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

21 marzo 2018 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

299

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

50 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione fattoriale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Sperimentale: 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.
Sperimentale: 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).
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
WHOQOL-BREF
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
SWLS
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Collaboratori

Investigatori

  • Investigatore principale: Roswiyani Roswiyani, M.Psi, Behavioural Science Institute, Radboud University, The Netherlands; and Tarumanagara University, Jakarta, Indonesia
  • Direttore dello studio: Jan Spijker, Prof. dr., Behavioural Science Institute, Radboud University, The Netherlands, and Pro Persona Mental Health Care, Depression Expertise Centre, Nijmegen, the Netherlands
  • Direttore dello studio: Cilia Witteman, Prof. dr., Behavioural Science Institute, Radboud University, The Netherlands

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2017

Completamento primario (Effettivo)

1 novembre 2017

Completamento dello studio (Effettivo)

1 dicembre 2017

Date di iscrizione allo studio

Primo inviato

28 settembre 2016

Primo inviato che soddisfa i criteri di controllo qualità

3 novembre 2016

Primo Inserito (Stima)

8 novembre 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 marzo 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 marzo 2018

Ultimo verificato

1 settembre 2016

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • SAAQE-R053

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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