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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05474508
Other study ID # REC/RCR & AHS/22/0531
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date August 10, 2022

Study information

Verified date December 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date August 10, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Diaphragmatic breathing
Exercise programs will consist of 1 set of contractions per day and each set will include 30 repetitions for 6 weeks.
Aerobic exercises
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.

Locations

Country Name City State
Pakistan Jinnah Hospital, gynae ward Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 Weeks
Primary Pittsburgh sleep quality index The PSQI is a 19-item, self-reported questionnaire used to assess sleep quality. 6 Weeks
Primary 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 6 Weeks
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