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Clinical Trials/CTRI/2024/06/068570
CTRI/2024/06/068570
Completed
Phase 2/3

Effect of Cold Mud Pack on Abdomen and Eyes on Acute Stress Reactivity, Perceived Stress and Sleep disturbance among Medical Students

Dr Nagachaithanya S1 site in 1 country60 target enrollmentStarted: July 1, 2024Last updated:

Overview

Phase
Phase 2/3
Status
Completed
Sponsor
Dr Nagachaithanya S
Enrollment
60
Locations
1
Primary Endpoint
1.Cold Pressor Test

Overview

Brief Summary

Clinically mud application in various forms is found benefited to relieve stress and reduce blood pressure in hypertensive individuals but there are no studies documented so far on the significant impact of cold mud application on abdomen and eyes. Hence this study is designed to hypothesize that there would be a significant difference in the acute stress response of the test group when the subjects have undergone cold pressor test which indicates that there was a decreased sympathetic arousal which represents cold mud pack may act on catecholaminergic activity in prefrontal cortex.

6.3.1 Objectives of the study

1.  To quantify the change in acute stress response for cold pressor test after CMPEA.

2.  To assess the effect of CMPEA on sleep quality and resilience among medical students.

Grouping :

Sixty Healthy individuals will be assessed at baseline and after 4 weeks of intervention by dividing into 2 groups with an equal number.

Test group: n = 30

Control group: n = 30

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 30.00 Year(s) (—)

Inclusion Criteria

  • Age: 18 – 30 years
  • Subjects who are willing to participate in the study.
  • Gender: Male and Female.

Exclusion Criteria

  • Medical Illness
  • Subjects with open wounds
  • Had caffeine 24 hours before.

Outcomes

Primary Outcomes

1.Cold Pressor Test

Time Frame: Baseline, 4 weeks post intervention

2.Blood Pressure

Time Frame: Baseline, 4 weeks post intervention

3.Galvanic Skin Response

Time Frame: Baseline, 4 weeks post intervention

Secondary Outcomes

  • Perceived Stress Scale (PSS-10)(Baseline, 4 weeks post intervention)

Investigators

Sponsor
Dr Nagachaithanya S
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Nagachaithanya S

SDM College of Naturopathy and Yogic Sciences

Study Sites (1)

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