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Labor PainNCT04393870

Focusing on Maryam's Flower at Labor

A study testing Foccusing on Maryam's Flower in people with Labor Pain and Satisfaction, run by Balikesir University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Labor Pain, Satisfaction
What is being tested?
Foccusing on Maryam's Flower
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2019to 31 Jan 2020
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 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hülya TÜRKMEN

    Balıkesir, 10100

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Focusing on Maryam's Flower During the First Phase of the Labor

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.

Being tested
Foccusing on Maryam's Flower
Keywords
comfort at labor, labor pain, Maryam's flower, focused attention, birth satisfaction
Medical subject headings
Labor Pain, Personal Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Foccusing on Maryam's FlowerOther

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

Study groups in NCT04393870
Study groupRoleWhat they receive
Maryam's Flower GroupExperimentalMaryam'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
Receives: Other: Foccusing on Maryam's Flower
Control GroupNo interventionAll the pregnant women, those in the control group, were provided with standard midwifery care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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)

    Measured: 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

    Measured: immediately after the intervention

Secondary outcomes (1)
  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

    Measured: 2nd hour of the postnatal period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2020
  2. Study start1 May 2019
  3. Primary completion31 Jan 2020
  4. Study completion31 Jan 2020

Resources

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
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04393870
Sponsor's protocol ID
BalıkesirH
Status last verified
May 2020
First submitted
11 May 2020
Last updated
19 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Foccusing on Maryam's Flower in people with Labor Pain and Satisfaction, run by Balikesir 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 5 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 19 May 2020. 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 the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04393870, which also lists 1 linked publication.

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 19 May 2020.

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