The Use of Peanut Ball in Labor in Obese Women

Sponsor
Gulhane Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05276947
Collaborator
(none)
80
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2
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Study Details

Study Description

Brief Summary

The purpose of this study is to assess the efficacy of peanut ball use on labor process and maternal, neonatal outcomes in obese pregnant women.

Condition or Disease Intervention/Treatment Phase
  • Other: position with peanut ball
N/A

Detailed Description

After being informed about the study, all participants giving written informed consent, on the active phase of labor (cervical dilatation = 5 cm), the pregnant women in the experimental group will be provided with a position change lasting at least 30 minutes every hour with a peanut ball. The peanut ball will be used with a sheath that is changed for each participant. Pregnant women in the control group will be included in the study during the active phase of labor (cervical dilatation = 5 cm). No intervention will be made by the researcher. They will receive standard care by the service nurse.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
There will be an intervention group and a control group.There will be an intervention group and a control group.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Peanut Ball Use on Labor Process and Maternal - Neonatal Outcomes in Obese Pregnants
Actual Study Start Date :
Mar 21, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Peanut ball intervention

The experimental group. In the active phase of the labor (cervical dilatation = 5 cm), the peanut ball, which has a cover provided by the researcher and changed in each patient, will be placed between the knees of the participant for at least 30 minutes every hour, and a position change will be provided with the peanut ball in each time. The positions to be given with the peanut ball, semi sitting lunge, side lying, tucked, leaning forward, pushing and sitting position.

Other: position with peanut ball
The experimental group will be positioned with the peanut ball until the end of the active phase of labor.

No Intervention: Control group

Standard care will be given to the control group without positioning with a peanut ball.

Outcome Measures

Primary Outcome Measures

  1. Labor time [From 5 cm of cervical dilatation to the second stage of labor]

    The primary outcome measure is the length of first stage (active phase) and second stage of labor in obese pregnant women.

Secondary Outcome Measures

  1. Pain level [Latent phase, active phase and at cervical dilatation 10 cm (on contractions)]

    Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically. Two end definitions of the parameter to be evaluated are written at the two ends of a 10 cm line, and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing. For example, for pain, I have no pain at one end and very severe pain at the other end and the patient marks his/her current state on this line. The length of the distance from the point where there is no pain to the point marked by the patient indicates the patient's pain (0: no pain 10: severe pain)

  2. Operative vaginal delivery rate [From 5 cm of cervical dilatation to the expulsion phase of labor]

    Forceps/vacuum

  3. Type of delivery [From 5 cm of cervical dilatation to the expulsion phase of labor]

    Cesarean section or vaginal delivery

  4. Maternal complications [From 5 cm of cervical dilatation to the expulsion phase of labor]

    Perineal laceration and atony

  5. Neonatal complications [From 5 cm of cervical dilatation to the expulsion phase of labor]

    APGAR score, need for neonatal intensive care. For the Apgar score, five symptoms are checked, including respiration, heart rate, color, tone, and response to stimuli. Each symptom is scored as 0, 1, or 2. The baby is scored as '0' if there is no breathing or heartbeat, his color is pale or cyanotic, his tone is loose, and he does not respond to the stimulus given by inserting the catheter into the nose.

  6. Birth satisfaction [Postpartum first hour]

    Birth Satisfaction Scale A minimum of 30 and a maximum of 150 points are obtained from the scale. The higher the score, the higher the level of satisfaction.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Admitted for delivery

  • Maternal BMI > 30kg/m2 at admission

  • Gestational age > 37 weeks 0 days

  • Singleton pregnancy

  • Cephalic presentation

  • Cervical dilatation less than 5 cm

  • Turkish speaking

Exclusion Criteria:
  • Pre-pregnancy BMI < 30kg/m2

  • Gestational age < 37 weeks 0 days

  • Multifetal gestation

  • Intrauterine fetal demise

  • Musculoskeletal problems

  • Receiving magnesium sulfate

  • High risk pregnancies (Preeclampsia/eclampsia, cholestasis, intrauterine growth retardation, fetal anomaly, polyhydramnios or oligohydramnios)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gulhane Training and Research Hospital Ankara Turkey

Sponsors and Collaborators

  • Gulhane Training and Research Hospital

Investigators

  • Study Director: Gulten GUVENC, PhD, RN, Gulhane Faculty of Nursing, University of Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fulden Ozkececi, Principal Investigator, Gulhane Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT05276947
Other Study ID Numbers:
  • PBinON
First Posted:
Mar 14, 2022
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fulden Ozkececi, Principal Investigator, Gulhane Training and Research Hospital

Study Results

No Results Posted as of Aug 3, 2022