Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403215
Status:
COMPLETED
Last Update Posted:
2024-05-07
First Post:
2024-05-02
Brief Title:
Effect of Chewing Gum and Drinking Fennel Tea
Sponsor:
Marmara University
Organization:
Marmara University
Study Overview
Official Title:
The Effect of Chewing Gum and Drinking Fennel Tea on Intestinal Motility After Cesarean Section A Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 1850-2499 kgm2 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 patients 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 092017586 All patients signed informed consents
Data Analysis Chi-square and Fisher tests were used to compare categorical data Spearmans rank correlation coefficient was used to analyze and compare the statistical data A value of p005 was accepted for the statistical significance of the comparisons
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 patients 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 092017586 All patients signed informed consents
Data Analysis Chi-square and Fisher tests were used to compare categorical data Spearmans rank correlation coefficient was used to analyze and compare the statistical data A value of p005 was accepted for the statistical significance of the comparisons
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None