NCT04393870

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

9 months

First QC Date

May 11, 2020

Last Update Submit

May 18, 2020

Conditions

Keywords

comfort at laborlabor painMaryam's flowerfocused attentionbirth satisfaction

Outcome Measures

Primary Outcomes (3)

  • 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

    immediately after the intervention

  • 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)

    during the procedure

  • 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

    immediately after the intervention

Secondary Outcomes (1)

  • birth satisfaction level.

    2nd hour of the postnatal period.

Study Arms (2)

Maryam's Flower Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

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

Maryam's Flower Group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hülya TÜRKMEN

Balıkesir, 10100, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Labor PainPersonal Satisfaction

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer (PhD)

Study Record Dates

First Submitted

May 11, 2020

First Posted

May 19, 2020

Study Start

May 1, 2019

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

May 19, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations