- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05474508
Effects of Diaphragmatic Breathing With and Without Aerobic Exercise on Stress, Fatigue and Sleep Quality
Effects of Diaphragmatic Breathing With and Without Aerobic Exercise on Stress, Fatigue and Sleep Quality Among Post Postpartum Women
The puerperium is a critical phase for women , not only does it have a significant impact on the mental and physical health of fresh mothers, but it can also be one of the most stressful moments in a woman's life .Serious psycho- social problems, including fatigue, depression, and stress, have been reported that occurred during the postpartum period. Diaphragm breathing method (DBE).DBE, also known as Diaphragmatic Breathing or Deep Breathing, is an effective holistic mind body workout for coping with stress and physical and mental conditions.Postpartum fatigue is considered the foremost common issue that postnatal ladies stand up to when they move to motherhood.postpartum fatigue is described as sentiments of fatigue,suffocation and diminishes in physical and mental capacity.
This study will be a randomized clinical trial. Sample will be collected through convenient sampling technique.Randomization will be done through lottery method and patients will be divided into two groups. Group A will receive both aerobic exercises and diaphragmatic breathing exercise. B will receive only diaphragmatic breathing exercise. Data will be collected before and after treatment .data will be analyzed through SPPS 25.
Study Overview
Status
Intervention / Treatment
Detailed Description
The puerperium is a critical phase for women , not only does it have a significant impact on the mental and physical health of fresh mothers, but it can also be one of the most stressful moments in a woman's life .Serious psycho- social problems, including fatigue, depression, and stress, have been reported that occurred during the postpartum period. As a result, postpartum psychological problems can affect the new mother's ability to care for children and affect her quality of life. Sleep problems, such as poor sleep quality and sleep disturbance, often occur in perinatal and postnatal women.Studies have shown that non- pharmacological interventions for postoperative pain reduce pain intensity. One of these non-pharmacological methods is the diaphragm breathing method (DBE).DBE, also known as Diaphragmatic Breathing or Deep Breathing, is an effective holistic mind body workout for coping with stress and physical and mental conditions.Postpartum fatigue is considered the foremost common issue that postnatal ladies stand up to when they move to motherhood.postpartum fatigue is described as sentiments of fatigue,suffocation and diminishes in physical and mental capacity.
This study will be a randomized clinical trial. Sample will be collected through convenient sampling technique.Randomization will be done through lottery method and patients will be divided into two groups. Group A will receive both aerobic exercises and diaphragmatic breathing exercise. Exercise programs will consist of 1 set of contractions per day and each set will include 30 repetitions for 6 weeks. Exercise protocol consist of at least 150 minutes of moderate-intensity aerobic activity every week dividing the 150 minutes into 30-minute workouts on 5 days of the week or into smaller 10-minute sessions throughout each day will be carried out for 6 weeks.Group B will receive only diaphragmatic breathing exercise. Exercise programs will consist of 1 set of contractions per day and each set will include 30 repetitions for 6 weeks. Data will be collected before and after treatment .data will be analyzed through SPPS 25.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Jinnah Hospital, gynae ward
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women with age group of 20- 40 were included in study.
- Women who had Vaginal or c section delivery were included in study.
- Women with no postnatal complications were included in study.
Exclusion Criteria:
- Women who had a major operation within the last 3years were excluded.
- Women who had chronic issues i.e diabetes, hypertension were excluded.
- Women who had a history of psychiatric disorders were excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diaphragmatic breathing along with aerobic exercises
Experimental Group (Group A) will receive both aerobic exercises and diaphragmatic breathing exercise.
Exercise programs will consist of 1 set of contractions per day and each set will include 30 repetitions for 6 weeks.
Exercise protocol consist of at least 150 minutes of moderate-intensity aerobic activity every week dividing the 150 minutes into 30-minute workouts on 5 days of the week or into smaller 10-minute sessions throughout each day will be carried out for 6 weeks
|
Exercise programs will consist of 1 set of contractions per day and each set will include 30 repetitions for 6 weeks.
Exercise protocol consist of at least 150 minutes of moderate-intensity aerobic activity every week dividing the 150 minutes into 30-minute workouts on 5 days of the week or into smaller 10-minute sessions throughout each day will be carried out for 6 weeks.
|
|
Active Comparator: Diaphragmatic breathing only without aerobic exercises
Active comparator (Group B) will receive only diaphragmatic breathing exercises.
Exercise programs will consist of 1 set of contractions per day and each set will include 30 repetitions for 6 weeks.
|
Exercise programs will consist of 1 set of contractions per day and each set will include 30 repetitions for 6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived stress scale
Time Frame: 6 Weeks
|
The Perceived Stress Scale is the most often used psychometric tool for assessing stress sensitivity.
It is an assessment of how difficult things in one's life are perceived to be.
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6 Weeks
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Pittsburgh sleep quality index
Time Frame: 6 Weeks
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The PSQI is a 19-item, self-reported questionnaire used to assess sleep quality.
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6 Weeks
|
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Fatigue severity scale
Time Frame: 6 Weeks
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The FSS assessment has nine statements that assess the intensity of your tiredness symptoms.
Read the information and mark a value from 1 to 7 depending on the how precisely it depicts your situation over the last week and how much you disagree or agree that now the claim pertains to yourself
|
6 Weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sabiha Arshad, M.phil, Riphah International University
Publications and helpful links
General Publications
- Buckley SJ. Executive Summary of Hormonal Physiology of Childbearing: Evidence and Implications for Women, Babies, and Maternity Care. J Perinat Educ. 2015;24(3):145-53. doi: 10.1891/1058-1243.24.3.145.
- Asadi M, Noroozi M, Alavi M. Factors Affecting Women's Adjustment to Postpartum Changes: A Narrative Review. Iran J Nurs Midwifery Res. 2020 Nov 7;25(6):463-470. doi: 10.4103/ijnmr.IJNMR_54_20. eCollection 2020 Nov-Dec.
- Kolovetsiou-Kreiner V, Moertl MG, Papousek I, Schmid-Zalaudek K, Lang U, Schlembach D, Cervar-Zivkovic M, Lackner HK. Maternal cardiovascular and endothelial function from first trimester to postpartum. PLoS One. 2018 May 21;13(5):e0197748. doi: 10.1371/journal.pone.0197748. eCollection 2018.
- Umazume T, Yamada T, Yamada S, Ishikawa S, Furuta I, Iwano H, Murai D, Hayashi T, Okada K, Morikawa M, Yamada T, Ono K, Tsutsui H, Minakami H. Morphofunctional cardiac changes in pregnant women: associations with biomarkers. Open Heart. 2018 Jul 16;5(2):e000850. doi: 10.1136/openhrt-2018-000850. eCollection 2018.
- Bett GC. Hormones and sex differences: changes in cardiac electrophysiology with pregnancy. Clin Sci (Lond). 2016 May 1;130(10):747-59. doi: 10.1042/CS20150710.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/22/0531
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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