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

Primary Purpose

Labor Pain, Birth Satisfaction, Duration of Birth

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
stress ball
chewing gum
Sponsored by
Kastamonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Labor Pain focused on measuring chewing gum,, stress ball, labor pain, satisfaction

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Şahika Şimşek Çetinkaya

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

chewing gum

stress ball

Control Group

Arm Description

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 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.

standard care

Outcomes

Primary Outcome Measures

labor pain
Duration of labor
birth satisfaction

Secondary Outcome Measures

Full Information

First Posted
May 10, 2022
Last Updated
March 3, 2023
Sponsor
Kastamonu University
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1. Study Identification

Unique Protocol Identification Number
NCT05380258
Brief Title
The Effect of Chewing Gum and Use of Stress Balls on Perception of Labor Pain, Fear of Birth, and Duration of Delivery
Official Title
The Effect of Chewing Gum and Use of Stress Balls on Perception of Labor Pain, Fear of Birth, and Duration of Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 5, 2021 (Actual)
Primary Completion Date
June 5, 2021 (Actual)
Study Completion Date
June 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kastamonu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Birth Satisfaction, Duration of Birth
Keywords
chewing gum,, stress ball, labor pain, satisfaction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
chewing gum
Arm Type
Experimental
Arm Description
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.
Arm Title
stress ball
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
standard care
Intervention Type
Other
Intervention Name(s)
stress ball
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
chewing gum
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
Duration of labor
Time Frame
A birth follow-up form was used from the beginning of cervical dilatation to delivery.
Title
birth satisfaction
Time Frame
satisfaction form used postpartum at the 4th hour

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Şahika Şimşek Çetinkaya
City
Merkez
State/Province
Kastamonu
ZIP/Postal Code
37150
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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