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Focusing on Maryam's Flower at Labor

Primary Purpose

Labor Pain, Satisfaction

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Foccusing on Maryam's Flower
Sponsored by
Balikesir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Labor Pain focused on measuring comfort at labor, labor pain, Maryam's flower, focused attention, birth satisfaction

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • expected vaginal delivery
  • single healthy fetus
  • primipara
  • in the first phase of the labor
  • 1 cm cervical dilatation

Exclusion Criteria:

  • multipara
  • risky pregnancy
  • child with complications
  • multiple pregnancies
  • premature delivery
  • after 1 cm cervical dilatation

Sites / Locations

  • Hülya TÜRKMEN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Maryam's Flower Group

Control Group

Arm Description

Maryam's flower was placed in a bowl of water and left in the room of the pregnant women who were at 1 cm cervical dilatation and in the first phase of the labor. It was explained to the pregnant women that the leaves of the plant would open up in the water, and they were asked to imagine that the birth canal would simultaneously open up. In effect, they were told to focus on the opening of these leaves during the course of the labor

All the pregnant women, those in the control group, were provided with standard midwifery care.

Outcomes

Primary Outcome Measures

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
duration of active phase and transition phase of labor (4-10cm cervical dilatation)
duration of active phase and transition phase of labor (4-10cm cervical dilatation)
comfort level at labor
Childbirth Comfort Questionnaire (CCQ) 5-point Likert-type- minimum 9 and maximum 45 points are obtained from the scale. higher scores mean a better comfort

Secondary Outcome Measures

birth satisfaction level.
The Birth Satisfaction Scale, Likert-type scale- minimum 30 and maximum 150 points are obtained from the scale. higher scores mean a better birth satisfaction

Full Information

First Posted
May 11, 2020
Last Updated
May 18, 2020
Sponsor
Balikesir University
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1. Study Identification

Unique Protocol Identification Number
NCT04393870
Brief Title
Focusing on Maryam's Flower at Labor
Official Title
Effect of Focusing on Maryam's Flower During the First Phase of the Labor
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Balikesir 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
Objective: To determine the effect that focusing attention on the plant, Maryam's Flower, has on pregnant women's perception of pain, level of comfort and labor satisfaction during the first phase of labor. Method: This randomized controlled experimental study was conducted with an intervention group (n=61) and control group (n=63) involving primipara pregnant women who were at 1 cm cervical dilatation. The pregnant women in the intervention group were asked to focus their attention on Maryam's flower opening its leaf buds and imagine the labor's progress during the course of their labor. The control group only received standard midwifery care. Each group was administered the VAS at specific times (at 4-5 cm, 6-7 cm, and 8-9 cm cervical dilatation) to determine their level of labor pain. The Childbirth Comfort Questionnaire (CCQ) was also administered when the women were at 4-5 cm and 8-9 cm cervical dilatation to determine their level of birth comfort. The duration of labor was monitored using a partograph form. Finally, the Birth Satisfaction Scale was applied to determine the women's satisfaction with the labor in the 2nd hour of the postpartum period.
Detailed Description
Design and Settings This randomized controlled experimental study was conducted in the delivery room of the Atatürk City Hospital in Balıkesir, Turkey between the dates of May 2019 and January 2020. Participants The sample size was determined using G * Power 3 power calculations, taking into consideration previous studies on the effect of positive mental imagination during labor. Impact predictions were obtained from the findings derived from Yavari et al., which specified the pain intensity during 6-7 cm cervical dilatation to be 6.73 ± 1.34 in the positive mental imagination group, and 7.63 ± 1.64 in the control group (18). This study expected to detect differences similar to those reported by Yavari et al. The sample size was determined to be 61 for each group. Maryam's flower group included 61 pregnant women, while the control group included 63 pregnant women. In the Maryam's flower group, 6 pregnant women and in the control group, 2 pregnant women underwent cesarean sections, therefore, the study was completed with 55 pregnant women from the Maryam's flower group and 61 pregnant women from the control group (The pregnant women underwent cesarean sections after 6-7 cm cervical dilatation). The power analysis indicated that the sample size of the study had a power of 94% with α = 0.05. The decrease observed in labor pain for the Maryam's flower group at 6-7 cm cervical dilatation had an effect size of 0.59 when compared to the control group. Study inclusion criteria included pregnant women who expected vaginal delivery and a single healthy fetus, who were primipara and in the first phase of the labor, and who were at 1 cm cervical dilatation. Pregnant women who were multipara, had a risky pregnancy, a child with complications, multiple pregnancies, or a premature delivery and those who delivered after 1 cm cervical dilatation were excluded from the study. Single-blind block randomization was performed with closed opaque envelopes, where 61 of the 124 envelopes include pieces of paper on which were written "intervention" and 63 on which were written "control". The randomization sequence was determined by a statistician through a computerized research randomizer. The intervention group focused on Maryam's flower throughout the delivery, while the control group was provided standard midwifery care. Data Collection The participating pregnant women who were in the first phase of labor and at 1 cm cervical dilatation were administered an introductory information form. In the intervention group, Maryam's flower was placed in a bowl of water once the women were at 1 cm cervical dilatation, and the pregnant women were asked to focus on the plant. Each group, that is, the intervention group and the control group, were administered the Visual Analog Scale (VAS-1) when they were at 4-5 cm cervical dilatation and the Childbirth Comfort Questionnaire, to detect their levels of birth comfort, and the VAS-2 when they were at 6-7 cm cervical dilatation. Once the women reached 8-10 cm cervical dilation, they were asked to respond to the VAS-3 and Childbirth Comfort Questionnaire. The Birth Satisfaction Scale was used to determine the level of postnatal satisfaction. Measures The study data were collected through the Pregnant Information Form, the VAS, the Partograph form, the Childbirth Comfort Questionnaire, and the Birth Satisfaction Scale. The Pregnant Information Form (PIF): This form included questions on the sociodemographic, gynecological, and obstetric characteristics of the pregnant women. Visual Analog Scale (VAS): This scale was used to determine the level of labor pain. The scale features a 10-cm long vertical line, with 0 at the bottom end and 10 at the top end. The VAS was administered when the women were at 4-5 cm, 6-7 cm, and 8-10 cm cervical dilatation, and the women completed the scale themselves Partograph Form: This form was used to determine the duration of the first phase of the labor process (active phase and transition phase). Childbirth Comfort Questionnaire (CCQ): This questionnaire was developed by Kerri Durnell Schuling and Carolyn Sampselle in 2003 (7). The Turkish reliability and validity study of the questionnaire was conducted by Potur et al. (2015) (11), who reported that the CCQ included physical, environmental, and psychospiritual subscales and relief and transcendence levels. The questionnaire features 9 items, each of which are evaluated based on a 5-point Likert-type scale, where 1 represented strongly disagree and 5 represented strongly agree. The minimum and maximum scores possible on the scale are 9 and 45, respectively, with higher scores representing higher levels of comfort and lower scores representing lower levels. Potur et al. found Cronbach's alpha reliability coefficient to be 0.75. The CCQ was administered twice in this study, once at 4-5 cm cervical dilatation and once at 8-9 cm cervical dilatation. The Birth Satisfaction Scale (BSS): The Turkish reliability and validity study of this scale developed by Hollins Martin and Fleming was conducted by Çoşar et al. (2015). The scale is a Likert-type scale comprised of 30 questions. The minimum and maximum scores possible on the scale are 30 and 150, respectively. Higher scores indicate higher birth satisfaction. An analysis conducted to determine the internal consistency of the BSS found the Cronbach's alpha value to be 0.62. The BSS was administered at the 2nd hour of the postnatal period. Intervention Maryam's flower was placed in a bowl of water and left in the room of the pregnant women who were at 1 cm cervical dilatation and in the first phase of the labor. It was explained to the pregnant women that the leaves of the plant would open up in the water, and they were asked to imagine that the birth canal would simultaneously open up. In effect, they were told to focus on the opening of these leaves during the course of the labor (Pictures 1 and 2). All the pregnant women, those in the control group and in intervention group, were provided with standard midwifery care. As part of the standard midwifery care given to the pregnant women, follow-up of cervical dilatation and effacement, contraction, fetal heart rate, and vital signs were monitored. The pregnant women were given information on breathing and pushing techniques. Moreover, induction was performed on all the pregnant women. in labor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Satisfaction
Keywords
comfort at labor, labor pain, Maryam's flower, focused attention, birth satisfaction

