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临床试验/NCT05771649
NCT05771649已完成不适用

Differential Effectiveness of Two Recovery Strategies, Based on Mindfulness and Physical Exercise, on Levels of Stress, Academic Performance, and Inmunoglobulin A. A Controlled Trial. A, and Cortisol. A Randomized Controlled Trial

Universidad Nacional de Educación a Distancia2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年3月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
2
主要终点
Change in Salivary Immunoglobulin A (SIgA) with four time points data.

研究概览

简要总结

The present study aims to compare the differential effects of mindfulness meditation (MBI) and physical exercise (PE) on different stress, academic performance and health variables (self-report means and biological measure of IgA levels). A controlled trial of three groups is proposed, with pretest, posttest and two follow-ups at 1 and 3 months that would be developed among the Guardia Civil (Spanish military police) non-commissioned officers and officers academies.

详细描述

Recovery from fatigue and daily stress involves mentally disconnecting from the journal. To achieve this disconnection (or psychological detachment), research has shown that engaging in a variety of interesting and motivating activities for individuals after the day allows them to achieve this disconnected state of mind and, consequently, facilitates recovery from work.

Previous research has shown that two of the most effective recovery activities are physical exercise (PE) and mindfulness meditation (MBI), although the results on the differential effects of the two are not conclusive (Karabinski et al, 2021; Steed et al., 2021; Wendsche et al., 2021).

Thus, the present study aims to compare the differential effects of MBI and PE on different stress, academic performance and health variables (self-report means and biological measure of IgA salivary levels). A non-randomized controlled trial (participant chooses to take of three groups proposed) with pretest, posttest and two follow-ups at 1 and 3 months. It would be developed among the Guardia Civil (Spanish military police) non-commissioned officers and officers academies (N ≥ 150). An MBI (focused attention meditations), an aerobic PE program (running with mental association strategies) and an inactive control / waiting list (LE) condition will be contrasted.

The dependent variables considered are: 1) recovery experiences; 2) perceived stress; 3) general health; 4) academic performance; 5) positive and negative affect; 7) daily states of fatigue, stress, psychological distancing, mindfulness, and sleep; 8) IgA levels in saliva. The intervention program is structured for four weeks, during which the two intervention groups will carry out their recovery strategy (MBI or PE), starting and increasing the practice 5 minutes every two weeks. The control group will continue as usual. The investigators believe that this study is a quasi-pioneering initiative because of its theme, and will have an important scientific and technical impact. The importance of the topic addressed in terms of health and academic performance is associated with important contributions in terms of knowledge transfer to the educational field and society in general.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Blinding of trial participants and care providers is not possible because of obvious differences between the interventions.

入排标准

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

入选标准

  • Age from 18 to 65 years.

排除标准

  • Currently practicing any type of meditation regularly.
  • To have a physical or mental illness that prevents mindfulness practice.
  • To take medication that interferes with salivary inmunoglobulin A (SIgA).

结局指标

主要结局

Change in Salivary Immunoglobulin A (SIgA) with four time points data.

时间窗: Baseline (1 week before interventions), Pre-treatment (the day the interventions start), Post-treatment (4 weeks from the start of the interventions), 1-month follow-up

Biological measures. Salivary IgA levels as a biomarker of mucosal immunity.

Change in stress with four time points data.

时间窗: Pre-treatment (the day the interventions start), Post-treatment (4 weeks from the start of the interventions), 1-month follow-up, 3-month follow-up

A single item was used: Stress refers to a person's situation when they feel tense, restless, nervous, or anxious, or are unable to sleep at night because their mind is constantly preoccupied with work-related issues. Please indicate the extent to which you currently feel this type of stress. It has five possible responses on a Likert-type scale from 1 to 5 (being 1 nothing and 5 a lot), with higher scores indicating higher perceived stress

Change in General Health with four time points data.

时间窗: Pre-treatment (the day the interventions start), Post-treatment (4 weeks from the start of the interventions), 1-month follow-up, 3-month follow-up

The General Health Questionnaire (GHQ-12) consists of 12 items. It is a unidimensional measure of psychological distress. It is answered on a Likert-type scale from 1 to 4 (1 = Never and 4 = Always). The score was used to generate a total score ranging from 0 to 36. Total scores range from 0 to 36 with a score of 11 or 12 considered typical, scores \> 15 suggesting evidence of distress, and scores \> 20 are considered severe problems with psychological distress.

Change in Need for Recovery with four time points data.

时间窗: Pre-treatment (the day the interventions start), Post-treatment (4 weeks from the start of the interventions), 1-month follow-up, 3-month follow-up

The Need for Recovery (NFR) Scale consists of 9 items. It facilitates the understanding of the factors that can lead to sustainable working and employability. It is answered on a Likert-type scale from 1 to 5 (1 = Never and 5 = Always). The score was used to generate a total score ranging from 1 to 100.Our research team will carry the validation of the Spanish version of NFR. The higher the score, the higher the fatigue symptoms presented by the worker.

Change in Academic Performance with four time points data.

时间窗: Pre-treatment (grades before the interventions start), 1 and 3-month follow-up (grades after the interventions finish)

Academic performance will be measured directly through the grades obtained in the academy (by course and by subject).

Change in Positive and Negative Affect with four time points data.

时间窗: Pre-treatment (the day the interventions start), Post-treatment (4 weeks from the start of the interventions), 1-month follow-up, 3-month follow-up

The PANAS Scales of Positive and Negative Affect (PANAS) - Spanish version has 20 items. It is the most widely used scale of affectivity. It has two dominant dimensions, positive affect (10 items) and negative affect (10 items) It is answered on a Likert-type scale from 1 to 5 (1 = Very slightly or Not at all and 5 = Extremely). The score was used to generate a total score ranging from 20 to 100. For the total positive score, a higher score indicates more of a positive affect. For the total negative score, a lower score indicates less of a negative affect.

次要结局

  • Change in Sleep (item n. 6 from the Pittsburg Sleep Quality Index).(Time Frame: 4 days per week during the 4-week interventions)
  • Change in Psychological distancing (item n. 3 from the Recovery Experience Questionnaire).(Time Frame: 4 days per week during the 4-week interventions)
  • Change in Stress (single-item measure from the Single-item Measure of Stress Symptoms).(Time Frame: 4 days per week during the 4-week interventions)
  • Change in Fatigue (single-item measure from the Single-Item Fatigue Measure)(Time Frame: 4 days per week during the 4-week interventions)
  • Change in Mindfulness (item n. 3 from the Five Facets Mindfulness Questionnaire).(Time Frame: 4 days per week during the 4-week interventions)

研究者

发起方
Universidad Nacional de Educación a Distancia
申办方类型
Other
责任方
Sponsor

研究点 (2)

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