Labor PainNCT05196841
The Effect of Fatima Ana's Hand on Birth Pain and Duration
A study testing Anastatica Hierochuntica in people with Labor Pain and Labor Long, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
Research Question: Does the Anastatica Hierochuntica have an effect on labor pain and duration? Methods: This study was planned as a a double blind randomized controlled experimental study. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Labor Long
- What is being tested?
- Anastatica Hierochuntica
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 1 Nov 2021
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having a singleton pregnancy at 38-42 weeks,
- Pregnant women who had spontaneous labor,
- Pregnant women with a healthy fetus,
- Pregnant women without any complications that may cause dystocia during labor,
- Pregnant women who did not receive analgesia and anesthesia during the first phase of labor,
- Planned vaginal delivery, pregnant women who volunteered to participate in the research
Who cannot join
- pregnant women with high-risk pregnancies, Planned caesarean delivery, pregnant women with chronic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Fatima Ana's Hand (Anastatica Hierochuntica) on Birth Pain and Duration: A Randomized Controlled Study
Research Question: Does the Anastatica Hierochuntica have an effect on labor pain and duration? Methods: This study was planned as a a double blind randomized controlled experimental study. The study was conducted with 60 pregnant women who were randomized between February 2019 and November 2020 at a university and private hospital located in Anatolia, Turkey.
Read the detailed description
Complementary treatment methods during the birth process are supportive therapies. It is applied to meet the physical and psychological care needs, to help cope with pain during childbirth, to increase the quality of life of pregnant women. Mind-body methods, alternative medical methods, biological-based treatment methods, manipulative and body-based methods, and energy therapy methods are used as complementary treatment methods in labor. The focus applied within the scope of mind-body methods is based on the principle of revealing the mental skill that improve bodily functions. One of the methods applied in this direction is Anastatica Hierochuntica.
Anastatika Hierochuntica is a herbaceous plant that can live 1000-2000 years, with dry leaves resembling a fist-closed hand in which it stores its seeds. Known as "Fatma Ana Eli" or "Meryem Ana Eli". This dry ball-shaped plant in the deserts of Namibia comes alive in the rain and turns to green color by opening the folds. After the rain, the leaves of the plant, which stores some water to pass through a new drought period, close again and take a dry appearance.
The plant Anastatica Hierochuntica is known to have a facilitating effect on labor and is frequently used for this purpose during labor. During childbirth, the Anastatica Hierochuntica plant is dropped into a bowl of water. It is believed that as the plant opens, labor will be easier, and the baby will flow like water.
Despite its frequent use, when the literature is examined, no studies hasve been found on the effect of Anastatica Hierochuntica on birth. For this reason, the study was conducted to evaluate the effect of Anastatica Hierochuntica on labor pain and duration.
- Conditions
- Labor Pain, Labor Long
- Being tested
- Anastatica Hierochuntica
- Keywords
- Labor pain, Labor duration, Midwife, Anastatica Hierochuntica
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anastatica HierochunticaBehavioural
During the sampling process, the researcher inquired through women who apply for pregnancy follow-up and contacted the mothers who had some inclusion criteria. Also, the researcher outlined the research plan and objectives. The participants were assessed based on the eligibility criteria and, if they were eligible and willing to participate in the study.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Anastatica Hierochuntica Receives: Behavioral: Anastatica Hierochuntica |
| Control group | No intervention | routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of labor pain
The primary outcomes included the severity of labor pain that was measured by VAS
Measured: 12 hours
Secondary outcomes (1)
Duration of the active phase of labor
The secondary outcomes included the duration of the active phase of labor and the second stage of delivery. The length of delivery stages was recorded in the partograph chart during labor and childbirth by the researcher.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Feb 2020
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
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.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hediye KARAKOC, PhD, Principal investigator, Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196841
- Sponsor's protocol ID
- KaratayUNI
- Status last verified
- Nov 2021
- First submitted
- 27 Nov 2021
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fatima Ana's Hand (Anastatica Hierochuntica) on Birth Pain and Duration: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05196841
- Acronym / sponsor ID
- KaratayUNI
- Conditions
- Labor Pain, Labor Long
- Keywords
- Labor pain, Labor duration, Midwife, Anastatica Hierochuntica
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 19 Jan 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.
Research Question: Does the Anastatica Hierochuntica have an effect on labor pain and duration? Methods: This study was planned as a a double blind randomized controlled experimental study. The study was conducted with 60 pregnant women who were randomized between February 2019 and November 2020 at a university and private hospital located in Anatolia, Turkey.
Detailed description
Complementary treatment methods during the birth process are supportive therapies. It is applied to meet the physical and psychological care needs, to help cope with pain during childbirth, to increase the quality of life of pregnant women. Mind-body methods, alternative medical methods, biological-based treatment methods, manipulative and body-based methods, and energy therapy methods are used as complementary treatment methods in labor. The focus applied within the scope of mind-body methods is based on the principle of revealing the mental skill that improve bodily functions. One of the methods applied in this direction is Anastatica Hierochuntica.
Anastatika Hierochuntica is a herbaceous plant that can live 1000-2000 years, with dry leaves resembling a fist-closed hand in which it stores its seeds. Known as "Fatma Ana Eli" or "Meryem Ana Eli". This dry ball-shaped plant in the deserts of Namibia comes alive in the rain and turns to green color by opening the folds. After the rain, the leaves of the plant, which stores some water to pass through a new drought period, close again and take a dry appearance.
The plant Anastatica Hierochuntica is known to have a facilitating effect on labor and is frequently used for this purpose during labor. During childbirth, the Anastatica Hierochuntica plant is dropped into a bowl of water. It is believed that as the plant opens, labor will be easier, and the baby will flow like water.
Despite its frequent use, when the literature is examined, no studies hasve been found on the effect of Anastatica Hierochuntica on birth. For this reason, the study was conducted to evaluate the effect of Anastatica Hierochuntica on labor pain and duration.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Anastatica HierochunticaAnastatica Hierochuntica |
| Control group | No intervention | –routine care |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Having a singleton pregnancy at 38-42 weeks,
- Pregnant women who had spontaneous labor,
- Pregnant women with a healthy fetus,
- Pregnant women without any complications that may cause dystocia during labor,
- Pregnant women who did not receive analgesia and anesthesia during the first phase of labor,
Key exclusion criteria (1 listed)
- pregnant women with high-risk pregnancies, Planned caesarean delivery, pregnant women with chronic diseases
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 |
|---|---|---|
| Anastatica HierochunticaDuring the sampling process, the researcher inquired through women who apply for pregnancy follow-up and contacted the mothers who had some inclusion criteria. Also, the researcher outlined the research plan and objectives. The participants were assessed based on the eligibility criteria and, if they were eligible and willing to participate in the study. | Behavioural | Experimental group |
Primary outcome
Severity of labor pain
Time frame: 12 hours
The primary outcomes included the severity of labor pain that was measured by VAS
1 secondary outcome
Duration of the active phase of labor
Time frame: 12 hours
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 Nov 2023.
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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.
Hediye KARAKOC, PhD principal investigator
Karatay 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 Anastatica Hierochuntica in people with Labor Pain and Labor Long, run by KTO Karatay 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 6 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 15 Nov 2023. 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 (time frame: 12 hours). 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 15 Nov 2023.