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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06359223
Other study ID # 2400602
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 20, 2024
Est. completion date December 30, 2024

Study information

Verified date April 2024
Source TC Erciyes University
Contact HÜMEYRA YÜKSEL, phd student
Phone +90 539 854 27 09
Email humeyragecici@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Purpose: It will be performed to minimize the problems that the mother and the newborn may experience in the postpartum period by eliminating the negative symptoms related to postpartum pain and delayed intestinal motility. Design: It will be conducted as a randomized controlled experimental study. Method: It will consist of women who had cesarean section surgery at Necmettin Erbakan University Faculty of Medicine Hospital between April and July 2024. The sample of the research; The sample will consist of women who meet the selection criteria and voluntarily agree to participate in the research. Considering the possible 10% data loss in randomized controlled studies, a total of 50 women, 25 in each group, were planned to be sampled. Data will be collected using a personal information form and visual pain scale (VAS). . Immediately before coffee application (6-12-18 hours after surgery), women's pain intensity and bowel motility will be evaluated. Women will then be asked to consume 100 ml of unsweetened caffeinated coffee at 6, 12 and 18 hours after surgery. 6,12,18. Half an hour after coffee consumption, women will be evaluated for pain using VAS. In the control group, no procedure will be applied and pain assessment will be made with VAS at the same hours. Conclusion: It is aimed to reduce the pain and increase intestinal motility of patients who consume coffee after cesarean section. Key Words: Caesarean Section, Coffee, Pain, Motility


Description:

Cesarean section is one of the most common surgical operations in obstetrics and gynecology. While the caesarean section rate is 25-40% in developed countries such as the United States, Ireland, England and China, this rate is 48% in Turkey. For this reason, post-cesarean pain and delayed bowel motility are among the common problems due to the surgical intervention. Post-cesarean pain can delay return to normal daily activities and negatively affect the mother's psychological health, breastfeeding, and mother-infant bonding. In addition to pain, delayed bowel motility due to changes in the autonomic nervous system is among the most common problems experienced after cesarean section. Appropriate health care provided by medical personnel during the postpartum period can enable the woman to be discharged early. Therefore, non-invasive, low-cost and uncomplicated methods should be preferred to reduce pain in the postoperative period and ensure the first spontaneous passing of gas and early defecation. In the literature review, although there is no study determining the effect of drinking coffee on pain in the postoperative period, there are studies stating that coffee can contribute to early GI motility in the postoperative period after abdominal surgery and shorten the time for passing gas, defecation and discharge. Therefore, this research will be conducted as a randomized controlled experimental study with the aim of minimizing the problems that the mother and the newborn may experience in the postpartum period by eliminating the negative symptoms related to postpartum pain and delayed intestinal motility.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date December 30, 2024
Est. primary completion date July 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Giving birth by cesarean section under spinal anesthesia, - Postoperative pain intensity of 4 or more, - Within the first 48 hours after surgery - 4 hours have passed since the first analgesia was administered to women who came to the clinic after cesarean section. Exclusion Criteria: - Complicated birth - Development of any complications after surgery

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
coffee consumption
After cesarean section, patients will be allowed to drink coffee.
Other:
control group
Patients will undergo a routine surgical procedure.

Locations

Country Name City State
Turkey KTO Karatay Universty Konya Karatay

Sponsors (1)

Lead Sponsor Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

Abadi F, Shahabinejad M, Abadi F, Kazemi M. Effect of Acupressure on Symptoms of Postoperative Ileus After Cesarean Section. J Acupunct Meridian Stud. 2017 Apr;10(2):114-119. doi: 10.1016/j.jams.2016.11.008. Epub 2016 Dec 27. — View Citation

Curran EA, Khashan AS, Dalman C, Kenny LC, Cryan JF, Dinan TG, Kearney PM. Obstetric mode of delivery and attention-deficit/hyperactivity disorder: a sibling-matched study. Int J Epidemiol. 2016 Apr;45(2):532-42. doi: 10.1093/ije/dyw001. Epub 2016 Apr 10. — View Citation

Goymen, A., Simsek, Y., Ozkaplan, S. E., Ozdurak, H. I., Akpak, Y. K., Semiz, A., & Oral, S. (2017). Effect of gum chewing and coffee consumption on intestinal motility in caesarean sections.

Khadem N, Khadivzadeh T. The intelligence quotient of school aged children delivered by cesarean section and vaginal delivery. Iran J Nurs Midwifery Res. 2010 Summer;15(3):135-40. — View Citation

Souza JP, Betran AP, Dumont A, de Mucio B, Gibbs Pickens CM, Deneux-Tharaux C, Ortiz-Panozo E, Sullivan E, Ota E, Togoobaatar G, Carroli G, Knight H, Zhang J, Cecatti JG, Vogel JP, Jayaratne K, Leal MC, Gissler M, Morisaki N, Lack N, Oladapo OT, Tuncalp O — View Citation

Tian YT. 2017. China is not"The World's First Cesarean Section Rate".Beijing: Guangming Daily.

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Zamanabadi MN, Alizadeh R, Gholami F, Seyed Mehdi SA, Aryafar M. Effect of caffeine on postoperative bowel movement and defecation after cesarean section. Ann Med Surg (Lond). 2021 Aug 6;68:102674. doi: 10.1016/j.amsu.2021.102674. eCollection 2021 Aug. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative Pain The visual analog scale (VAS ) is a scale with different names at both ends on a 10 cm long vertical or horizon line. In this study, evaluation was made as "0 = no pain" and "10 = the most severe pain". 24 hour
Primary intestinal motility 6-12-18. The patient's bowel sounds will be listened to during the hours 24 hour
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