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Maryam's Flower Group
Arm Type
Experimental
Arm Description
Maryam's flower was placed in a bowl of water and left in the room of the pregnant women who were at 1 cm cervical dilatation and in the first phase of the labor. It was explained to the pregnant women that the leaves of the plant would open up in the water, and they were asked to imagine that the birth canal would simultaneously open up. In effect, they were told to focus on the opening of these leaves during the course of the labor
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
All the pregnant women, those in the control group, were provided with standard midwifery care.
Intervention Type
Other
Intervention Name(s)
Foccusing on Maryam's Flower
Intervention Description
Effect of Focusing on Maryam's Flower During the First Phase of the labor
Primary Outcome Measure Information:
Title
severity of labor pain by VAS
Description
Visual Analog Scale The scale features a 10-cm long vertical line, with 0 at the bottom end and 10 at the top end
Time Frame
immediately after the intervention
Title
duration of active phase and transition phase of labor (4-10cm cervical dilatation)
Description
duration of active phase and transition phase of labor (4-10cm cervical dilatation)
Time Frame
during the procedure
Title
comfort level at labor
Description
Childbirth Comfort Questionnaire (CCQ) 5-point Likert-type- minimum 9 and maximum 45 points are obtained from the scale. higher scores mean a better comfort
Time Frame
immediately after the intervention
Secondary Outcome Measure Information:
Title
birth satisfaction level.
Description
The Birth Satisfaction Scale, Likert-type scale- minimum 30 and maximum 150 points are obtained from the scale. higher scores mean a better birth satisfaction
Time Frame
2nd hour of the postnatal period.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: expected vaginal delivery single healthy fetus primipara in the first phase of the labor 1 cm cervical dilatation Exclusion Criteria: multipara risky pregnancy child with complications multiple pregnancies premature delivery after 1 cm cervical dilatation
Facility Information:
Facility Name
Hülya TÜRKMEN
City
Balikesir
ZIP/Postal Code
10100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33371726
Citation
Turkmen H, Cetinkaya S, Kilic H, Apay E, Karamuftuoglu D, Yoruk S, Ozkirim E. Effect of Focusing on Maryam's Flower During the First Stage of the Labor on the Labor Pain, Labor Duration, and Levels of Comfort and Satisfaction. Clin Nurs Res. 2021 Jul;30(6):780-789. doi: 10.1177/1054773820984911. Epub 2020 Dec 29.
Results Reference
derived

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Focusing on Maryam's Flower at Labor

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