MothersNCT05945095
The Effect of Chewing Gum After Cesarean Section on Gastrointestinal System Functions, Pain and Sleep Quality
A study testing Gum chewing group in people with Mothers and Cesarean Section Complications, run by Artvin Coruh University at 1 site in Turkey (Türkiye).
Trial summary
The study will be conducted on mothers who had planned cesarean section.After the birth, the information about the surgery in the personal information form will be completed. Then, mothers in the control group will be given standard postpartum care. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mothers, Cesarean Section Complications
- What is being tested?
- Gum chewing group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Mar 2023to 20 May 2024
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be eighteen years of age or older,
- Having a planned cesarean section,
- To receive general anesthesia in the surgery,
- No history of chronic constipation and diarrhea,
- At least primary school graduate
- Communication is not a problem.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Artvin State Hospital
Artvin, 08000
Dilek KALOĞLU BİNİCİ, PhD, 5058110022, dkaloglu@artvin.edu.tr
Enes BULUT, PhD, 5464213863, bulutts61@artvin.edu.tr
About this study
The study will be conducted on mothers who had planned cesarean section.After the birth, the information about the surgery in the personal information form will be completed. Then, mothers in the control group will be given standard postpartum care. The mothers in the experimental group, on the other hand, will chew sugar-free gum for at least 15 minutes, starting from the second hour after the surgery. The gum chewing process will be repeated every two hours. Mothers will be mobilized at the 8th sat after the birthday.
Pain levels of mothers in both groups will be evaluated every two hours after delivery.
In addition, the amount of analgesic use will be compared and comments will be made on the level of pain. The sleep quality of the postpartum women will be questioned the day after the cesarean section.
Read the detailed description
The study will be conducted on mothers who had planned cesarean section. The sample size in similar studies was examined and it was determined that at least 30 mothers should be included in the experimental and control groups.
Assignment of pregnant women to the experimental and control groups will be made using a simple random numbers table.
In the data collection process of the research, the "personal information form" consisting of 24 questions and developed by the researchers as a result of the literature review, the "Richard-Campbell Sleep Scale" and the "Visual Comparison Scale (VAS)" will be used.
Prenatal interviews will be conducted with the pregnant women and their status of meeting the following inclusion criteria will be evaluated, and all pregnant women who comply with the criteria and agree to participate in the study will be asked questions regarding the prenatal period in the personal information form.
After the birth, the information about the surgery in the personal information form will be completed.
Then, mothers in the control group will be given standard postpartum care. The mothers in the experimental group, on the other hand, will chew sugar-free gum for at least 15 minutes, starting from the second hour after the surgery.
The gum chewing process will be repeated every two hours. Mothers will be mobilized at the 8th sat after the birthday. Pain levels of mothers in both groups will be evaluated every two hours after delivery.
In addition, the amount of analgesic use will be compared and comments will be made on the level of pain.
The sleep quality of the postpartum women will be questioned the day after the cesarean section.
Gastrointestinal system functions will be followed in the postoperative period and will be evaluated by asking questions about gas output and defecation time in the personal information form.
After the mothers in both groups have defecated, the data collection process will be completed from the mother concerned.
The data obtained will be entered into the SPSS (Statistical Package for the Social Sciences) 22.0 package program and evaluated with appropriate statistical analysis.
Inclusion Criteria for Research:
be 18 years or older, having a planned cesarean section, to receive general anesthesia during surgery, chronic constipation and no history of diarrhea be at least a primary school graduate, and is not a communication problem.
- Conditions
- Mothers, Cesarean Section Complications
- Being tested
- Gum chewing group
- Keywords
- General anesthesia,, Sleep Quality, Chewing Gum, Pain,, Cesarean section,
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gum chewing groupOther
The mothers in the experimental group, on the other hand, will chew sugar-free gum for at least 15 minutes, starting from the second hour after the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Gum chewing group Receives: Other: Gum chewing group |
| Control group | No intervention | Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
VAS is used to measure perceived pain. VAS is a 10cm line with anchor statements on lower end (no pain) and on upper end (extreme pain). The mother is asked to mark their current pain level on the line
Measured: "change" is being assessed. up to 10-12 hours after cesarean section
Secondary outcomes (1)
Richard-Campbell Sleep Scale (RCUI)
The Turkish validity and reliability study of the scale, which was developed by Richards in 1987, was carried out by Özlü and Özer in 2015.
Each item of the six-item scale, which evaluates the depth of night sleep, the duration of falling asleep, the frequency of awakening, the time to stay awake when awakened, the quality of sleep and the noise level in the environment, is evaluated on a chart between 0-100 using the visual analog scale technique.
A score of "0-25" from the scale indicates very bad sleep, and a score of "76-100" indicates very good sleep.
The total score of the scale is evaluated over 5 items, and the sixth item, which evaluates the noise level in the environment, is excluded from the total score evaluation.
As the score of the scale increases, the sleep quality of the patients also increases.
The Cronbach's alpha value of the scale is 0.91.
