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临床试验/NCT03266120
NCT03266120已完成不适用

Assessing Human Health Benefits of Gardening

University of Florida4 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2017年8月3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
入组人数
36
试验地点
4
主要终点
Biometric Changes in Heart Rate

研究概览

简要总结

The objective of the research is to test the hypothesis that participating in group-based gardening or group-based art activities may alter the mental health and cardiac physiological status of a wellness population of women ages 26-49. Assessment of the effects of gardening or art activities on the experimental population will take two approaches, the first being the use of physiological measurements of heart rate and blood pressure. The second approach will employ six widely used and well-established self-reported assessment instruments that will capture information about the health and well-being of participants. These measurements and assessments will provide a psychometrically-based before and after mental health status and between treatments health summaries of the participants in the gardening group and those engaged in the art group activities.

详细描述

The goal of this project is to better understand how interacting and working with plants in a group gardening activities program in a greenhouse, or a group art program that takes place indoors and is devoid of images or depictions of plants influences the overall health and well-being of participants.

A total anticipated study population (N = 40) will consist of up to 20 healthy women randomly assigned to the art activities group, and up to 20 healthy women assigned to the gardening group. There will be measurements of heart rate, systolic and diastolic blood pressure, and psychometric assessments including satisfaction of social activities at baseline and post intervention. Heart rate and blood pressure measurements will be taken at the beginning and end of each of the eight gardening or arts sessions. Psychometric assessments of study participants will be conducted at baseline and post-intervention. Each treatment group will be divided into two smaller groups of up to ten women each that will receive the gardening or art interventions on different days of the week. The participants in the gardening or art groups will receive an experimental intervention consisting of 8 gardening or art sessions, each approximately 60 minutes in duration over a four week treatment period. Gardening and art sessions will take place at the same time of day twice each week, and follow a standardized programming sequence to ensure equivalency of intervention across all sessions. Ambient environmental conditions in the greenhouse during the gardening sessions will be monitored and recorded. The gardening activities will emphasize growing plants from seeds, plant propagation techniques, transplanting, and plant-mediated taste, visual, olfactory and touch sensory stimulation. All gardening sessions will begin with a short educational module introducing the plants and gardening activities taking place during each session. Art activities will include papermaking, image transfer, visual storytelling, linocut printmaking, paper batik, mixed media collage, and sensation drawing, and begin with a short educational module of the activity.

In addition to the pre- and post-intervention assessments and measurement, psychometric assessments will be administered for depression symptomatology, mood states and perceived stress at specific points during the gardening and art activities to evaluate any changes over time resulting from the interventions. Participant heart rate and blood pressure measurements will be made at the beginning and at the end of all gardening and art sessions.

研究设计

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

入排标准

年龄范围
26 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Premenopausal women
  • 26 - 49 years of age
  • Not pregnant
  • Non-gardener
  • Non-artist
  • Non-smoker
  • Good Health
  • Able to participate in all aspects of the study, including working with plants.

排除标准

  • Uncomfortable in close spaces (claustrophobia)
  • Allergies to plants
  • Allergies to plant parts like pollen
  • Allergies to plant-based foods
  • No additions to alcohol or to recreational drugs or prescription medications
  • Not suffering from recurring pain, and
  • No diseases, disorders or disabilities that affect daily life.

研究组 & 干预措施

Art Intervention

Active Comparator

Participants randomly assigned to this arm will receive a hands-on art intervention that will consist of twice weekly group sessions of approximately 60 minutes each in duration that will take place indoors over a period of four weeks for a total of eight art sessions. Participants will complete sets of self-report psychometric assessments and blood pressure and heart rate will be monitored before, during, and following the conclusion of the intervention.

干预措施: Art (Other)

Gardening Intervention

Experimental

Participants randomly assigned to this arm will receive a hands-on gardening intervention that will consist of twice weekly group sessions of approximately 60 minutes each in duration that will take place in a greenhouse over a period of four weeks for a total of eight gardening sessions. Participants will complete sets of self-report psychometric assessments and blood pressure and heart rate will be monitored before, during, and following the conclusion of the intervention.

干预措施: Gardening (Other)

结局指标

主要结局

Biometric Changes in Heart Rate

时间窗: Baseline, up to 5 weeks

Heart rate will be monitored using a portable electronic wrist cuff monitor. Participant heart rate will be measured at the beginning and end of each Individual treatment session, and before the beginning and after the completion of the entire treatment interventions.

Biometric Changes in Blood Pressure

时间窗: Baseline, up to 5 weeks

Blood pressure will be monitored using a portable electronic wrist cuff blood pressure monitor that records systolic and diastolic pressure. Participant blood pressure measurements will be recorded before and after each individual treatment session, and before the beginning and after the completion of the entire treatment interventions.

次要结局

  • Biometric Changes in Overall Health Status(Baseline, up to 5 weeks)
  • Biometric Changes in Depressive Symptomatology(Baseline, up to 5 weeks)
  • Biometric Changes in State Anxiety(Baseline, up to 5 weeks)
  • Biometric Changes in Mood States(Baseline, up to 5 weeks)
  • Biometric Changes in Perceived Stress(Baseline, up to 5 weeks)
  • Biometric Changes in Satisfaction in Social Activities(Baseline, up to 5 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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