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临床试验/NCT04079985
NCT04079985已完成不适用

Animal-assisted Intervention in Geriatric Patients With Chronic Joint Pain and Polypharmacy

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina0 个研究点目标入组 69 人开始时间: 2013年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
69
主要终点
Change from baseline Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index at 13 weeks

研究概览

简要总结

BACKGROUND: Nowadays, there is a progressive aging of population. Chronic osteoarticular pain is associated to a bigger consumption of medication and a deterioration of life quality in elderly people that could be improved by boosting education for health from Primary Health Care. JUSTIFICATION: The need to develop non pharmacological treatments in order to get better results in people's global care. PURPOSE: To evaluate the effectivity of group intervention, based on Animal Assisted Therapy, on elderly people suffering from chronic osteoarticular pain and poli-medication; regarding decrease of chronic pain, use of analgesics and improvement of life quality. MATERIAL AND METHOD: Randomized clinical trial, two arms, controlled and open-label. Twelve group sessions of kinesiotherapy with the intervention of a therapy dog in the experimental group (EG), carried out in the Primary Health Centre.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥65 years
  • diagnosis of chronic benign joint pain
  • polypharmacy (>5 drugs or active ingredients, of which 2 or more had been prescribed for pain)

排除标准

  • severe cognitive deterioration (GDS> 5)
  • allergy to or fear of animals

研究组 & 干预措施

Experimental Group

Experimental

The experimental Group underwent a therapeutic intervention based on sessions of kinesitherapy , which is defined as a set of "therapeutic procedures that use movement for the treatment and prevention of diseases of the locomotive apparatus". The experimental group also underwent AAT. We conducted a total of 12 weekly sessions of 60 minutes each with 10 participants.

干预措施: Animal-assisted therapy (Other)

Control Group

Active Comparator

The Control Group underwent a therapeutic intervention based on sessions of kinesitherapy , which is defined as a set of "therapeutic procedures that use movement for the treatment and prevention of diseases of the locomotive apparatus" without the presence of the therapy dog.

干预措施: Animal-assisted therapy (Other)

结局指标

主要结局

Change from baseline Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index at 13 weeks

时间窗: This questionnaire was administered at baseline and at week 13.

pain (0-20), stiffness (0-8), functional capacity (0-68)

次要结局

  • Change from baseline Lattinen test at 13 weeks(This questionnaire was administered at baseline and at week 13.)
  • Change from baseline EuroQoL Health Questionnaire at 13 weeks(This questionnaire was administered at baseline and at week 13.)
  • Change from baseline Visual Analog Scale at session 1(This questionnaire was administered at the baseline of session 1 and through session 1 completion, an average of 1 hour)
  • Change from baseline Visual Analog Scale at session 2(This questionnaire was administered at the baseline of session 2 and through session 2 completion, an average of 1 hour)
  • Change from baseline Visual Analog Scale at session 7(This questionnaire was administered at the baseline of session 7 and through session 7 completion, an average of 1 hour)
  • Change from baseline Visual Analog Scale at session 5(This questionnaire was administered at the baseline of session 5 and through session 5 completion, an average of 1 hour)
  • Change from baseline Visual Analog Scale at session 6(This questionnaire was administered at the baseline of session 6 and through session 6 completion, an average of 1 hour)
  • Change from baseline Visual Analog Scale at session 11(This questionnaire was administered at the baseline of session 11 and through session 11 completion, an average of 1 hour)
  • Change from baseline Visual Analog Scale at session 12(This questionnaire was administered at the baseline of session 12 and through session 12 completion, an average of 1 hour)
  • Change from baseline Visual Analog Scale at session 4(This questionnaire was administered at the baseline of session 4 and through session 4 completion, an average of 1 hour)
  • Change from baseline Visual Analog Scale at session 9(This questionnaire was administered at the baseline of session 9 and through session 9 completion, an average of 1 hour)
  • Change from baseline Health Assessment Questionnaire at 13 weeks(This questionnaire was administered at baseline and at week 13.)
  • Change from baseline Visual Analog Scale at session 3(This questionnaire was administered at the baseline of session 3 and through session 3 completion, an average of 1 hour)
  • Change from baseline Visual Analog Scale at session 8(This questionnaire was administered at the baseline of session 8 and through session 8 completion, an average of 1 hour)
  • Change from baseline Visual Analog Scale at session 10(This questionnaire was administered at the baseline of session 10 and through session 10 completion, an average of 1 hour)

研究者

发起方
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
申办方类型
Other
责任方
Sponsor

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