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临床试验/NCT05486156
NCT05486156已完成不适用

Evaluation of the Effectiveness of a Multicomponent Nature-based Intervention for Well-being and Relationship With Nature in Different Natural Areas: a Randomized Clinical Trial

Hospital Israelita Albert Einstein12 个研究点 分布在 1 个国家目标入组 486 人开始时间: 2022年10月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
486
试验地点
12
主要终点
Change from baseline Well-Being Index at 30 days follow-up.

研究概览

简要总结

Randomized clinical trial to evaluate the efficacy of a multi-component nature-based intervention on clinical outcomes for visitors from different natural areas in Brazil.

详细描述

There is a growing scientific literature that indicates a series of benefits of contact/connection with nature for health and well-being, such as the mental health improvement, hypertension improvement, restoration of attention and memory and immune system improvement. It is already known, among other findings, that contact with nature, even indirectly, through videos and photos, can promote a greater sense of relaxation, decrease stress levels and can promote positive emotions. The adoption of nature-based interventions has been expanded, both for the prevention of chronic health conditions and the promotion of general well-being, as well as for the treatment of physical, mental and social health.

This clinical trial aims to assess the mean change in the World Health Organization well-being index, changes in self-perception of happiness, vitality, connection and engagement with nature in the pre-intervention, post-intervention and 30-day follow-up moments, in the control and intervention groups, in six different natural areas. In the multicomponent intervention, in addition to including walking in nature with attention to the senses, which will be carried out by the control group, the investigators associate other elements of a cognitive-behavioral nature, aiming human and non-human well-being. Therefore, in this health nature-based intervention, activities related to four types of experience are proposed (1- knowledge; 2- aesthetic/emotional; 3- integrated multisensory, 4- active experience). The study hypothesis is that Well-being, happiness and vitality outcomes will be more positive in the intervention group, and the connection with nature and engagement with conservation at 30 days post-intervention will be greater in the intervention group as well, due to adherence to nature-related activities that will be monitored and knowledge offered

研究设计

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

盲法说明

In this study data analysts were blinded.

入排标准

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

入选标准

  • Voluntary participation;
  • Signed in the Informed Consent Form (able to understand and agree to participate in the study)
  • Have conditions of digital access to the link of the study questionnaires, which will be provided by the team.

排除标准

  • Display walking difficulties;
  • Participants with phobia related to elements of nature;
  • History of allergies when in contact with nature.

结局指标

主要结局

Change from baseline Well-Being Index at 30 days follow-up.

时间窗: immediately pre and immediately post intervention and within 4 weeks post intervention

The World Health Organization-5 Well-Being Index is a brief scale, composed of five questions in which the participants indicate in each one of them, based on the last two weeks, the frequency of their sensations, being 0 (at no time) and 5 (all of the time). The result is given as the sum of the numbers of each statement, with values ranging from 0, which represents the worst possible quality of life and 25, which is associated with the best possible quality of life.

次要结局

  • Change from baseline nature engagement at 30 days after intervention(Immediately Pre intervention and within 4 weeks post intervention)
  • Change from baseline vitality at immediate post-intervention and 30 days follow-up.(immediately pre and immediately post intervention and within 4 weeks post intervention)
  • Change of Connection with Nature from baseline to 30 days post-intervention(Immediately Pre intervention and within 4 weeks post intervention)
  • Change from baseline self-perception of happiness at immediate post-intervention and 30 days follow-up.(immediately pre and immediately post intervention and within 4 weeks post intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (12)

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