281953 - Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
Recruiting NCT05546931 - Mobile Health Program for Rural Hypertension N/A
Active, not recruiting NCT04746664 - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia N/A
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Recruiting NCT04142827 - The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX) N/A
Active, not recruiting NCT05903638 - A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT03813420 - Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level N/A
Recruiting NCT05550545 - Infant RSV Infections and Health-related Quality of Life of Families
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Recruiting NCT05233020 - Robotic Versus Hybrid Assisted Ventral Hernia Repair N/A
Terminated NCT03304184 - The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life Phase 3
Completed NCT05063305 - Probiotics, Immunity, Stress, and QofL N/A
Recruiting NCT05380856 - Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction N/A