Measured: in the morning the day after the cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start27 Mar 2023
- Primary completion27 Dec 2023 (estimated)
- Study completion20 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MothersStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The sample size in similar studies was examined and it was determined that at least 30 mothers should be included in the experimental and control groups. Assignment of pregnant women to the experimental and control groups will be made using a simple random numbers table.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Artvin Coruh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Kaloglu Binici, Artvin Coruh University
- Investigators
- Dilek KALOĞLU BİNİCİ, PhD, Principal investigator, Artvin Coruh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945095
- Sponsor's protocol ID
- Gum after cesarean section
- Status last verified
- Jul 2023
- First submitted
- 5 Apr 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pereira Gomes Morais E, Riera R, Porfirio GJ, Macedo CR, Sarmento Vasconcelos V, de Souza Pedrosa A, Torloni MR. Chewing gum for enhancing early recovery of bowel function after caesarean section. Cochrane Database Syst Rev. 2016 Oct 17;10(10):CD011562. doi: 10.1002/14651858.CD011562.pub2.
PubMed 27747876
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chewing Gum After Cesarean Section on Gastrointestinal System Functions, Pain and Sleep Quality
- ClinicalTrials.gov ID
- NCT05945095
- Acronym / sponsor ID
- Gum after cesarean section
- Conditions
- Mothers, Cesarean Section Complications
- Keywords
- General anesthesia,, Sleep Quality, Chewing Gum, Pain,, Cesarean section,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Artvin Coruh UniversityUniversity, hospital or other
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 27 Dec 2023 (estimated)
- Study completion
- 20 May 2024 (estimated)
- First posted
- 14 Jul 2023 (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.
The study will be conducted on mothers who had planned cesarean section.After the birth, the information about the surgery in the personal information form will be completed. Then, mothers in the control group will be given standard postpartum care. The mothers in the experimental group, on the other hand, will chew sugar-free gum for at least 15 minutes, starting from the second hour after the surgery. The gum chewing process will be repeated every two hours. Mothers will be mobilized at the 8th sat after the birthday.
Pain levels of mothers in both groups will be evaluated every two hours after delivery.
In addition, the amount of analgesic use will be compared and comments will be made on the level of pain. The sleep quality of the postpartum women will be questioned the day after the cesarean section.
Detailed description
The study will be conducted on mothers who had planned cesarean section. The sample size in similar studies was examined and it was determined that at least 30 mothers should be included in the experimental and control groups.
Assignment of pregnant women to the experimental and control groups will be made using a simple random numbers table.
In the data collection process of the research, the "personal information form" consisting of 24 questions and developed by the researchers as a result of the literature review, the "Richard-Campbell Sleep Scale" and the "Visual Comparison Scale (VAS)" will be used.
Prenatal interviews will be conducted with the pregnant women and their status of meeting the following inclusion criteria will be evaluated, and all pregnant women who comply with the criteria and agree to participate in the study will be asked questions regarding the prenatal period in the personal information form.
After the birth, the information about the surgery in the personal information form will be completed.
Then, mothers in the control group will be given standard postpartum care. The mothers in the experimental group, on the other hand, will chew sugar-free gum for at least 15 minutes, starting from the second hour after the surgery.
The gum chewing process will be repeated every two hours. Mothers will be mobilized at the 8th sat after the birthday. Pain levels of mothers in both groups will be evaluated every two hours after delivery.
In addition, the amount of analgesic use will be compared and comments will be made on the level of pain.
The sleep quality of the postpartum women will be questioned the day after the cesarean section.
Gastrointestinal system functions will be followed in the postoperative period and will be evaluated by asking questions about gas output and defecation time in the personal information form.
After the mothers in both groups have defecated, the data collection process will be completed from the mother concerned.
The data obtained will be entered into the SPSS (Statistical Package for the Social Sciences) 22.0 package program and evaluated with appropriate statistical analysis.
Inclusion Criteria for Research:
be 18 years or older, having a planned cesarean section, to receive general anesthesia during surgery, chronic constipation and no history of diarrhea be at least a primary school graduate, and is not a communication problem.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The sample size in similar studies was examined and it was determined that at least 30 mothers should be included in the experimental and control groups. Assignment of pregnant women to the experimental and control groups will be made using a simple random numbers table.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Gum chewing groupGum chewing group |
| Control group | No intervention | –Routine care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be eighteen years of age or older,
- Having a planned cesarean section,
- To receive general anesthesia in the surgery,
- No history of chronic constipation and diarrhea,
- At least primary school graduate
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Gum chewing groupThe mothers in the experimental group, on the other hand, will chew sugar-free gum for at least 15 minutes, starting from the second hour after the surgery. | Other | Experimental group |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: "change" is being assessed. up to 10-12 hours after cesarean section
VAS is used to measure perceived pain. VAS is a 10cm line with anchor statements on lower end (no pain) and on upper end (extreme pain). The mother is asked to mark their current pain level on the line
1 secondary outcome
Richard-Campbell Sleep Scale (RCUI)
Time frame: in the morning the day after the cesarean section
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Results publication: PubMed 27747876Pereira Gomes Morais E, Riera R, Porfirio GJ, Macedo CR, Sarmento Vasconcelos V, de Souza Pedrosa A, Torloni MR. Chewing gum for enhancing early recovery of bowel function after caesarean section. Cochrane Database Syst Rev. 2016 Oct 17;10(10):CD011562. doi: 10.1002/14651858.CD011562.pub2.
- Individual participant dataSharing planned: No
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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.
Dilek KALOĞLU BİNİCİ, PhD principal investigator
Artvin Coruh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gum chewing group in people with Mothers and Cesarean Section Complications, run by Artvin Coruh 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 6 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 14 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dilek KALOĞLU BİNİCİ, PhD (5058110022, dkaloglu@artvin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: "change" is being assessed. up to 10-12 hours after cesarean section). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05945095, which also lists 1 linked publication.
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 14 Jul 2023.