Effects of Left Nostril Breathing in Young Females Having Cardiovascular Hyper Reactivity to Cold Pressor Test.

The purpose of this study is to evaluate the effects of left nostril breathing in young females having cardiovascular hyper reactivity to cold pressor test.Although,limited literature exist regarding hyper reactivity towards stress induced test in our youth and its effective and easy treatment in the form of left nostril breathing which could proves to be beneficial for our youth.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Left Nostril Breathing; Other: Conventional

Detailed Description

The Cold Pressor Test (CPT) was introduced as a standard incentive for studying the vasomotor response (Hines and Brown 1932). Hyper-reactors were the subjects in his study who responded more strongly to CPT, Participants who show hyper reactivity to Cold pressor test (i.e. subjects showing 25 mmHg increase in systolic blood pressure along with 20 mmHg increase in diastolic blood pressure).They proposed that these hyper reactive could be candidates for hypertension in the future. Increased occurrence of these diseases could be attributed to an asymmetry in sympathetic and parasympathetic stimulation. Control or adaptation of breathing or breathing workouts i-e yoga are thought to be beneficial in the treatment of such disease. Although Yoga techniques proven to be effective in treating stress related disorders but it is time consuming and young population because of their busy routine couldn't be able to take out time for their health related issues. This study introduces very simple exercise in the form of left nostril breathing which decreases sympathetic activity and increases parasympathetic activity. It is inversely proportional to stress induced response of the body, it is very easy to perform and can be done at any time, and if found significantly effective for stress disorder ,it could be used in daily routine by our youth to get themselves prevented from major risk factors of CVD's particularly hypertension. This study will identify participants with a high potential risk of developing hypertension in the future by administering Cold pressor test, additionally the effects of left nostril breathing intervention on hyper reactive participants would be observed and if found significant, it would be a major breakthrough in primary prevention of hypertension.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • KPK
    • Abbottābād, KPK, Pakistan, 22010
      • Women Instritute of Rehabilitation Sciences, Jinnah College of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants falling in the following category would be recruited into the study:
• Females Age (18-25) years
• Participants who show hyper reactivity to Cold pressor test (i.e subjects showing 25mmHg increase in systolic blood pressure along with 20mmHg increase in diastolic blood pressure)
• Consenting participants.

Exclusion Criteria:

• The participants in the following category would be excluded from the study:
• Participants on antihypertensive drugs.
• Participants who are diagnosed with any cardiovascular, renal, hepatic or metabolic disease.
• Participants having malignant tumor.
• Participants with nasal blockages, polyps ,Raynaud phenomena
• Females during menstrual cycle, pregnancy or on oral contraceptives.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Left Nostril Breathing; The intervention protocol include healthy young females age 18-25 years.. All baseline measurements will be taken , Afterwards, the Cold pressor test would be performed for 1 minutes to induce acute stress while the BP would be monitored for every 30 seconds. At the end of the test, again the BP would be monitored. Out of all the recordings, the BP measuring the highest value would be recorded as final. We will then subtract the normal resting BP by highest value of the recording for each participant. Change in BP of systolic by 25mmHg and diastolic by 20mmHg will be considered hyper reactive. Then the hyper reactive subjects will be divided into two groups. Experimental group will receive left nostril breathing. CPT will be performed again at 4, 8 and 12 weeks to monitor the BP, heart rate and Spo2 likewise to check for any decline in sympathetic activity.	Other: Left Nostril Breathing; The participants which will show cardiovascular hyper reactivity towards CPT will be divided into 2 groups having 30 participants in each group. Experimental group will receive Left Nostril Breathing(slow, deep breath taken through your left nostril while closing your right nostril with your right thumb. Then just as gently exhale long, slowly, and completely through the left nostril, just as gently. It will be done while sitting) for 10 minutes twice a day for the duration of 12 weeks. Follow up will be taken through administration Cold pressor test after every 4,8 and 12 weeks.
Active Comparator: Conventional; The conventional protocol include healthy young females age 18-25 years. All baseline measurements will be taken, Afterwards, the Cold pressor test would be performed for 1 minutes to induce acute stress while the BP would be monitored for every 30 seconds. At the end of the test, again the BP would be monitored. Out of all the recordings, the BP measuring the highest value would be recorded as final. We will then subtract the normal resting BP by highest value of the recording for each participant. Change in BP of systolic by 25mmHg and diastolic by 20mmHg will be considered hyper reactive. Then the hyper reactive subjects will be divided into two groups Group A(Experimental) and Group B(Conventional). Controlled group will receive simple deep breathing exercises ,3 sessions per week for 12 weeks. CPT will be performed again at 4, 8 and 12 weeks to monitor the BP, heart rate and Spo2 likewise to check for any decline in sympathetic activity.	Other: Conventional; 30 participants will be recruited in conventional group which will receive simple deep breathing exercises of 3 sessions per week for the duration of 12 weeks.Follow up will be taken after every 4,8 and 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cold pressor test	Cold pressor test will be conducted on participants to measure cardio vascular hyper reactivity to stress induce test.	After 4 weeks
Blood pressure	Mercury sphygmomanometer will be used to measure blood pressure of participants	After 4 weeks
Heart Rate	Pulse oximeter will be applied to the participant to measure their Heart rate.	After 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen saturation	Pulse oximeter will be used on participant to measure Spo2.	after 4 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Suman Sheraz, PhD*, Riphah International University

Publications and helpful links

General Publications

• Shah N, Shah Q, Shah AJ. The burden and high prevalence of hypertension in Pakistani adolescents: a meta-analysis of the published studies. Arch Public Health. 2018 Apr 2;76:20. doi: 10.1186/s13690-018-0265-5. eCollection 2018.
• Malhotra V, Srivastava R, Parasuraman P, Javed D, Wakode S, Thakare A, Sampath A, Kumari A. Immediate autonomic changes during right nostril breathing and left nostril breathing in regular yoga practitioners. J Educ Health Promot. 2022 Aug 25;11:280. doi: 10.4103/jehp.jehp_343_22. eCollection 2022.
• Jain N, Srivastava RD, Singhal A. The effects of right and left nostril breathing on cardiorespiratory and autonomic parameters. Indian J Physiol Pharmacol. 2005 Oct-Dec;49(4):469-74.
• Bargal S, Nalgirkar V, Patil A, Langade D. Evaluation of the Effect of Left Nostril Breathing on Cardiorespiratory Parameters and Reaction Time in Young Healthy Individuals. Cureus. 2022 Feb 18;14(2):e22351. doi: 10.7759/cureus.22351. eCollection 2022 Feb.
• Wood DL, Sheps SG, Elveback LR, Schirger A. Cold pressor test as a predictor of hypertension. Hypertension. 1984 May-Jun;6(3):301-6. doi: 10.1161/01.hyp.6.3.301.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: May 17, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 28, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: blood pressure; heart rate; cold pressor test
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: Muqaddas Bibi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No