Bowel IleusNCT06403215
Effect of Chewing Gum and Drinking Fennel Tea
A study testing Chewing gum group, Fennel tea group and Chewing gum+Fennel tea group in people with Bowel Ileus and Cesarean Section Complications, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Aim: Postoperative ileus after cesarean section is a problem that significantly prolongs hospital stay and increases perioperative costs. The ability of postoperative fennel tea consumption to produce bowel movement is unclear and needs to be studied. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bowel Ileus, Cesarean Section Complications
- What is being tested?
- Chewing gum group, Fennel tea group and Chewing gum+Fennel tea group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Sep 2017to 30 Jun 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Without chronic disease
- women who had a cesarean section under general anesthesia
- received primary school education at least
- women had no problems during pregnancy
- who had no history of allergy
- who had a body mass index (BMI) of 18.50-24.99 kg/m2
- no previous abdominal operation
- no complications during the operation.
Who cannot join
- age<18 years
- multiparous women
- who had a cesarean section under spinal anesthesia
- spontaneous onset of labor
- who had a chronic systemic disease
- who had problems during pregnancy
Show all 9Show fewer
- who had any history of allergy
- who had a body mass index (BMI) of <24.99 kg/m2
- who had a previous abdominal operation, and complications during the operation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Chewing Gum and Drinking Fennel Tea on Intestinal Motility After Cesarean Section: A Randomised Controlled Trial
Aim: Postoperative ileus after cesarean section is a problem that significantly prolongs hospital stay and increases perioperative costs. The ability of postoperative fennel tea consumption to produce bowel movement is unclear and needs to be studied. This study aimed to determine the effect of chewing gum and drinking fennel tea on intestinal motility after cesarean section.
Methods: The study was conducted in postnatal care wards between January 2018 and April 2018. Simple randomization was used to assign women to the study arms. Data were collected during Pregnancy Constipation Diagnostic Scale, Data Collection and Follow-up Form were collected.
Read the detailed description
Study Sample This parallel, monocenter, randomized controlled experimental study was conducted between January 2018 and April 2018 with the CONSORT guidelines in four maternity units in Türkiye. Inclusion criteria for the study were as follows: Healthy, women who had a cesarean section under general anesthesia, received primary school education at least, did not have a chronic systemic disease, had no problems during pregnancy, had no history of allergy, had a body mass index (BMI) of 18.50-24.99 kg/m2, with no previous abdominal operation, and no complications during the operation.
Participants and Setting After being included in the study, the women were registered as a participant and the study was carried out using opaque sealed envelopes numbered sequentially. The study was carried out with four different groups determined by 22 factorial trial levels. The sample size was determined as a total of 120 participants at 80% power and 95% confidence interval in consideration of the meta-analysis conducted on the data of the subjects. Two different interventions- chewing gum and drinking fennel tea - were conducted in this study.
Intervention Chewing gum group Women in this group chewed sugar-free and non-xylite gum for 15 minutes every two hours (2nd, 4th, and 6th) following the cesarean operation. As a result of their meta-analysis study, a study reported that chewing gum for 15 minutes every two hours until oral intake started bowel sounds in a shorter time. Therefore, in the current study, women chewed gum for 15 minutes every two hours, following two hours after the cesarean operation. The bowel sounds of the women were listened to and their flatulation times were recorded before and after gum chewing for 15 minutes every two hours. When women were allowed oral intake, gum-chewing activity was terminated completely. Data for the first time of flatulation and the bowel sounds were collected by verbally asking women, and these data were recorded in the follow-up form.
Fennel tea group Women in this group started oral intake 6 hours after cesarean delivery and were allowed to drink 2 grams of fennel tea in the 6th, 8th, and 10th hours (a total of 6 grams of fennel tea). Fennel seeds (2 grams) were put into 150 ml water, boiled at a temperature of 100 °C, and left for 20 minutes. Women were then instructed to drink the tea. Bowel sounds were recorded every 2 hours, before and after drinking the fennel tea. The time of the first flatulation and the first bowel sounds were determined by asking the women themselves and this information was then recorded using the study form.
