Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-24 @ 7:25 PM
NCT ID:
NCT07162103
Brief Summary:
The research is being conducted at an elderly day care center between June 12 and August 31, 2025, as a single-blind randomized controlled experimental study using a pre-test, post-test design. Prior to the research, approval was obtained from the scale owners, the participants, the ethics committee, and the institution's implementation permit. The research population consists of 300 individuals registered at the institution. The study sample will consist of 58 individuals (intervention-29 and control-29) who met the inclusion criteria, were selected using the block randomization method, and provided informed consent. The control group will not receive any intervention, and a pre-test will be administered on the first day, and a post-test will be administered on the day the intervention for the experimental group concluded (Week 12). The intervention group will receive 12 sessions of group mandala art therapy once a week, with a pre-test on the first day and a post-test in the last session (Week 12) following the intervention. Data will be collected using the Personal Information Form (PIF) (Appendix 1), Standardized Mini Mental Test, Psychological Well-Being Scale for the Elderly (YPİOÖ), and Loneliness Scale for the Elderly. Data will be analyzed using the SPSS (Statistical Program for Social Sciences) statistical analysis package program, with statistical significance considered at p \<0.05.
Detailed Description:
The problems associated with aging and the increasing elderly population have led to an increase in the healthcare and rehabilitation needs of older individuals, and the psychosocial health of older individuals has become a global public health concern. Elderly individuals living in nursing homes, in particular, need health promotion activities that will improve their emotional well-being, cognitive status, and physical condition, or reduce problematic behaviors. In this context, art therapy, a supportive method aligned with the biopsychosocial approach, is recommended for interventions aimed at protecting and improving the mental health of older individuals. Art therapy, included in the Nursing Intervention Classification, is a supportive method that helps individuals express themselves, acquire coping skills, develop interpersonal skills, increase resilience, resolve conflicts and problems, manage their behaviors, reduce stress, increase self-esteem and self-confidence, and gain insight using art as a tool, all contributing to psychological well-being. Some studies have emphasized the impact of art-related activities on the health of older individuals. According to the literature, utilizing art in individual or group work with older individuals improves their physical and psychosocial health, reduces functional impairments, increases life satisfaction and quality, and enhances self-confidence. It is suggested that mandala creation, a frequently used technique in art therapy, not only provides insight into certain dynamics underlying an individual's subconscious, such as anxiety, fear, and internal conflicts, but also positively impacts the individual's "healing" process. Mandala is considered by art psychotherapists as a psychotherapy technique that provides psychological support and healing.
Maintaining active social relationships among older individuals is important for preventing feelings of loneliness, a symptom of a lack of social relationships, and for increasing psychological well-being. Social relationships can be maintained through close connections with the environment or through hobbies and recreational activities. The purpose of this study is to examine the effects of mandala art therapy group practices on the levels of loneliness and psychological well-being of older individuals living in nursing homes. Consequently, since its inception, nursing has prioritized the holistic healing and recovery of individuals under its care and responsibility, grounded in an existential-humanistic understanding. Since Florence Nightingale, considered the founder of environmental interaction theory and modern nursing, therapeutic management of an individual's environment and setting has held a prominent place among nurses' roles and responsibilities. In this sense, creating a healing/therapeutic environment is a fundamental component of nursing care. In this context, nurses must provide a healing environment enriched with activities to maintain and support the well-being of older individuals, their sense of meaning and purpose in life. Therefore, in the face of a rapidly aging population, encouraging the use of evidence-based interventions to enhance or maintain the well-being of older individuals is crucial. No studies have been found in the literature examining the levels of loneliness and psychological well-being in older individuals using single mandala art therapy. This study has several strengths, including the inclusion of intervention and non-intervention groups, the consistency of the frequency and number of group sessions and materials with the literature, and the examination of comprehensive variables within the life cycle of older adults, such as loneliness and psychological well-being. It is also believed to make significant contributions to the fields of geriatric psychology and art therapy.
In line with the purpose of the study, the hypotheses are as follows:
Hypothesis 1 (H1): Elderly individuals who received group mandala art therapy will have higher post-intervention well-being levels than the control group.
Hypothesis 2 (H1): Elderly individuals who received group mandala art therapy will have lower post-intervention loneliness levels than the control group.
Hypothesis 3 (H1): There is a negative relationship between the well-being and loneliness levels of elderly individuals who received and did not receive group mandala art therapy.
Research Conduct A preliminary study will be conducted with one participant to determine the effectiveness and duration of the measurement tools and group mandala art therapy sessions. The study will be conducted in an elderly daycare center as a single-blind randomized controlled experimental study with a pretest-posttest design. Participants will be provided with an Informed Consent Form and surveys at the beginning of the first session. All participants will complete the surveys at the pretest level and will then be randomized into one of two groups. The control group will not receive any intervention; a posttest will be administered three months after the initial measurements. The control group will also receive the intervention after the research period is concluded. The experimental group will receive the intervention; a posttest will be administered three months after the initial measurements. The study, which will be conducted face-to-face, is planned to consist of twelve (12) sessions, each 90-minute session, once a week for the experimental group. No intervention will be administered to the control group.
Study:
NCT07162103
Study Brief:
Protocol Section:
NCT07162103