- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07077577
- Original Trial
Holistic Birth Experiences: A Qualitative Exploration
Exploring Mothers' Lived Experiences of a Holistic Birth Strategy Intervention for Labor Pain Management: A Phenomenological Qualitative Study in Southern Punjab Pakistan
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study exploration involves primarily determining the usefulness of Holistic Birth Approaches on women birth experiences especially related to labor pain, fear and anxiety challenges during child birth. Measuring Women's level of Satisfaction associates with using Holistic Birth Approaches is also another primary study objective. Further, evaluating about the factors that act as facilitators and barriers in Holistic Birth Approach implementation in Pakistan. Pregnant Women in labor pain who arrived in chosen public healthcare facilities that offers Holistic Birth Approaches for delivery will be screened for eligibility. Women willing to participate will be selected for interventional study. The included healthcare facilities must use non-clinical birth support practices such as breathing techniques, massage, hydrotherapy, aromatherapy, attendance of a midwife or doula, and emotional support for labor management.
The intervention method includes pre and post interviews. During pre-intervention interviews will be conducted to understand the women previous experiences for labor management if applicable, perceptions, knowledge about holistic approach and attitudes with respect to delivery management. Then with consent of women the holistic method will be employed during delivery for labor management. Then, after delivery post intervention interviews will be conducted to know the perceived benefits of holistic methods for women during delivery along with their intentions for future to implement or improve holistic techniques for better birth process management
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Punjab
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Dera Ghazi Khan, Punjab, Pakistan, 32200
- hospital from Southern Punjab
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pregnant reproductive age women (18-40 years) who will be willing to participate and understand Urdu language will be include in study who arrived at public health care facility for delivery and is experiencing labor pain The women from those healthcare facilities will be include that provides holistic birth approaches to women for improved birth experience particularly for labor pain, fear of birth and mother's satisfaction
Exclusion Criteria:
- Those who are not willing for interview will not be included in study. Women having serious medical condition requiring inpatient and outpatient care. Women younger than 18 and more than 40 years.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Use of Holistic Approach techniques during delivery, single arm quasi experimental study
this is single arm quasi experimental study in which intervention is given to women at time of delivery
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Holistic Birth Approach involves use of non pharmacological techniques for better labor process management with less experience of pain, fear and maternal satisfaction to women delivering the baby through normal delivery method.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Benefits of Holistic Birth Approach Use
Time Frame: Pre Intervention interviews: Pre-delivery (when women got admitted to hospital for delivery) Intervention: At time of delivery Post Intervention interviews: Post-delivery (within one or two days after delivery when women was comfortable for interviews)
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Pre Intervention; Evaluating pregnant women perspectives, experiences, knowledge and expectations before receiving any holistic birth approach Intervention Phase: Holistic Birth Approaches employed to women Post Intervention; Birth Experiences after receiving Holistic Birth Approach use
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Pre Intervention interviews: Pre-delivery (when women got admitted to hospital for delivery) Intervention: At time of delivery Post Intervention interviews: Post-delivery (within one or two days after delivery when women was comfortable for interviews)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dr Nadia Maryam, Mphil PH, University of the Punjab
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
- Holistic Approach NM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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