Data collection The amount of fluid taken by the patients was measured with a glass. The amount of urine removed was calculated by checking the patient's bladder. The urinary catheter was removed at the 6th hour.
Ethical Statement The study was conducted in accordance with the Declaration of Helsinki and were approved by Ethics Committees (Protocol No: 09.2017.586). All patients signed informed consents.
Data Analysis Chi-square and Fisher tests were used to compare categorical data. Spearman's rank correlation coefficient was used to analyze and compare the statistical data. A value of p<0.05 was accepted for the statistical significance of the comparisons.
- Conditions
- Bowel Ileus, Cesarean Section Complications
- Being tested
- Chewing gum group, Fennel tea group, Chewing gum+Fennel tea group, Control group
- Keywords
- Cesarean, chewing gum, fennel tea, Bowel sounds
- Medical subject headings
- Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing gum groupOther
Women in this group chewed sugar-free and non-xylite gum for 15 minutes every two hours (2nd, 4th, and 6th) following the cesarean operation.
Fennel tea groupOther
Women in this group started oral intake 6 hours after cesarean delivery and were allowed to drink 2 grams of fennel tea in the 6th, 8th, and 10th hours (a total of 6 grams of fennel tea).
Chewing gum+Fennel tea groupOther
Women in this group both chewed sugar-free and non-xylite gum for 15 minutes every two hours (2nd, 4th, and 6th) following the cesarean operation and started oral intake 6 hours after cesarean delivery and were allowed to drink 2 grams of fennel tea in the 6th, 8th, and 10th hours (a total of 6 grams of fennel tea).
Control groupOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Chewing gum group | Experimental | Women in this group chewed sugar-free and non-xylite gum for 15 minutes every two hours (2nd, 4th, and 6th) following the cesarean operation. As a result of their meta-analysis study, a study reported that chewing gum for 15 minutes every two hours until oral intake started bowel sounds in a shorter time. Therefore, in the current study, women chewed gum for 15 minutes every two hours, following two hours after the cesarean operation. The bowel sounds of the women were listened to and their flatulation times were recorded before and after gum chewing for 15 minutes every two hours. When women were allowed oral intake, gum-chewing activity was terminated completely. Data for the first time of flatulation and the bowel sounds were collected by verbally asking women, and these data were recorded in the follow-up form. Receives: Other: Chewing gum group |
| Fennel tea group | Experimental | Women in this group started oral intake 6 hours after cesarean delivery and were allowed to drink 2 grams of fennel tea in the 6th, 8th, and 10th hours (a total of 6 grams of fennel tea). Fennel seeds (2 grams) were put into 150 ml water, boiled at a temperature of 100 °C, and left for 20 minutes. Women were then instructed to drink the tea. Bowel sounds were recorded every 2 hours, before and after drinking the fennel tea. The time of the first flatulation and the first bowel sounds were determined by asking the women themselves and this information was then recorded using the study form. Receives: Other: Fennel tea group |
| Chewing gum+Fennel tea group | Experimental | Women in this group chewed sugar-free and non-xylite gum for 15 minutes every two hours (2nd, 4th, and 6th) following the cesarean operation. As a result of their meta-analysis study, a study reported that chewing gum for 15 minutes every two hours until oral intake started bowel sounds in a shorter time.Women were then instructed to drink the tea. Bowel sounds were recorded every 2 hours, before and after drinking the fennel tea. The time of the first flatulation and the first bowel sounds were determined by asking the women themselves and this information was then recorded using the study form. Receives: Other: Chewing gum+Fennel tea group |
| Control group | Experimental | Researcher sounded in bowel movement as hospital protocols. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
bowel sounds
Bowel sounds were recorded every 2 hours.
Measured: 12 hours
flatulation
.The time of the first flatulation were determined by asking the women themselves and this information was then recorded using the study form.
