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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Turkey (Türkiye)1 site
  • Marmara University

    Istanbul, 34854

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06403215
Study groupRoleWhat they receive
Chewing gum groupExperimentalWomen 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 groupExperimentalWomen 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 groupExperimentalWomen 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 groupExperimentalResearcher 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.

  1. bowel sounds

    Bowel sounds were recorded every 2 hours.

    Measured: 12 hours

  2. 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

  3. 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.

  1. First posted7 May 2024
  2. Study start11 Sep 2017
  3. Primary completion30 Apr 2018
  4. Study completion30 Jun 2019

Resources

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)
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

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.

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