Effectiveness of Volume Spirometry and Deep Breathing Exercise for Dyspnea During Third Trimester of Pregnancy

NCT ID: NCT04994028

Last Updated: 2021-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-13
• Study Completion Date: 2021-07-15

Brief Summary

During pregnancy women undergoes anatomical, mechanical and physiological changes to meet the demand of growing fetus. Dyspnea is a common complaint in pregnancy related to change in respiratory centre threshold and sensitivity. Pregnant women who engaged in regular exercise have less pregnancy induced discomforts like dyspnea and leg cramps than who did not engage in exercise. During pregnancy women undergoes anatomical, mechanical and physiological changes to meet the demand of growing fetus. Purpose of this study was to evaluate the efficacy of volume Spirometry and breathing exercise on dyspnea in third trimester of pregnancy. Rationale of the study was to find the effects of volume Spirometry and breathing exercise on dyspnea with focus on method of deep breathing exercise and volume Spirometry and outcomes. Significance of this study was to improve functional capacity and quality of life in pregnancy induced dyspnea. Subjects were randomly allocated to either two groups both groups received baseline treatment while interventional group received volume Spirometry and deep breathing exercise. Estimated sample size of 48 divided into 24 in either group by randomization. Modified Borg scale and visual analog scale were used to collect the findings. Non-parametric tests were used and analyzed by using spss22.

Conditions

Dyspnea; Pregnancy Related

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Conventional treatment

Conventional treatment that include behavioral and life style modification and dyspnea prevention education

Group Type: ACTIVE_COMPARATOR

Conventional treatment

Intervention Type: OTHER

Behavioral and life style modification and dyspnea prevention education i.e. Sitting: Sit upright with back against chair, feet wide apart, leaning forward with arms on bedside table or on knees. Standing: Lean back against wall with feet slightly apart with head and shoulder relaxed. In Bed: Elevate head of the bed, support and elevate arms with pillow. Stairs: Lean forward with on banister when climbing stairs.

conventional treatment with volume Spirometry and deep breathing

Conventional treatment along with volume Spirometry and deep breathing exercise

Group Type: EXPERIMENTAL

conventional treatment with volume Spirometry and deep breathing

Intervention Type: OTHER

Group B or interventional group was received conventional treatment along with volume Spirometry and deep breathing exercise, total 5 breaths with 3sec inhalational breath hold for each breath at one session per day for volume Spirometry and for deep breathing exercise 10 times with breath hold 2sec at every session for 5 minutes 3 times per week for total duration of two weeks.

Interventions

Conventional treatment

Behavioral and life style modification and dyspnea prevention education i.e. Sitting: Sit upright with back against chair, feet wide apart, leaning forward with arms on bedside table or on knees. Standing: Lean back against wall with feet slightly apart with head and shoulder relaxed. In Bed: Elevate head of the bed, support and elevate arms with pillow. Stairs: Lean forward with on banister when climbing stairs.

Intervention Type: OTHER

conventional treatment with volume Spirometry and deep breathing

Group B or interventional group was received conventional treatment along with volume Spirometry and deep breathing exercise, total 5 breaths with 3sec inhalational breath hold for each breath at one session per day for volume Spirometry and for deep breathing exercise 10 times with breath hold 2sec at every session for 5 minutes 3 times per week for total duration of two weeks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• BMI 18.5-30
• Primigravida and multigravida with 3rd trimester
• Singleton and twin pregnancy

Exclusion Criteria

• Cardiac and respiratory disorders
• Smoker
• Obesity
• Any type of allergy
• Autoimmune disorders

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fareeha Kausar, PP-DPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

DHQ Teaching Hospital

Dera Ghazi Khan, Punjab Province, Pakistan

Countries

Pakistan

References

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Reference Type: BACKGROUND

PMID: 31130705 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 19450766 (View on PubMed)

Bidad K, Heidarnazhad H, Pourpak Z, Ramazanzadeh F, Zendehdel N, Moin M. Frequency of asthma as the cause of dyspnea in pregnancy. Int J Gynaecol Obstet. 2010 Nov;111(2):140-3. doi: 10.1016/j.ijgo.2010.05.024. Epub 2010 Aug 12.

Reference Type: BACKGROUND

PMID: 20708180 (View on PubMed)

Chiron B, Laffon M, Ferrandiere M, Pittet JF, Marret H, Mercier C. Standard preoxygenation technique versus two rapid techniques in pregnant patients. Int J Obstet Anesth. 2004 Jan;13(1):11-4. doi: 10.1016/S0959-289X(03)00095-5.

Reference Type: BACKGROUND

PMID: 15321433 (View on PubMed)

Nurcahyani AS, Runjati R, Nugraheni SA. Giving Belly Breathing Technique and Positive Affirmation of Stress and Cortisol Hormone Levels in Third Trimester Pregnant Women. 2020. 77. Fiskin G, Sahin NH. Effect of diaphragmatic breathing exercise on psychological parameters in gestational diabetes: A randomised controlled trial. European Journal of Integrative Medicine. 2018;23:50-6

Reference Type: BACKGROUND

Armstrong CO. Post-op incentive spirometry: Why, when, & how. Nursing. 2017 Jun;47(6):54-57. doi: 10.1097/01.NURSE.0000516223.16649.02. No abstract available.

Reference Type: BACKGROUND

PMID: 28538354 (View on PubMed)

Other Identifiers

REC/Lhr/20/0301 Uzma Batool

Identifier Type: -

Identifier Source: org_study_id