Labor PainNCT06959940
Alternative Method: Chewing Gum in Labor
A study testing experimental group (gum group) in people with Labor Pain, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- experimental group (gum group)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Vaginal delivery,
- Who volunteered to participate in the research
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Labor Pain
- Being tested
- experimental group (gum group)
- Keywords
- Labor, gum, pain, anxiety, fatigue, thirst
- Medical subject headings
- Labor Pain, Pain, Anxiety Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental group (gum group)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| This research is planned with experimental design | Experimental | 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. Receives: Other: experimental group (gum group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
2
Change from anxiety scale scores at control group or experimental group in during labor
Measured: 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.
1
Change from pain scale scores at control group or experimental group in during labor
Measured: 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.
3
Change from fatigue scale scores at control group or experimental group in during labor
Measured: 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
Change from thirst scale scores at control group or experimental group in during labor
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start1 Apr 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Power analysis was used to determine the sample. The power of the test was calculated with the G\*Power 3.1 program. The effect size in the interventional study conducted by Gundogdu (2019) on pregnant women was based on 0.932. In order to exceed the 95% value in determining the power of the study, it was determined that 94 people, including at least 47 people in the groups, should be reached the 5% significance level and 0.95 effect size (df=0.75; t=1.676).
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilgun Avci, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959940
- Sponsor's protocol ID
- Chewing gum in labor
- Status last verified
- Nov 2023
- First submitted
- 13 Nov 2023
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternative Method to Reduce Pain, Anxiety, Fatigue, and Thirst: Chewing Gum in Labor
- ClinicalTrials.gov ID
- NCT06959940
- Acronym / sponsor ID
- Chewing gum in labor
- Conditions
- Labor Pain
- Keywords
- Labor, gum, pain, anxiety, fatigue, thirst
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Power analysis was used to determine the sample. The power of the test was calculated with the G*Power 3.1 program. The effect size in the interventional study conducted by Gundogdu (2019) on pregnant women was based on 0.932. In order to exceed the 95% value in determining the power of the study, it was determined that 94 people, including at least 47 people in the groups, should be reached the 5% significance level and 0.95 effect size (df=0.75; t=1.676).
| Arm | Type | Receives |
|---|---|---|
| This research is planned with experimental design | Experimental | Other: experimental group (gum group)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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Vaginal delivery,
- Who volunteered to participate in the research
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| experimental group (gum group)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. | Other | This research is planned with experimental design |
Primary outcome
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.
Change from anxiety scale scores at control group or experimental group in during labor
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.
Change from pain scale scores at control group or experimental group in during labor
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.
Change from fatigue scale scores at control group or experimental group in during labor
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.
Change from thirst scale scores at control group or experimental group in during labor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental group (gum group) in people with Labor Pain, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.