Measured: 24 hours
defecation
.The time of the first defecation were determined by asking the women themselves and this information was then recorded using the study form.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start11 Sep 2017
- Primary completion30 Apr 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel IleusStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurdan Demirci, Marmara University
- Investigators
- Rüveyda Ölmez Yalazı, PhDc, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403215
- Sponsor's protocol ID
- 2018.2018
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chewing Gum and Drinking Fennel Tea on Intestinal Motility After Cesarean Section: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06403215
- Acronym / sponsor ID
- 2018.2018
- Conditions
- Bowel Ileus, Cesarean Section Complications
- Keywords
- Cesarean, chewing gum, fennel tea, Bowel sounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 7 May 2024 (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.
Aim: Postoperative ileus after cesarean section is a problem that significantly prolongs hospital stay and increases perioperative costs. The ability of postoperative fennel tea consumption to produce bowel movement is unclear and needs to be studied. This study aimed to determine the effect of chewing gum and drinking fennel tea on intestinal motility after cesarean section.
Methods: The study was conducted in postnatal care wards between January 2018 and April 2018. Simple randomization was used to assign women to the study arms. Data were collected during Pregnancy Constipation Diagnostic Scale, Data Collection and Follow-up Form were collected.
Detailed description
Study Sample This parallel, monocenter, randomized controlled experimental study was conducted between January 2018 and April 2018 with the CONSORT guidelines in four maternity units in Türkiye. Inclusion criteria for the study were as follows: Healthy, women who had a cesarean section under general anesthesia, received primary school education at least, did not have a chronic systemic disease, had no problems during pregnancy, had no history of allergy, had a body mass index (BMI) of 18.50-24.99 kg/m2, with no previous abdominal operation, and no complications during the operation.
Participants and Setting After being included in the study, the women were registered as a participant and the study was carried out using opaque sealed envelopes numbered sequentially. The study was carried out with four different groups determined by 22 factorial trial levels. The sample size was determined as a total of 120 participants at 80% power and 95% confidence interval in consideration of the meta-analysis conducted on the data of the subjects. Two different interventions- chewing gum and drinking fennel tea - were conducted in this study.
Intervention Chewing gum group Women in this group chewed sugar-free and non-xylite gum for 15 minutes every two hours (2nd, 4th, and 6th) following the cesarean operation. As a result of their meta-analysis study, a study reported that chewing gum for 15 minutes every two hours until oral intake started bowel sounds in a shorter time. Therefore, in the current study, women chewed gum for 15 minutes every two hours, following two hours after the cesarean operation. The bowel sounds of the women were listened to and their flatulation times were recorded before and after gum chewing for 15 minutes every two hours. When women were allowed oral intake, gum-chewing activity was terminated completely. Data for the first time of flatulation and the bowel sounds were collected by verbally asking women, and these data were recorded in the follow-up form.
Fennel tea group Women in this group started oral intake 6 hours after cesarean delivery and were allowed to drink 2 grams of fennel tea in the 6th, 8th, and 10th hours (a total of 6 grams of fennel tea). Fennel seeds (2 grams) were put into 150 ml water, boiled at a temperature of 100 °C, and left for 20 minutes. Women were then instructed to drink the tea. Bowel sounds were recorded every 2 hours, before and after drinking the fennel tea. The time of the first flatulation and the first bowel sounds were determined by asking the women themselves and this information was then recorded using the study form.
Data collection The amount of fluid taken by the patients was measured with a glass. The amount of urine removed was calculated by checking the patient's bladder. The urinary catheter was removed at the 6th hour.
Ethical Statement The study was conducted in accordance with the Declaration of Helsinki and were approved by Ethics Committees (Protocol No: 09.2017.586). All patients signed informed consents.
