An interventional study of Chewing gum group and Fennel tea group in Bowel Ileus and Cesarean Section Complications, sponsored by Marmara University. Completed at 1 site in Turkey. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-07.
Sponsored by Marmara University · Not applicable, Interventional, and Prevention
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.
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.
167 studies on the registry are indexed under Ileus; 23 are open to participants now.
This study's enrollment of 120 is above the median of 90 across 138 interventional studies indexed under Ileus.
Browse Ileus studies →Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Chewing gum 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.
Other: Fennel tea 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.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.
Other: Chewing gum+Fennel tea group
Researcher sounded in bowel movement as hospital protocols.
Other: Control 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.
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).
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).
No intervention
bowel sounds
Bowel sounds were recorded every 2 hours.
Time frame: 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.
Time frame: 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.
Time frame: 48 hours
Plan to share: No
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