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临床试验/NCT03592147
NCT03592147已完成不适用

Identification of the Most Effective Relaxation Tool for Use in a Trial to Improve Breastfeeding Outcomes in Mothers of Late Preterm Infants: a Pilot Study

University College, London2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2018年4月13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
17
试验地点
2
主要终点
Blood Pressure

研究概览

简要总结

While the stress response, characterised by an increase in heart rate, blood pressure, and cortisol, has evolved to ensure the survival of the organism in face of danger, chronic stress due to psychological stressors can be harmful. The opposite of the stress response is the "relaxation response". Mind-body techniques such as meditation, guided imagery and music therapy are thought to induce this response. The relaxation response is characterized as a wakeful hypometabolic state, where a decrease in central nervous system arousal is observed. Some studies reported a reduction in stress hormones, and in symptoms of anxiety and depression following the use of mind-body relaxation techniques. Other studies noted a reduction in stress measured using physiological measurements such as heart rate and blood pressure.

Light therapy is another technique that is suggested to induce physiological changes similar to those seen in the relaxation response. Some studies have shown a reduction in heart rate, blood pressure, oxygen consumption and carbon dioxide production following exposure to blue light.

These relaxation therapies can be useful for the general population and for vulnerable groups where alternative therapies, such as medication and psychotherapy, are difficult. Limited amount of studies have quantified the decrease in stress in physiological measurements such as heart rate and blood pressure.

The aim of this study is to investigate which relaxation technique among five different interventions (and one control) is the most effective in improving relaxation and reducing stress in adult women of reproductive age (18-45 years). The results of this study will be used to inform the intervention of a study testing the impact of relaxation therapy on breastfeeding outcomes in mothers of late preterm infants.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women of reproductive age (18-45 years)
  • Fluent in English

排除标准

  • Any condition that may affect blood pressure, heart rate or energy expenditure i.e hypertension, hyperthyroidism, heart failure
  • Recent surgeries or injuries

结局指标

主要结局

Blood Pressure

时间窗: Post-intervention, an average of 10 mins

Systolic and diastolic blood pressure (mmHg) were measured three times using a digital sphygmomanometer.

Perceived Relaxation

时间窗: Post-intervention, an average of 10 mins

Perceived relaxation was assessed using a visual analogue scale (VAS), which is a 10 cm horizontal line spanning from the minimum to the maximum of the variable measured. The minimum (left) represents "completely unrelaxed" and the maximum (right) "completely relaxed". The women mark a point on the scale to indicate their feelings of relaxation. The distance between the mark and the minimum point was measured in centimetres (two decimal points).

Heart Rate

时间窗: Post-intervention, an average of 10 mins

Heart rate (bpm) was measured three times using a digital sphygmomanometer.

Fingertip Temperature

时间窗: Post-intervention, an average of 10 mins

A non-contact digital thermometer was used to measure fingertip temperature as an indication of sympathetic nervous system activation.

次要结局

  • Preference(At the end of the study, at approximately 3-6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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