The Effect of Chewing Gum and Hot Compresses on Gynecologic Oncologic Surgery
The Effect of Chewing Gum and Hot Compresses on Postoperative Pain, Bowel Function, and Patient Comfort After Gynecologic Oncologic Surgery: A Randomized Controlled Trial
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Merve Tuncer, PhD
- Phone Number: +905375048017
- Email: mervecaglar90@hotmail.com
Study Contact Backup
- Name: Eda Polat, PhD
- Phone Number: +905415660731
- Email: edda_akyol@hotmail.com
Study Locations
-
-
-
Ankara, Turkey (Türkiye)
- Dr. Abdurrahman Yalcin Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years of age or older
- To undergo elective minimally invasive gynecologic surgery
- No cognitive, affective and mental problems that would prevent gum chewing and hot application
- Does not have any chronic disease
- No previous abdominal surgery
- Turkish speaking and
- Women who volunteer to participate in the study will be included.
Exclusion Criteria:
- Who wants to leave the work for any reason
- History of ileostomy and colostomy
- He was taken to intensive care after the surgery and
- Women with postoperative complications (bleeding, infection, etc.) will be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Gum
Patients who will chew gum after surgery will constitute this group
|
In the postoperative period, starting from the 4th hour, chewing gum is done 3 times a day, morning, noon and evening, for 30 minutes each, until the patient passes the first flatus.
|
|
Experimental: Hot Compress
Patients who will undergo hot compress after surgery will constitute this group
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Starting from the 1st postoperative day, patients will receive hot application (to the lumbar region) for 10 minutes in the morning and evening.
The hot application is applied by wrapping 2 towels in a water bag containing 55 ± 2 °C hot water.
The water bag is applied to the lumbar region for 10 minutes with the patient in the supine position.
The application is continued until the patient passes the first flatus.
|
|
No Intervention: Control
Patients who will undergo routine protocol will constitute this group
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: 8 months
|
This scale, which can be used horizontally or vertically, is shaped like a 10 cm line.
The scale begins with "No pain" and ends with "My pain is very severe.
The person is asked to select a number between 0 and 10 that corresponds to the pain they feel on this scale.
|
8 months
|
|
General Comfort Scale
Time Frame: 8 months
|
The highest total score that can be obtained from the scale is 192 and the lowest total score is 48.
Obtained The total score depends on the number of scale items.
|
8 months
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Merve Beke, MSc, Dr. Abdurrahman Yalcin Training and Research Hospital
Publications and helpful links
General Publications
- Akladios C, Darai E, Golfier F, Lecuru F, Collinet P, Uzan C, Lavoue V, Guyon F, Ferron G, Querleu D. [National certification for gynecological cancer surgery]. Bull Cancer. 2021 Sep;108(9):806-812. doi: 10.1016/j.bulcan.2021.03.019. Epub 2021 Jun 30. French.
- Schneider S, Armbrust R, Spies C, du Bois A, Sehouli J. Prehabilitation programs and ERAS protocols in gynecological oncology: a comprehensive review. Arch Gynecol Obstet. 2020 Feb;301(2):315-326. doi: 10.1007/s00404-019-05321-7. Epub 2019 Oct 15.
- Nanthiphatthanachai A, Insin P. Effect of Chewing Gum on Gastrointestinal Function Recovery After Surgery of Gynecological Cancer Patients at Rajavithi Hospital: A Randomized Controlled Trial. Asian Pac J Cancer Prev. 2020 Mar 1;21(3):761-770. doi: 10.31557/APJCP.2020.21.3.761.
- Phutsisen J, Kietpeerakool C, Jampathong N, Chumworathayi B, Temtanakitpaisan A, Aue-Aungkul A, Boontasaeng P. Effects of Cassia alata Linn on bowel function recovery following surgery for gynecological cancer: A randomized controlled trial. Complement Ther Med. 2019 Dec;47:102222. doi: 10.1016/j.ctim.2019.102222. Epub 2019 Oct 21.
- Yin YN, Xie H, Ren JH, Jiang NJ, Dai L. The impact of gum-chewing on postoperative ileus following gynecological cancer surgery: A systematic review and meta-analysis of randomized controlled trials. Front Oncol. 2023 Jan 17;12:1059924. doi: 10.3389/fonc.2022.1059924. eCollection 2022.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Food
- Diet, Food, and Nutrition
- Physiological Phenomena
- Food and Beverages
- