The Effect of Using a Birth Ball and Squatting Position During Labor

Sponsor

Fatma Dünmez (Other)

Overall Status

Completed

CT.gov ID

NCT05360823

Collaborator

(none)

159

Enrollment

Location

Arms

11.7

Actual Duration (Months)

13.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study was to evaluate the effect of using the birth ball and squatting position during labor on labor pain, duration of labor and satisfaction. The research is a randomized controlled experimental study. The sample of the study consisted of a total of 159 pregnant women, 53 in the birthing ball application group, 53 in the squatting group, and 53 in the control group, who met the criteria for inclusion in the study.

Condition or Disease	Intervention/Treatment	Phase
Labor Pain Labor Fast Satisfaction, Patient	Other: Birth ball Other: Squatting	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

159 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

The Effect of Using a Birth Ball and Squatting Position During Labor on Labor Pain, Duration of Labor and Satisfaction

Actual Study Start Date :

Jul 3, 2021

Actual Primary Completion Date :

Jan 20, 2022

Actual Study Completion Date :

Jun 24, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Birth Ball Group In the active and transitional phases, during contractions, performing exercises on the birth ball (fully rotating the hip, moving to the right/left, coming back and forth, and slightly bouncing while sitting on the birth ball) (average 25 minutes). In order to monitor the condition of the fetus, exercises on the birth ball were performed by the pregnant woman during contractions while connected to NST.	Other: Birth ball Exercises for childbirth
Experimental: Squatting Group In the active and transitional phase, squatting position (squatting with feet shoulder-width apart by laying a clean sheet on the floor and getting support from a bed, chair or birth ball) during contractions (average 25 minutes). In order to monitor the condition of the fetus, the squatting position was used by the pregnant woman during contractions while connected to the NST.	Other: Squatting Exercises for childbirth
No Intervention: Control Group Usual routine care of the service.

Arm

Intervention/Treatment

Experimental: Birth Ball Group

In the active and transitional phases, during contractions, performing exercises on the birth ball (fully rotating the hip, moving to the right/left, coming back and forth, and slightly bouncing while sitting on the birth ball) (average 25 minutes). In order to monitor the condition of the fetus, exercises on the birth ball were performed by the pregnant woman during contractions while connected to NST.

Other: Birth ball

Exercises for childbirth

Experimental: Squatting Group

In the active and transitional phase, squatting position (squatting with feet shoulder-width apart by laying a clean sheet on the floor and getting support from a bed, chair or birth ball) during contractions (average 25 minutes). In order to monitor the condition of the fetus, the squatting position was used by the pregnant woman during contractions while connected to the NST.

Other: Squatting

Exercises for childbirth

No Intervention: Control Group

Usual routine care of the service.

Outcome Measures

Primary Outcome Measures

Personal and Obstetric Information Form [pre-intervention]
This form, prepared by the researcher, consists of 45 questions including sociodemographic, obstetric and obstetric follow-up information of women.
Visual Analog Scale (VAS) [latent, active and transition phase of labor]
It is a measuring instrument with a score between 0 (no pain) and 10 (severe pain), divided equally by marks on a horizontal or vertical 10 cm line. Horizontal form was used in the research. The scale was used to assess the severity of pain.
Partogram [active phase of labor]
It is a graphical form used to evaluate the progress of birth and the health status of the baby.
Evaluation Scale for Maternal Satisfaction with Normal Delivery [Postpartum at the 4th hour]
This is used to assess the mother's level of satisfaction at birth. The scale, which has a validity and reliability of 0.91 in Turkey, was developed by Güngör and Beji in 2009. It is a 5-point Likert-type scale consisting of 43 items and 10 sub-dimensions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

No risky pregnancy
Gestational week between 37-42
Unopened amniotic membrane
Those who will give birth vaginally
In active phase
Fluent in Turkish
Singleton pregnancy
Primiparous

Exclusion Criteria:

Any complication development
Cesarean section status

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul University-Cerrahpasa	Istanbul		Turkey

Sponsors and Collaborators

Fatma Dünmez

Investigators

Principal Investigator: Fatma Dünmez, Midwife, Istanbul University-Cerrahpasa

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Ministry of Health Partograph Circular

Publications

Responsible Party:

Fatma Dünmez, Midwifery-Master Student, Istanbul University-Cerrahpasa

ClinicalTrials.gov Identifier:

NCT05360823

Other Study ID Numbers:

ISBASP

First Posted:

May 4, 2022

Last Update Posted:

Jul 28, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fatma Dünmez, Midwifery-Master Student, Istanbul University-Cerrahpasa

Additional relevant MeSH terms:

Labor Pain

Study Results

No Results Posted as of Jul 28, 2022