- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06959940
- Original Trial
Alternative Method: Chewing Gum in Labor
Alternative Method to Reduce Pain, Anxiety, Fatigue, and Thirst: Chewing Gum in Labor
This study is a clinical trial. It aimed to examine the effects of chewing gum on pain, anxiety, fatigue, and thirst in pregnant women (47 experiments; 47 controls) in the first stage of labor. Criteria for inclusion in the study: Pregnant women who gave birth vaginally; voluntarily accept to participate in the research. Exclusion criteria from the study: Pregnant women who have auditory or mental health problems; whose baby dies during labor, who with cervical dilatation of 5 cm or more, who receiving epidural anesthesia, do not like chewing gum, have difficulty chewing, such as weak/loose-fitting dentures. The pain, anxiety, fatigue, and thirst levels of the pregnant women in the control group were evaluated with scales every two hours until their dilatation reached 5 cm. Pregnant women in the experimental group chewed gum and their pain, anxiety, fatigue and thirst levels were evaluated with scales every two hours until their dilation reached 5 cm.
The main questions it aims to answer are:
- Chewing gum during labor is not effective in reducing pain, anxiety, fatigue, and thirst levels.
- Chewing gum during labor; It is effective in reducing the level of pain.
- Chewing gum during labor; It is effective in reducing anxiety.
- Chewing gum during labor; It is effective in reducing thirst.
- Chewing gum during labor; It is effective in reducing fatigue. Routine medical treatment of pregnant women continued all groups. Only pregnant women who in the experimental group chewed gum also.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objective: In this study, it was aimed to examine the effects of chewing gum on pain, anxiety, fatigue and thirst in pregnant women in the first stage of normal labor.
Methods: The study was conducted in a randomized controlled experimental manner. The universe consisted of all pregnant women who applied to the delivery room of a public institution between April and November 2022. Power analysis was used to determine the sample. 94 pregnant women (47 experiments;47 controls) were included in the study. The study was started after the approval of the ethics committee and the institution. As a data collection tool in the research;"Personal Information Form","Gum Chewing Follow-up Form" and "Pregnant Follow-up Form" were used.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Biruni University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Vaginal delivery,
- Who volunteered to participate in the research
Exclusion Criteria:
- Have auditory or mental health problems,
- The baby dies during labour,
- Cervical dilatation of 5 cm or more,
- Receiving epidural anaesthesia,
- People who don't like chewing gum,
- Chewing difficulties due to weak/loose prostheses
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: This research is planned with experimental design
After the pregnant woman in the control group was admitted to the delivery room, the data collection tools "Personal Information Form" and "Pregnant Follow-up Form" were applied.
Pregnancy Follow-up Form consists of pain, anxiety, fatigue and thirst scales.
The VAS pain, anxiety, fatigue, and thirst scales contains numbers evenly spaced (0-10) on a line.
It is an evaluation scale filled out by patients stating their current pain, anxiety, fatigue, and thirst level by giving a number.
The cut-off point of the VAS anxiety and thirst scales were found to be four.
In VAS anxiety, scores above this cut-off point indicate deviation from normal and individuals must be handled by professionals.
IN VAS thirst, patients who score above this score are considered to be experiencing dehydration symptoms.
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After the pregnant woman in the experimental group was admitted to the delivery room, the data collection tools "Personal Information Form" and "Pregnant Follow-up Form" were applied.
Pregnant women who agreed to participate in the study were given information about chewing gum.
Pain, anxiety, fatigue and thirst scales were administered to the pregnant woman before she started chewing gum.
The pregnant woman was allowed to chew gum for 15 minutes.
At the end of 15 minutes, the measurements were repeated.
Applications were repeated as stated above every two hours until the pregnant woman's dilation reached 5 cm.
Routine medical treatment of pregnant women continued.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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2
Time Frame: Anxiety scale used starting to chew gum. Then after chewing gum (immediately after the intervention), the scale was repeated. The score on the scale is between 0-10, just like the VAS (visual analogue pain scale). The higher score is the greater problem.
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Change from anxiety scale scores at control group or experimental group in during labor
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Anxiety scale used starting to chew gum. Then after chewing gum (immediately after the intervention), the scale was repeated. The score on the scale is between 0-10, just like the VAS (visual analogue pain scale). The higher score is the greater problem.
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1
Time Frame: Pain scale used starting to chew gum. Then after chewing gum (immediately after the intervention), the scale was repeated. The score on the scale is between 0-10, just like the VAS (visual analogue pain scale). The higher score is the greater problem.
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Change from pain scale scores at control group or experimental group in during labor
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Pain scale used starting to chew gum. Then after chewing gum (immediately after the intervention), the scale was repeated. The score on the scale is between 0-10, just like the VAS (visual analogue pain scale). The higher score is the greater problem.
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3
Time Frame: Fatigue scale used starting to chew gum. Then after chewing gum (immediately after the intervention), the scale was repeated. The score on the scale is between 0-10, just like the VAS (visual analogue pain scale). The higher score is the greater problem.
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Change from fatigue scale scores at control group or experimental group in during labor
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Fatigue scale used starting to chew gum. Then after chewing gum (immediately after the intervention), the scale was repeated. The score on the scale is between 0-10, just like the VAS (visual analogue pain scale). The higher score is the greater problem.
|
|
4
Time Frame: Thirst scale used starting to chew gum. Then after chewing gum (immediately after the intervention), the scale was repeated. The score on the scale is between 0-10, just like the VAS (visual analogue pain scale). The higher score is the greater problem.
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Change from thirst scale scores at control group or experimental group in during labor
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Thirst scale used starting to chew gum. Then after chewing gum (immediately after the intervention), the scale was repeated. The score on the scale is between 0-10, just like the VAS (visual analogue pain scale). The higher score is the greater problem.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Chewing gum in labor
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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