此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Integration of Social Art Activities and Qigong for Older People in Nursing Home in Indonesia

2018年3月21日 更新者:Radboud University Medical Center

Integration of Social Art Activities and Qigong Exercises to Increase the Well-Being of Older People in Nursing Homes in Indonesia

This project will be a randomised controlled trial to investigate the effectiveness of an integrated programme by using social art activity (SA) and exercise, for instance, Qigong (QG, a traditional Chinese exercise) as a therapeutic medium.

This integrated programme aims to increase the well-being and reduce the depressive symptoms that are frequently ascertained in older people who live in nursing homes. The combination of SA and QG might be more beneficial to older people than either individual activity on its own, given that they are addressing different areas of functioning. The art activity focuses on self-expression in non-verbal activity using fine motor movement, whereas physical exercise like Qigong focuses on awareness of breathing and a calm state of mind. This is to help the older person achieve mental and physical relaxation by using gross motor movement. When the interventions are combined by utilising Qigong ahead of the art activities (thus, including both fine and gross motor movements) older people will reach a state of mental and physical relaxation, and moreover, will be able to express their feelings more simply in the social art activities.

研究概览

详细说明

Depression is one of the most common mental disorders with regards to older people. It is a serious disease affecting an individual's entire life-situation, which can lead to suffering and a reduced level of activity in everyday life. Depression inhibits thinking capacity in self-expression and reduces the ability to communicate. Furthermore, older people with depression often use a considerable amount of energy attempting to avoid distressing emotions and negative thinking, which is one of the principal symptoms of depression.

Research findings describing the use of relaxation or meditation to prepare clients prior to the art activities are effective treatment methods in the reduction of depression and anxiety. However, adding Qigong as an initial therapy prior to the art activities enhances the effectiveness of art therapy. When older people achieve deep states of mental and physical relaxation, they will be able to activate their thinking capacity regarding self-expression by means of the use of art media. Thus, their negative feelings will be directed toward art activities, which in turn will reduce the depressive feelings.

This study is conducted as a randomised controlled trial with four groups. The four groups will be (1) Qigong exercise and art activity group as an integrated intervention (2) An art activity group; (3) A Qigong group; and (4) no intervention/daily activities. The investigators begins by allocating participants at random to one of the intervention groups. The process of randomising the participants will be collected by sealed-envelopes used in the selection process. The participants will assemble in one room and each participant will receive a sealed-envelope, which contains a card labelled with information regarding the intervention that will follow. The information will comprise the number of sessions, time period and checklist column that must be marked by the participants, in order to indicate that they are willing to follow the intervention. Once the participants know the intervention group that they are assigned to, the investigators will conduct an initial interview to obtain demographic information and to acquire data about the reason they decided to live in a nursing home. Finally, informed consent will be obtained from the participants during the initial interview. The intervention will be conducted in 8 weeks and consists of 16 sessions that will be given twice a week; each session will be last for 90 minutes.

Furthermore, the investigators will evaluate participants who meet the criteria before the intervention. The measurement of the inclusion and exclusion criteria will be assessed by using MMSE and the MINI Neuropsychiatric Interview. Social demographic characteristics are included to collect data about age, sex and ethnicity, education, marital status (married or never married), family group, perceived economic status (upper, middle or lower), financial resources, medical history, lifestyle/exercise habits and information relating to admission to the nursing home. The MMSE is a brief indicator of cognitive ability of the elderly, and the MINI will be used as a screening tool to measure severe psychiatric disorders. The measurements will be given before and after the intervention using WHOQOL-BREF; SWLS, BDI-II and GDS 15-item, MMSE and SF-36.

The intervention process of the social art activities will be provided and participants will use art materials, for instance, drawing paper, pencils and coloured pencils, magazine, objects, glue, scissors/box cutters, collage and additional material. The materials are selected based on the consideration that they are not too messy or too complicated to work with. The Qigong consists of nine simple and slow movements that are suitable for older people. The integrated intervention will be presented in one session; hence, Qigong will be provided as the initial therapeutic activity preceding the art activities. The healing mechanisms to depressed older people using the art activities and Qigong can be obtained during the "therapeutic process", which consists of sensory stimulation, self-exploration, self-expression, communication, understanding and explanation, symbolic thinking and creativity.

During the intervention, participants will be observed based on the observation form, to know if there is any improvement in social interaction, communication and involvement in the activities, in addition to their expression and impression during the activities. A follow-up measurement will take place 3 and 6 months after the intervention, including a follow-up interview to obtain descriptive data concerning the older person's well-being, following participation in the intervention.

The control condition consists of groups of older people engaged in regular, daily activities, for instance, watching television or just sitting and reading. The participants do activities on a regular basis in nursing homes and they are not receiving any therapeutic interventions, as above. Therefore, the investigators may consider these groups as the no-treatment groups. In addition, the participants will be assembled in one room for approximately 90 minutes and they could choose to participate in daily activities in the groups.

研究类型

介入性

注册 (实际的)

299

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Aged 50 years or older
  • Deemed to be cognitively capable of participating in an in-depth interview
  • Admitted to the nursing home at least 3 months ago
  • Healthy physical condition (able to walk and to do daily activity without assistance)
  • Consent to randomization and follow-up.

