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

2018년 3월 21일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

299

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

50년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 요인 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
실험적: 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.
실험적: 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).
다른: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
WHOQOL-BREF
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
SWLS
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Roswiyani Roswiyani, M.Psi, Behavioural Science Institute, Radboud University, The Netherlands; and Tarumanagara University, Jakarta, Indonesia
  • 연구 책임자: Jan Spijker, Prof. dr., Behavioural Science Institute, Radboud University, The Netherlands, and Pro Persona Mental Health Care, Depression Expertise Centre, Nijmegen, the Netherlands
  • 연구 책임자: Cilia Witteman, Prof. dr., Behavioural Science Institute, Radboud University, The Netherlands

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2017년 1월 1일

기본 완료 (실제)

2017년 11월 1일

연구 완료 (실제)

2017년 12월 1일

연구 등록 날짜

최초 제출

2016년 9월 28일

QC 기준을 충족하는 최초 제출

2016년 11월 3일

처음 게시됨 (추정)

2016년 11월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 3월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 3월 21일

마지막으로 확인됨

2016년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • SAAQE-R053

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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