Data Analysis Chi-square and Fisher tests were used to compare categorical data. Spearman's rank correlation coefficient was used to analyze and compare the statistical data. A value of p<0.05 was accepted for the statistical significance of the comparisons.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chewing gum group | Experimental | Other: Chewing gum groupWomen in this group chewed sugar-free and non-xylite gum for 15 minutes every two hours (2nd, 4th, and 6th) following the cesarean operation. As a result of their meta-analysis study, a study reported that chewing gum for 15 minutes every two hours until oral intake started bowel sounds in a shorter time. Therefore, in the current study, women chewed gum for 15 minutes every two hours, following two hours after the cesarean operation. The bowel sounds of the women were listened to and their flatulation times were recorded before and after gum chewing for 15 minutes every two hours. When women were allowed oral intake, gum-chewing activity was terminated completely. Data for the first time of flatulation and the bowel sounds were collected by verbally asking women, and these data were recorded in the follow-up form. |
| Fennel tea group | Experimental | Other: Fennel tea groupWomen in this group started oral intake 6 hours after cesarean delivery and were allowed to drink 2 grams of fennel tea in the 6th, 8th, and 10th hours (a total of 6 grams of fennel tea). Fennel seeds (2 grams) were put into 150 ml water, boiled at a temperature of 100 °C, and left for 20 minutes. Women were then instructed to drink the tea. Bowel sounds were recorded every 2 hours, before and after drinking the fennel tea. The time of the first flatulation and the first bowel sounds were determined by asking the women themselves and this information was then recorded using the study form. |
| Chewing gum+Fennel tea group | Experimental | Other: Chewing gum+Fennel tea groupWomen in this group chewed sugar-free and non-xylite gum for 15 minutes every two hours (2nd, 4th, and 6th) following the cesarean operation. As a result of their meta-analysis study, a study reported that chewing gum for 15 minutes every two hours until oral intake started bowel sounds in a shorter time.Women were then instructed to drink the tea. Bowel sounds were recorded every 2 hours, before and after drinking the fennel tea. The time of the first flatulation and the first bowel sounds were determined by asking the women themselves and this information was then recorded using the study form. |
| Control group | Experimental | Other: Control groupResearcher sounded in bowel movement as hospital protocols. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Without chronic disease
- women who had a cesarean section under general anesthesia
- received primary school education at least
- women had no problems during pregnancy
- who had no history of allergy
Key exclusion criteria (9 listed)
- age<18 years
- multiparous women
- who had a cesarean section under spinal anesthesia
- spontaneous onset of labor
- who had a chronic systemic disease
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 |
|---|---|---|
| Chewing gum groupWomen in this group chewed sugar-free and non-xylite gum for 15 minutes every two hours (2nd, 4th, and 6th) following the cesarean operation. | Other | Chewing gum group |
| Fennel tea groupWomen in this group started oral intake 6 hours after cesarean delivery and were allowed to drink 2 grams of fennel tea in the 6th, 8th, and 10th hours (a total of 6 grams of fennel tea). | Other | Fennel tea group |
| Chewing gum+Fennel tea groupWomen in this group both chewed sugar-free and non-xylite gum for 15 minutes every two hours (2nd, 4th, and 6th) following the cesarean operation and started oral intake 6 hours after cesarean delivery and were allowed to drink 2 grams of fennel tea in the 6th, 8th, and 10th hours (a total of 6 grams of fennel tea). | Other | Chewing gum+Fennel tea group |
| Control groupNo intervention | Other | Control group |
Primary outcome
bowel sounds
Time frame: 12 hours
Bowel sounds were recorded every 2 hours.
flatulation
Time frame: 24 hours
.The time of the first flatulation were determined by asking the women themselves and this information was then recorded using the study form.
defecation
Time frame: 48 hours
.The time of the first defecation were determined by asking the women themselves and this information was then recorded using the study form.
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 2024.
- 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.
Rüveyda Ölmez Yalazı, PhDc principal investigator
Marmara 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 Chewing gum group, Fennel tea group and Chewing gum+Fennel tea group in people with Bowel Ileus and Cesarean Section Complications, run by Marmara 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 8 inclusion and 9 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 2024. 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?
bowel sounds (time frame: 12 hours). The study lists 3 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 2024.