The Effect of Chewing Gum After Cesarean Section on Gastrointestinal System Functions, Pain and Sleep Quality

NCT05945095 | Unknown

• 1 other identifier: Gum after cesarean section
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be conducted on mothers who had planned cesarean section.After the birth, the information about the surgery in the personal information form will be completed. Then, mothers in the control group will be given standard postpartum care. The mothers in the experimental group, on the other hand, will chew sugar-free gum for at least 15 minutes, starting from the second hour after the surgery. The gum chewing process will be repeated every two hours. Mothers will be mobilized at the 8th sat after the birthday. Pain levels of mothers in both groups will be evaluated every two hours after delivery. In addition, the amount of analgesic use will be compared and comments will be made on the level of pain. The sleep quality of the postpartum women will be questioned the day after the cesarean section.

Conditions

Mothers; Cesarean Section Complications

Keywords

General anesthesia,; Sleep Quality; Chewing Gum, Pain,; Cesarean section,

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS)

  VAS is used to measure perceived pain. VAS is a 10cm line with anchor statements on lower end (no pain) and on upper end (extreme pain). The mother is asked to mark their current pain level on the line

  "change" is being assessed. up to 10-12 hours after cesarean section

Secondary Outcomes (1)

• Richard-Campbell Sleep Scale (RCUI)

  in the morning the day after the cesarean section

Study Arms (2)

Experimental group

EXPERIMENTAL

Gum chewing group

Other: Gum chewing group

Control group

NO INTERVENTION

Routine care

Interventions

Gum chewing group OTHER

The mothers in the experimental group, on the other hand, will chew sugar-free gum for at least 15 minutes, starting from the second hour after the surgery.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be eighteen years of age or older,
• Having a planned cesarean section,
• To receive general anesthesia in the surgery,
• No history of chronic constipation and diarrhea,
• At least primary school graduate
• Communication is not a problem.

Sponsors & Collaborators

• Artvin Coruh University: lead

Study Sites (1)

Artvin State Hospital

Artvin, 08000, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Pereira Gomes Morais E, Riera R, Porfirio GJ, Macedo CR, Sarmento Vasconcelos V, de Souza Pedrosa A, Torloni MR. Chewing gum for enhancing early recovery of bowel function after caesarean section. Cochrane Database Syst Rev. 2016 Oct 17;10(10):CD011562. doi: 10.1002/14651858.CD011562.pub2.

  PMID: 27747876 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Pain

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dilek KALOĞLU BİNİCİ, PhD

  Artvin Coruh University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilek KALOĞLU BİNİCİ, PhD

CONTACT

5058110022; dkaloglu@artvin.edu.tr

Enes BULUT

CONTACT

5464213863; bulutts61@artvin.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (PhD Research Nurse)

Model Details: The sample size in similar studies was examined and it was determined that at least 30 mothers should be included in the experimental and control groups. Assignment of pregnant women to the experimental and control groups will be made using a simple random numbers table.

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: July 14, 2023
• Study Start: March 27, 2023
• Primary Completion: December 27, 2023
• Study Completion: May 20, 2024
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)