NCT05380258

Brief Summary

This study was conducted as a randomized controlled experimental study. This study was planned to determine the effects of chewing gum and using a stress ball on the perception of labor pain, duration of labor and birth satisfaction. The population of the study consisted of primiparous mothers who applied to the hospital. This study was planned to determine the effects of chewing gum and using a stress ball on the perception of labor pain, duration of labor and birth satisfaction. The study was carried out in two stages. In the first stage, the data were collected in the delivery room, and in the second stage, the postpartum satisfaction levels of the mothers were measured in the postpartum service. The sample number of the investigators' study was determined as 96. Visual analog scale, birth satisfaction scale and birth follow-up form were used for the data of our study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2022

Completed
Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

1 month

First QC Date

May 10, 2022

Last Update Submit

March 3, 2023

Conditions

Keywords

chewing gum,stress balllabor painsatisfaction

Outcome Measures

Primary Outcomes (3)

  • labor pain

    Visual Analog scale I for labor pain was applied in 0-3 cm , Visual Analog Scale II in 4-5 cm and Visual Analog Scale III was applied in 6-8 cm cervical dilatation. The study continues through study completion, an average of 1 year

  • Duration of labor

    A birth follow-up form was used from the beginning of cervical dilatation to delivery.

  • birth satisfaction

    satisfaction form used postpartum at the 4th hour

Study Arms (3)

chewing gum

EXPERIMENTAL

Pregnant women with 4-5 cm cervical dilatation started chewing gum as soon as their contractions came and they chewed gum for 20 minutes. and when the cervical dilation was 6-8 cm, they chewed gum again for 20 minutes.

Other: chewing gum

stress ball

EXPERIMENTAL

Pregnant women with 4-5 cm cervical dilatation were asked to tighten the ball for 5 seconds and relax for 2 seconds within 20 minutes when their contractions came, and when the cervical opening was 6-8 cm, they were asked to tighten the ball for 5 seconds and relax for 2 seconds within 20 minutes.

Other: stress ball

Control Group

NO INTERVENTION

standard care

Interventions

Pregnant women with 4-5 cm cervical dilatation were asked to tighten the ball for 5 seconds and relax for 2 seconds within 20 minutes when their contractions came, and when the cervical opening was 6-8 cm, they were asked to tighten the ball for 5 seconds and relax for 2 seconds within 20 minutes.

stress ball

Pregnant women with 4-5 cm cervical dilatation were asked to squeeze the ball for 5 seconds and loosen it for 2 seconds as soon as their contractions came and within 20 minutes, and when the cervical opening was 6-8 cm, they chewed gum again for 20 minutes.

chewing gum

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being primiparous to be in due time
  • To have spontaneous vaginal delivery
  • Ability to communicate verbally be between the ages of 18-35
  • Not having a risky pregnancy
  • Having a single fetus in the vertex position
  • Having started contractions and continuing regularly
  • Being in the latent phase of action (0-4 cm dilatation)
  • Not having used any analgesia or using any pain medication to reduce pain during labor

You may not qualify if:

  • Mothers who have a cesarean section decision
  • Risky Pregnant
  • Multiple Pregnancies
  • Multiparous pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Şahika Şimşek Çetinkaya

Merkez, Kastamonu, 37150, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor PainPersonal Satisfaction

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex MixturesCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Şahika ŞİMŞEK ÇETİNKAYA

Study Record Dates

First Submitted

May 10, 2022

First Posted

May 18, 2022

Study Start

May 5, 2021

Primary Completion

June 5, 2021

Study Completion

June 5, 2022

Last Updated

March 6, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations