Determine the Effect of the Fourth Ventricle Compression Technique on Heart Rate, Respiratory Rate, Blood Pressure, Thermal Variation and Skin Conductivity in Healthy Young Adults: a Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from Baseline in heart rate variability 15 minutes after the intervention
研究概览
简要总结
This study aims to analyze the influence of the fourth ventricle compression technique in heart rate, respiratory rate, blood pressure, conductivity and thermal variability of the skin in healthy young adults.
详细描述
The fourth ventricle compression technique (CV-4) is one of the most important techniques in the treatment of cranial osteopathy.
During the present study, the effects of CV-4 technique will be analyzed in the following variables: heart rate, respiratory rate, blood pressure, conductivity and thermal variation of the skin.
According to the literature, CV-4 technique will cause changes in all of the studied variables, except the respiratory rate, through the activation of the brain stem, namely the parasympathetic nerve centers.
Regarding the respiratory rate, it is justified by the fourth ventricle and the respiratory centers proximity.
Concerning heart rate and respiratory rate, during the CV-4 technique the literature describes a decrease in the values of this variables. However, other studies refer that the technique does not produce relevant effects in the heart and respiratory rates variation, probably because there was no stipulated time to finish the technique, ending subjectively compared to previous ones.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 33 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants aged between 18 and 33 years.
排除标准
- •Cognitive deficits that can possibly compromise the understanding of the study instructions;
- •Any type of medication taken that may have influences at the variables under study in the previous 7 days;
- •Cranio-cervical injuries, surgery to the skull and /or spine in the last 12 months;
- •Chronic cardiorespiratory, renal, systemic, neurological, musculoskeletal, oncological and psychiatric pathologies;
- •Headaches, migraines, dizziness and / or nausea while performing the techniques;
- •Caffeine and / or alcohol intake in the 6 hours prior to the data collection;
- •Tobacco consumption in the 30 minutes prior to the data collection;
- •Practice of intense physical exercise in the 90 minutes prior to the data collection;
- •Pregnant women or menstruating;
- •Participants who were submitted to manual therapy treatments during the past month;
- •Osteopathy students of 3rd year or higher degree, in order to prevent the participant from recognizing which group they belong to.
研究组 & 干预措施
CV-4 group
The initial selection will be made through a questionnaire, in order to fulfill the exclusion and inclusion criteria. On the data collection day a more detailed survey is performed and informed consent is signed.
The patient waits for 5 minutes in the supine position, after which the baseline evaluation is performed.
The CV-4 technique is performed following immediate evaluation. 15 minutes after the technique, a new evaluation of the variables is accomplished.
干预措施: Fourth ventricle compression technique (CV-4) (Other)
Control group
The initial selection will be made through a questionnaire, in order to fulfill the exclusion and inclusion criteria. On the data collection day a more detailed survey is performed and informed consent is signed.
The patient waits for 5 minutes in the supine position, after which the baseline evaluation is performed.
The sham technique is performed following immediate evaluation. 15 minutes after the technique, a new evaluation of the variables is accomplished.
干预措施: Sham (Other)
结局指标
主要结局
Change from Baseline in heart rate variability 15 minutes after the intervention
时间窗: 15 minutes after the intervention.
To obtain the heart rate measurements, a pulse volume sensor (Biosignalsplux researcher) was connected to the third finger of the hand, with the patient lying supine. The sensor was only removed after completing all the evaluation moments.
Change from Baseline in heart rate variability immediately after the intervention
时间窗: Immediately after the intervention.
To obtain the heart rate measurements, a pulse volume sensor (Biosignalsplux researcher) was connected to the third finger of the hand, with the patient lying supine. The sensor was only removed after completing all the evaluation moments.
次要结局
- Change from Baseline in blood pressure variability immediately after the intervention(Immediately after the intervention.)
- Change from Baseline in skin conductivity variability immediately after the intervention(Immediately after the intervention.)
- Change from Baseline in skin conductivity variability 15 minutes after the intervention(15 minutes after the intervention.)
- Change from Baseline in respiratory rate variability 15 minutes after the intervention(15 minutes after the intervention)
- Change from Baseline in blood pressure variability 15 minutes after the intervention(15 minutes after the intervention.)
- Change from Baseline in skin thermal variation immediately after the intervention(Immediately after the intervention.)
- Change from Baseline in skin thermal variation 15 minutes after the intervention(15 minutes after the intervention.)
- Change from Baseline in respiratory rate variability immediately after the intervention(Immediately after the intervention.)
研究者
Natália Maria Oliveira Campelo
Professor
Escola Superior de Tecnologia da Saúde do Porto