StressNCT05474508
Effects of Diaphragmatic Breathing With and Without Aerobic Exercise on Stress, Fatigue and Sleep Quality
A study testing Diaphragmatic breathing and Aerobic exercises in people with Stress and Fatigue, run by Riphah International University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- What is being tested?
- Diaphragmatic breathing and Aerobic exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2022to 10 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Diaphragmatic breathing, Aerobic exercises
- Keywords
- Diaphragmatic Breathing, Exercise, Fatigue, Postpartum, Stress
- Medical subject headings
- Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic breathingOther
Exercise programs will consist of 1 set of contractions per day and each set will include 30 repetitions for 6 weeks.
Aerobic exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Diaphragmatic breathing along with aerobic exercises | Experimental | 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 Receives: Other: Diaphragmatic breathing; Other: Aerobic exercises |
| Diaphragmatic breathing only without aerobic exercises | Active comparator | 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. Receives: Other: Diaphragmatic breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Weeks
Pittsburgh sleep quality index
The PSQI is a 19-item, self-reported questionnaire used to assess sleep quality.
Measured: 6 Weeks
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
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start1 Jan 2022
- Primary completion1 Aug 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabiha Arshad, M.Phil, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474508
- Sponsor's protocol ID
- REC/RCR & AHS/22/0531
- Status last verified
- Dec 2022
- First submitted
- 24 Jul 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26834435Asadi 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.
PubMed 33747834Kolovetsiou-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.
PubMed 29782509Umazume 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.
PubMed 30057771Bett 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.
PubMed 27128800
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diaphragmatic Breathing With and Without Aerobic Exercise on Stress, Fatigue and Sleep Quality Among Post Postpartum Women
- ClinicalTrials.gov ID
- NCT05474508
- Acronym / sponsor ID
- REC/RCR & AHS/22/0531
- Keywords
- Diaphragmatic Breathing, Exercise, Fatigue, Postpartum, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic breathing along with aerobic exercises | Experimental | Other: Diaphragmatic breathing, Other: Aerobic exercisesExperimental 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 |
| Diaphragmatic breathing only without aerobic exercises | Active comparator | Other: Diaphragmatic breathingActive 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragmatic breathingExercise programs will consist of 1 set of contractions per day and each set will include 30 repetitions for 6 weeks. | Other | Diaphragmatic breathing along with aerobic exercises, Diaphragmatic breathing only without aerobic exercises |
| Aerobic exercisesExercise 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. | Other | Diaphragmatic breathing along with aerobic exercises |
Primary outcome
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.
Pittsburgh sleep quality index
Time frame: 6 Weeks
The PSQI is a 19-item, self-reported questionnaire used to assess sleep quality.
Fatigue severity scale
Time frame: 6 Weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Background: PubMed 26834435Buckley 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.
- Background: PubMed 33747834Asadi 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.
- Background: PubMed 29782509Kolovetsiou-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.
- Background: PubMed 30057771Umazume 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.
- Background: PubMed 27128800Bett 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabiha Arshad, M.Phil principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic breathing and Aerobic exercises in people with Stress and Fatigue, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived stress scale (time frame: 6 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05474508, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.