Exclusion Criteria:

  • Severe cognitive impairment or dementia based on MMSE
  • Blind and have severe hearing or speech impairment that might interfere with participation in the interview
  • Psychotic disorders based on MINI Neuropsychiatric Interview (Sheehan et al., 1998)
  • Severe physical disorder
  • Severe communication problem
  • Alcohol/drug misuse.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:阶乘赋值
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Qigong and art activities
An integrated group of Qigong and art activities for 90 minutes.
Participants join a 90-minute session of integrated Qigong and art activity consisting of 30 minutes Qigong followed by 60 minutes art activity.
实验性的:Art activities
Art activities and daily activities group for 90 minutes.
Participants join a 90-minute session that consists of 60-minute art activities followed by 30 minutes daily activities.
实验性的:Qigong
A Qigong and daily activities group for 90 minutes
Participants join a 90-minute session that consists of 30-minutes Qigong exercise followed by 60 minutes daily activities (watching television, reading or sitting together).
其他:Daily activities
A daily activities group for 90-minutes.
Participants do their daily activities routine for 90-minutes, such as watching television, reading and sitting together or participants can do free individual activities on their own.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
WHOQOL-BREF
大体时间:Change from Baseline to 8 weeks, 3 and 6 months
The brief version of the World Health Organization Quality of Life (WHOQOL-BREF) (The WHO Group, 1998) was developed to assess the quality of life. It contains a total of 26 questions. All items are rated on a five-point Likert scale using response categories such as 1 represents very poor, and 5 represents very well with the statement. The instrument consists of four domains: psychological health, physiological health, social relationships, and environmental health. The test - re-test reliability for WHOQOL-BREF lies within 0.81 to 0.90.
Change from Baseline to 8 weeks, 3 and 6 months

次要结果测量

结果测量
措施说明
大体时间
SWLS
大体时间:Change from Baseline to 8 weeks, 3 and 6 months
The satisfaction with life scale (SWLS) (Diener, 1984) was developed to assess satisfaction with the respondent's life as a whole. It consists of five statements that the client could either agree or disagree with on a scale of 1 - 7, where 1 represents strongly disagree, and 7 represents strongly agree with the statement. Diener (1985) reported a Cronbach's alpha of 0.87 for the scale and a test - retest stability coefficient of 0.82.
Change from Baseline to 8 weeks, 3 and 6 months
The Indo BDI-II
大体时间:Change from Baseline to 8 weeks, 3 and 6 months
Beck Depression Inventory-II for Indonesian general population (Beck, Steer, & Brown, 1996; Ginting, Näring, van der Veld, Srisayekti & Becker, 2013), contains 21-item self-report inventory measuring the severity of depression in adolescents and adults. All items are rated on a 4-point Likert-type scale ranging from 0 to 3, based on the severity of each item. Cronbach's alpha of the Indo BDI-II per group was .90 for healthy participants, and .91 for depressed patients. The test-retest correlation of the Indo BDI-II was significant (r = .55, p < .01).
Change from Baseline to 8 weeks, 3 and 6 months
GDS-15
大体时间:Change from Baseline to 8 weeks, 3 and 6 months
Geriatric Depression Scale 15-item (GDS 15-item) adapted from the Sheikh and Yesavage (1986). The GDS was designed as a screening tool for depression in elderly populations. It consists of 15 questions with YES or NO answer; where YES was treated as 0 and NO-treated as 1. A score > 5 point is suggestive of depression. The Cronbach's α coefficient was 0,71.
Change from Baseline to 8 weeks, 3 and 6 months
MMSE
大体时间:Change from Baseline to 8 weeks, 3 and 6 months
Mini-Mental State Exam (MMSE; Folstein, Folstein, & McHugh, 1975) used as a brief indicator of cognitive status. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment.
Change from Baseline to 8 weeks, 3 and 6 months
SF-36
大体时间:Change from Baseline to 8 weeks, 3 and 6 months
A 36-item short-form (SF-36; Ware Jr, 1993; Perwitasari, 2012) is a widely used questionnaire for measuring self-reported physical and mental health status. It is a short-form health survey with only 36 questions. Estimates of reliability in the physical and mental sections are typically above 0.90.
Change from Baseline to 8 weeks, 3 and 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Roswiyani Roswiyani, M.Psi、Behavioural Science Institute, Radboud University, The Netherlands; and Tarumanagara University, Jakarta, Indonesia
  • 研究主任:Jan Spijker, Prof. dr.、Behavioural Science Institute, Radboud University, The Netherlands, and Pro Persona Mental Health Care, Depression Expertise Centre, Nijmegen, the Netherlands
  • 研究主任:Cilia Witteman, Prof. dr.、Behavioural Science Institute, Radboud University, The Netherlands

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2017年1月1日

初级完成 (实际的)

2017年11月1日

研究完成 (实际的)

2017年12月1日

研究注册日期

首次提交

2016年9月28日

首先提交符合 QC 标准的

2016年11月3日

首次发布 (估计)

2016年11月8日

研究记录更新

最后更新发布 (实际的)

2018年3月23日

上次提交的符合 QC 标准的更新

2018年3月21日

最后验证

2016年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • SAAQE-R053

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