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

• Sponsor: Riphah International University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05876637
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 6.5
• Patients Per Site Per Month: 9.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Left Nostril Breathing; Other: Conventional	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Effects of Left Nostril Breathing in Young Females Having Cardiovascular Hyper Reactivity to Cold Pressor Test.
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Nov 15, 2023
• Anticipated Study Completion Date: Dec 15, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Cold pressor test [After 4 weeks]

   Cold pressor test will be conducted on participants to measure cardio vascular hyper reactivity to stress induce test.

2. Blood pressure [After 4 weeks]

   Mercury sphygmomanometer will be used to measure blood pressure of participants

3. Heart Rate [After 4 weeks]

   Pulse oximeter will be applied to the participant to measure their Heart rate.

Secondary Outcome Measures

1. Oxygen saturation [after 4 weeks]

   Pulse oximeter will be used on participant to measure Spo2.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 25 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Women Instritute of Rehabilitation Sciences, Jinnah College of Nursing	Abbottābād	KPK	Pakistan	22010

Sponsors and Collaborators

• Riphah International University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Riphah International University
• ClinicalTrials.gov Identifier: NCT05876637
• Other Study ID Numbers: Muqaddas Bibi
• First Posted: May 25, 2023
• Last Update Posted: May 31, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Riphah International University: blood pressure; cold pressor test; heart rate
• Additional relevant MeSH terms: Respiratory Aspiration

Study Results

No Results Posted as of May 31, 2023