ClinicalTrials.gg
CompletedNCT04393870Updated May 19, 2020

Focusing on Maryam's Flower at Labor

An interventional study of Foccusing on Maryam's Flower in Labor Pain and Satisfaction, sponsored by Balikesir University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-19.

Sponsored by Balikesir University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled May 2019, registered May 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Labor Pain
  • Satisfaction

Keywords

  • comfort at labor
  • labor pain
  • Maryam's flower
  • focused attention
  • birth satisfaction
03

In context

Labor Pain

410 studies on the registry are indexed under Labor Pain; 69 are open to participants now.

This study's enrollment of 124 is above the median of 100 across 336 interventional studies indexed under Labor Pain.

Browse Labor Pain studies →

Lead sponsor

Balikesir University is the lead sponsor of 59 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • multipara
  • risky pregnancy
  • child with complications
  • multiple pregnancies
  • premature delivery
  • after 1 cm cervical dilatation
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
124 participants (actual)

Study arms

  • Experimental
    Maryam's Flower Group

    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

    Other: Foccusing on Maryam's Flower

  • No intervention
    Control Group

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

Interventions

  • OtherFoccusing on Maryam's Flower

    Effect of Focusing on Maryam's Flower During the First Phase of the labor

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: immediately after the intervention

  2. 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)

    Time frame: during the procedure

  3. 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

    Time frame: immediately after the intervention

Secondary outcomes

  1. 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

    Time frame: 2nd hour of the postnatal period.

07

Study locations

1 site
  • Hülya TÜRKMEN
    Balıkesir, 10100, Turkey (Türkiye)
08

References and documents

Publications

  • 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. PubMed 33371726 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2019 to primary completion in Jan 2020, 8 months.

Of 183 non-industry interventional studies with no phase under Labor Pain, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's 8 months is below that.

Counting every sponsor, half of 185 studies reached it within 9 months; a quarter within 5 and three quarters within 14.

How these figures are worked out, and which studies are left out of them.

Registered
May 11, 2020
First posted
May 19, 2020
StartActual
May 1, 2019
Primary completionActual
Jan 31, 2020
CompletionActual
Jan 31, 2020
Last update
May 19, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04393870
Lead sponsor
Balikesir University
Responsible party
Hülya TÜRKMEN (Lecturer (PhD), Balikesir University) — Principal investigator
First posted
May 19, 2020
Start date
May 1, 2019
Primary completion
Jan 31, 2020
Completion
Jan 31, 2020
Last update
May 19, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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