Labor Pain and to Reduce PainNCT07077577
Holistic Birth Experiences: A Qualitative Exploration
A study testing Holistic Birth Approach in people with Labor Pain and to Reduce Pain, run by University of the Punjab at 1 site in Pakistan.
Trial summary
This quasi experimental qualitative study aims to investigate whether Holistic Birth Approaches is useful technique for improved women's child birth experience. The study objectives include investigating the effect of holistic birth strategies on birth process and how it addresses the fear and anxiety issues during… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain and to Reduce Pain
- What is being tested?
- Holistic Birth Approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Apr 2025to 5 Jun 2025
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
hospital from Southern Punjab
Dera Ghazi Khan, Punjab Province, 32200
About this study
Official title: Exploring Mothers' Lived Experiences of a Holistic Birth Strategy Intervention for Labor Pain Management: A Phenomenological Qualitative Study in Southern Punjab Pakistan
This quasi experimental qualitative study aims to investigate whether Holistic Birth Approaches is useful technique for improved women's child birth experience. The study objectives include investigating the effect of holistic birth strategies on birth process and how it addresses the fear and anxiety issues during child birth. Moreover, measuring level of satisfaction among women who received holistic strategies during birth was also included in this study. Investigator will also examine the importance of holistic approach for labor pain and delivery management. The study will be conducted in chosen public healthcare facilities that either offers or gives holistic birth methods. The women in labor pain who arrived at hospital where holistic approach is offered for delivery will be included for study.
Read the 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
- Conditions
- Labor Pain and to Reduce Pain
- Being tested
- Holistic Birth Approach
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holistic Birth ApproachProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Use of Holistic Approach techniques during delivery, single arm quasi experimental study | Experimental | this is single arm quasi experimental study in which intervention is given to women at time of delivery Receives: Procedure: Holistic Birth Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Benefits of Holistic Birth Approach Use
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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start5 Apr 2025
- Primary completion5 Apr 2025
- Study completion5 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor Pain and to Reduce PainStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Punjab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Javeria Saleem, University of the Punjab
- Investigators
- Dr Nadia Maryam, Mphil PH, Principal investigator, University of the Punjab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077577
- Sponsor's protocol ID
- Holistic Approach NM
- Status last verified
- Jul 2025
- First submitted
- 18 Jun 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: due to the issues of confidentiality and privacy of patients data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Mothers' Lived Experiences of a Holistic Birth Strategy Intervention for Labor Pain Management: A Phenomenological Qualitative Study in Southern Punjab Pakistan
- ClinicalTrials.gov ID
- NCT07077577
- Acronym / sponsor ID
- Holistic Approach NM
- Conditions
- Labor Pain and to Reduce Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of the PunjabUniversity, hospital or other
- Study start
- 5 Apr 2025 (actual)
- Primary completion
- 5 Apr 2025 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 22 Jul 2025 (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.
This quasi experimental qualitative study aims to investigate whether Holistic Birth Approaches is useful technique for improved women's child birth experience. The study objectives include investigating the effect of holistic birth strategies on birth process and how it addresses the fear and anxiety issues during child birth. Moreover, measuring level of satisfaction among women who received holistic strategies during birth was also included in this study. Investigator will also examine the importance of holistic approach for labor pain and delivery management. The study will be conducted in chosen public healthcare facilities that either offers or gives holistic birth methods. The women in labor pain who arrived at hospital where holistic approach is offered for delivery will be included for study.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of Holistic Approach techniques during delivery, single arm quasi experimental study | Experimental | Procedure: Holistic Birth Approachthis is single arm quasi experimental study in which intervention is given to women at time of delivery |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Holistic Birth ApproachHolistic 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. | Procedure or surgery | Use of Holistic Approach techniques during delivery, single arm quasi experimental study |
Primary outcome
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)
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
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 22 Jul 2025.
- Individual participant dataSharing planned: No. due to the issues of confidentiality and privacy of patients data will not be shared
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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.
Dr Nadia Maryam, Mphil PH principal investigator
University of the Punjab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holistic Birth Approach in people with Labor Pain and to Reduce Pain, run by University of the Punjab 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 1 inclusion and 1 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 22 Jul 2025. 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?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2025.