The Effect of Chewing Gum and Use of Stress Balls on Perception of Labor Pain, Fear of Birth, and Duration of Delivery

March 3, 2023 updated by: Şahika ŞİMŞEK ÇETİNKAYA, Kastamonu University
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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kastamonu
      • Merkez, Kastamonu, Turkey, 37150
        • Şahika Şimşek Çetinkaya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: chewing gum
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.
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.
Experimental: stress ball
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.
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.
No Intervention: Control Group
standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
labor pain
Time Frame: 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
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
Time Frame: A birth follow-up form was used from the beginning of cervical dilatation to delivery.
A birth follow-up form was used from the beginning of cervical dilatation to delivery.
birth satisfaction
Time Frame: satisfaction form used postpartum at the 4th hour
satisfaction form used postpartum at the 4th hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2021

Primary Completion (Actual)

June 5, 2021

Study Completion (Actual)

June 5, 2022

Study Registration Dates

First Submitted

May 10, 2022

First Submitted That Met QC Criteria

May 14, 2022

First Posted (Actual)

May 18, 2022

Study Record Updates

Last Update Posted (Estimate)

March 6, 2023

Last Update Submitted That Met QC Criteria

March 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAEK-143-132

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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