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Effects of Diaphragmatic Breathing With and Without Aerobic Exercise on Stress, Fatigue and Sleep Quality

Primary Purpose

Stress, Fatigue, Sleep

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Diaphragmatic breathing
Aerobic exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress focused on measuring Diaphragmatic Breathing, Exercise, Fatigue, Postpartum, Stress

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Jinnah Hospital, gynae ward

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Diaphragmatic breathing along with aerobic exercises

Diaphragmatic breathing only without aerobic exercises

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Perceived stress scale
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.
Pittsburgh sleep quality index
The PSQI is a 19-item, self-reported questionnaire used to assess sleep quality.
Fatigue severity scale
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

Secondary Outcome Measures

Full Information

First Posted
July 24, 2022
Last Updated
December 13, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05474508
Brief Title
Effects of Diaphragmatic Breathing With and Without Aerobic Exercise on Stress, Fatigue and Sleep Quality
Official Title
Effects of Diaphragmatic Breathing With and Without Aerobic Exercise on Stress, Fatigue and Sleep Quality Among Post Postpartum Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Fatigue, Sleep
Keywords
Diaphragmatic Breathing, Exercise, Fatigue, Postpartum, Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diaphragmatic breathing along with aerobic exercises
Arm Type
Experimental
Arm Description
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
Arm Title
Diaphragmatic breathing only without aerobic exercises
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Diaphragmatic breathing
Intervention Description
Exercise programs will consist of 1 set of contractions per day and each set will include 30 repetitions for 6 weeks.
Intervention Type
Other
Intervention Name(s)
Aerobic exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Perceived stress scale
Description
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.
Time Frame
6 Weeks
Title
Pittsburgh sleep quality index
Description
The PSQI is a 19-item, self-reported questionnaire used to assess sleep quality.
Time Frame
6 Weeks
Title
Fatigue severity scale
Description
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
Time Frame
6 Weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Postpartum women
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabiha Arshad, M.Phil
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinnah Hospital, gynae ward
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26834435
Citation
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.
Results Reference
background
PubMed Identifier
33747834
Citation
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.
Results Reference
background
PubMed Identifier
29782509
Citation
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.
Results Reference
background
PubMed Identifier
30057771
Citation
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.
Results Reference
background
PubMed Identifier
27128800
Citation
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.
Results Reference
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Effects of Diaphragmatic Breathing With and Without Aerobic Exercise on Stress, Fatigue and Sleep Quality

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