- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05380258
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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
Keywords
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.
Clinical Trials on Labor Pain
-
Antalya Bilim UniversityCompletedChildbirth | Normal Labor | Labor Pain and to Reduce PainTurkey (Türkiye)
-
Pınar ErdoğanCompletedLabor Progress | Labor Pain and AnxietyTurkey (Türkiye)
-
Soovu Labs Inc.Virginia Mason Hospital/Medical CenterNot yet recruiting
-
Bogomolets National Medical UniversityCompleted
-
Cairo UniversityNot yet recruiting
-
Martin-Luther-Universität Halle-WittenbergCompleted
-
Maimonides Medical CenterTerminated
-
Roi TreisterHillel Yaffe Medical CenterNot yet recruitingLabor Pain and to Reduce PainIsrael
-
Aretaieio HospitalRecruitingLabor Pain | Pain, Labor | EpiduralGreece
Clinical Trials on chewing gum
-
Muttalip AyarCompletedAthletic PerformanceTurkey (Türkiye)
-
Denver Nephrologists, P.C.CM&D Pharma LimitedCompletedChronic Kidney Disease | HyperphosphatemiaUnited States
-
University of WashingtonBaylor College of Medicine; Baylor College of Medicine Children's FoundationRecruitingPeriodontitis | Gingivitis | Preterm Birth | Developmental Delay | Low Birthweight NeonateMalawi
-
Fenerbahce UniversityIstanbul University; Umraniye Education and Research HospitalNot yet recruitingPostoperative Nausea and Vomiting (PONV) | Intraperitoneal Chemotherapy | Peritoneal Metastases From Colorectal CancerTurkey (Türkiye)
-
Ege UniversityCompleted
-
Ahmed Salah Ahmed Abd ElgalilCompletedEndotracheal Intubation | Randomized Controlled Trial | Sore Throat | Gum ChewingEgypt
-
Instituto Tecnologico y de Estudios Superiores...Completed
-
Muş Alparslan UniversityCompletedPain ManagementTurkey (Türkiye)
-
Inha University HospitalBobath Memorial HospitalRecruiting
-
American University of Beirut Medical CenterRecruiting