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临床试验/CTRI/2023/05/053149
CTRI/2023/05/053149尚未招募2/3 期

Effect of warm foot bath with ice massage to head and spine on Autonomic variables in healthy individuals

Dr pavan K S1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年1月6日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
1. Blood pressure

研究概览

简要总结

Inhydrotherapy, baths are one of the ways to apply water to the human body fortherapeutic purposes. Baths can be a full or partial immersion of the body inthe water of different temperatures. Since ancient times,thermoneutral, warm and hot temperatures (33.5°C - 41°C) have been widely usedfor foot baths.

Inhydrotherapy, ice is a therapeutic agent used in medicine as an integral partof injury treatment and rehabilitation. The application of ice has been shown to producephysiological changes. Ice massage is performed by means of a rubber bag filledwith ice or ice water to the head and spine for durations of 15 to 20 minutes. It is a simple and inexpensive procedure, and a studycomparing three types of cold simulations (ice application to hands, forehead,and face) and their effects on cardiovascular adaptations (E.g., application ofice to sites other than the hands, including the forehead and face), BloodPressure (BP) and Heart Rate (HR),(16) were reduced, with a significant improvement in Heart Rate Variability(HRV) toward vagal dominance. The ice pack or intense, prolonged cold applications to theback have a sedative effect on the spinal cord and also on the vasomotorsympathetic nerve centers.

There are fewstudies on ice massage to the head and spine alone on blood pressure and HRV onwarm foot bath as a single treatment in different groups, but no studies on thecombination of both treatments.

Becauseindividual treatments have their own benefits, they usually result in greatereffects when combined. The present study aimed to investigate the effect ofwarm foot bath with ice massage to the head and spine on autonomic variables inhealthy individuals.

Grouping:

Subjects will be divided into threegroups by computer generated randomization:

·      Group 1: Warm foot bath with ice massage to head and spinefor 20 minutes (n ≥ 30).

·      Group 2: Warm foot bath for 20 minutes (n ≥30).

·      Group 3:Ice massage to head and spine for 20minutes (n ≥ 30)

Method:

·      Institutional ethical clearancewill be obtained prior to the conduct of the study.

·      Informed consent will be obtainedfrom the individuals by explaining the study objectives, methods, interventionand will be obtained from every participant after an appraisal about the studyprotocol.

·      All the rights of the individualpertaining to the study in their own language.

·      After selecting the eligiblesubjects.

·      Allotment will be done by using aComputer-generated random number.

·      Group 1: Warm foot bath with ice massage tohead and spine for 20 minutes (n  30).

·      Group 2: Warm foot bath for 20 minutes (n ≥ 30).

·      Group 3: Ice massage to head and spine for 20 minutes (n ≥30).

·      Assessments will be done before andafter the intervention (Fig. 1).

·  Data collected will be tabulatedand analyzed using appropriate statistical methods.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 25.00 Year(s)(—)
性别
All

入选标准

  • Subjects willing to participate in the study.

排除标准

  • Subjects with systemic or mental illness.
  • Subjects with regular use of medication.
  • Subjects with open wounds.
  • Weak and debilitated subjects.
  • Females during menstruation.
  • Subjects who consume alcohol and nicotine.

结局指标

主要结局

1. Blood pressure

时间窗: Baseline and 5 minutes post intervention

2. Heart rate variability

时间窗: Baseline and 5 minutes post intervention

次要结局

  • Digital pulse propagation index(Baseline and 5 minutes post intervention)

研究者

发起方
Dr pavan K S
申办方类型
Other [self]

研究点 (1)

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