NCT05876637

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

May 17, 2023

Last Update Submit

January 28, 2024

Conditions

Keywords

blood pressurecold pressor testheart rate

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Oxygen saturation

    after 4 weeks

Study Arms (2)

Left Nostril Breathing

EXPERIMENTAL

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

Conventional

ACTIVE COMPARATOR

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

Interventions

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.

Left Nostril Breathing

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.

Conventional

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women Instritute of Rehabilitation Sciences, Jinnah College of Nursing

Abbottābād, KPK, 22010, Pakistan

Location

Related Publications (5)

  • 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.

    PMID: 29619218BACKGROUND
  • 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.

    PMID: 36325230BACKGROUND
  • 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.

    PMID: 16579402BACKGROUND
  • 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.

    PMID: 35371755BACKGROUND
  • 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.

    PMID: 6735451BACKGROUND

MeSH Terms

Interventions

Congresses as Topic

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Suman Sheraz, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2023

First Posted

May 25, 2023

Study Start

September 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 15, 2023

Last Updated

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations