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The Effect of Anastatica Hierochuntica on Birth Pain and Duration

Primary Purpose

Labor Pain, Labor Long

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Anastatica Hierochuntica
Sponsored by
KTO Karatay University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Labor Pain focused on measuring Labor pain, Labor duration, Midwife, Anastatica Hierochuntica

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

pregnant women with high-risk pregnancies, Planned caesarean delivery, pregnant women with chronic diseases

Sites / Locations

  • KTO Karatay University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

Anastatica Hierochuntica

routine care

Outcomes

Primary Outcome Measures

Severity of labor pain
The primary outcomes included the severity of labor pain that was measured by VAS

Secondary Outcome Measures

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.

Full Information

First Posted
November 27, 2021
Last Updated
January 18, 2022
Sponsor
KTO Karatay University
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1. Study Identification

Unique Protocol Identification Number
NCT05196841
Brief Title
The Effect of Anastatica Hierochuntica on Birth Pain and Duration
Official Title
The Effect of Anastatica Hierochuntica on Birth Pain and Duration: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
November 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KTO Karatay University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Labor Long
Keywords
Labor pain, Labor duration, Midwife, Anastatica Hierochuntica

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Anastatica Hierochuntica
Arm Title
Control group
Arm Type
No Intervention
Arm Description
routine care
Intervention Type
Behavioral
Intervention Name(s)
Anastatica Hierochuntica
Intervention Description
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.
Primary Outcome Measure Information:
Title
Severity of labor pain
Description
The primary outcomes included the severity of labor pain that was measured by VAS
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Duration of the active phase of labor
Description
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.
Time Frame
12 hours

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: pregnant women with high-risk pregnancies, Planned caesarean delivery, pregnant women with chronic diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hediye KARAKOC, PhD
Organizational Affiliation
Karatay University
Official's Role
Principal Investigator
Facility Information:
Facility Name
KTO Karatay University
City
Konya
State/Province
Karatay
Country
Turkey

12. IPD Sharing Statement

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The Effect of Anastatica Hierochuntica on Birth Pain and Duration

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