Labor PainNCT06128759
Focusing on the Maryam's Flower During the Birth
A study testing Focusing on Maryam's Flower in people with Labor Pain, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
To determine the Effect of Focusing on the Virgin Mary Flower during the Birth Process on Labor Pain, Labor Duration and Perceived Fatigue in Birth. Method: The study will be completed in a randomized controlled manner with a total of 126 primiparous pregnant women, 63 in the experimental group and 63 in the control… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Focusing on Maryam's Flower
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Nov 2023to 3 Apr 2024
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being 18 years or older,
- being in 37-42 weeks of pregnancy,
- being primiparous,
- having a single healthy fetus,
- cervical dilatation not more than 3 cm.the one which,
- in the first stage of labor,
- Does not have any complications preventing vaginal birth,
- volunteer women who do not have disabilities in communication and perception
Who cannot join
- maternal and fetal complications
- pregnant with assisted reproductive techniques,
- having a presentation anomaly,
- having a twin pregnancy,
- electing cesarean section,
- Women whose cervical dilatation exceeds 3 cm and who are not willing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Focusing on the Maryam's Flower During the Birth Process on Labor Pain, Labor Duration and Perceived Fatigue in Birth
To determine the Effect of Focusing on the Virgin Mary Flower during the Birth Process on Labor Pain, Labor Duration and Perceived Fatigue in Birth.
Method: The study will be completed in a randomized controlled manner with a total of 126 primiparous pregnant women, 63 in the experimental group and 63 in the control group. Pregnant women in the experimental group will focus on the Virgin Mary flower in the water-filled jar and imagine that their uterus and birth path are opening like the branches of the Virgin Mary flower that blooms as labor pains come. There will be no intervention in the control group other than routine midwifery care. Research data will be collected with the Pregnant Introduction and Birth Process Follow-up Form, Visual Analog Scale, and Visual Similarity Scale for Fatigue.
Read the detailed description
Design and Settings: This randomized controlled experimental study will conducted in the delivery room of the, Turkey between the dates of November 2023 and April 2024
- Conditions
- Labor Pain
- Being tested
- Focusing on Maryam's Flower
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focusing on Maryam's FlowerOther
Also called Foccusing on Maryam's Flower
Effect of Focusing on Maryam's Flower During the First Phase of the labor
| Study group | Role | What they receive |
|---|---|---|
| Maryam's Flower Group | Experimental | Maryam's flower will place in a bowl of water and left in the room of the pregnant women who will at 1 cm cervical dilatation and in the first phase of the labor. It will explain to the pregnant women that the leaves of the plant would open up in the water, and they will ask to imagine that the birth canal would simultaneously open up. In effect, they will told to focus on the opening of these leaves during the course of the labor.. After birth, the flower used only as a focusing method will be removed from the water and its water will be poured. Receives: Other: Focusing on Maryam's Flower |
| control group | No intervention | will provided with standard midwifery care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of labor pain by VAS
Visual Analog Scale: The scale features a 10-cm long vertical line, with 0 at the bottom end and 10 at the top end
Measured: immediately after intervention
Visual Similarity Scale for Fatigue
The scale consists of two subscales, fatigue and energy, and 18 items. There are 10 cm long horizontal lines with positive expressions at one end and negative expressions at the other end of the YİBGS. While the items of the fatigue subscale progress from positive to negative, the energy subscale has the opposite order. The lowest score obtained from the fatigue subscale is 0 and the highest score is 130. In the energy subscale, scores range from 0 to 50.
Measured: immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start21 Nov 2023
- Primary completion3 Apr 2024
- Study completion3 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sümeyye BAL, Ondokuz Mayıs University
- Investigators
- Sümeyye BAL, Study chair, Ondokuz Mayıs UniversitySümeyye BAL, Principal investigator, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128759
- Sponsor's protocol ID
- 2022/294
- Status last verified
- Oct 2024
- First submitted
- 8 Nov 2023
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Focusing on the Maryam's Flower During the Birth Process on Labor Pain, Labor Duration and Perceived Fatigue in Birth
- ClinicalTrials.gov ID
- NCT06128759
- Acronym / sponsor ID
- 2022/294
- Conditions
- Labor Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 13 Nov 2023 (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.
To determine the Effect of Focusing on the Virgin Mary Flower during the Birth Process on Labor Pain, Labor Duration and Perceived Fatigue in Birth.
Method: The study will be completed in a randomized controlled manner with a total of 126 primiparous pregnant women, 63 in the experimental group and 63 in the control group. Pregnant women in the experimental group will focus on the Virgin Mary flower in the water-filled jar and imagine that their uterus and birth path are opening like the branches of the Virgin Mary flower that blooms as labor pains come. There will be no intervention in the control group other than routine midwifery care. Research data will be collected with the Pregnant Introduction and Birth Process Follow-up Form, Visual Analog Scale, and Visual Similarity Scale for Fatigue.
Detailed description
Design and Settings: This randomized controlled experimental study will conducted in the delivery room of the, Turkey between the dates of November 2023 and April 2024
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maryam's Flower Group | Experimental | Other: Focusing on Maryam's FlowerMaryam's flower will place in a bowl of water and left in the room of the pregnant women who will at 1 cm cervical dilatation and in the first phase of the labor. It will explain to the pregnant women that the leaves of the plant would open up in the water, and they will ask to imagine that the birth canal would simultaneously open up. In effect, they will told to focus on the opening of these leaves during the course of the labor.. After birth, the flower used only as a focusing method will be removed from the water and its water will be poured. |
| control group | No intervention | –will provided with standard midwifery care. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Being 18 years or older,
- being in 37-42 weeks of pregnancy,
- being primiparous,
- having a single healthy fetus,
- cervical dilatation not more than 3 cm.the one which,
Key exclusion criteria (6 listed)
- maternal and fetal complications
- pregnant with assisted reproductive techniques,
- having a presentation anomaly,
- having a twin pregnancy,
- electing cesarean section,
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 |
|---|---|---|
| Focusing on Maryam's FlowerAlso: Foccusing on Maryam's FlowerEffect of Focusing on Maryam's Flower During the First Phase of the labor | Other | Maryam's Flower Group |
Primary outcome
severity of labor pain by VAS
Time frame: immediately after intervention
Visual Analog Scale: The scale features a 10-cm long vertical line, with 0 at the bottom end and 10 at the top end
Visual Similarity Scale for Fatigue
Time frame: immediately after intervention
The scale consists of two subscales, fatigue and energy, and 18 items. There are 10 cm long horizontal lines with positive expressions at one end and negative expressions at the other end of the YİBGS. While the items of the fatigue subscale progress from positive to negative, the energy subscale has the opposite order. The lowest score obtained from the fatigue subscale is 0 and the highest score is 130. In the energy subscale, scores range from 0 to 50.
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 23 Oct 2024.
- 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.
Sümeyye BAL study chair
Ondokuz Mayıs University
Sümeyye BAL principal investigator
Ondokuz Mayıs 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 Focusing on Maryam's Flower in people with Labor Pain, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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 8 inclusion and 6 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 23 Oct 2024. 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 Turkey (Türkiye). 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?
severity of labor pain by VAS (time frame: immediately after intervention). The study lists 2 primary outcomes in all. 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 23 Oct 2024.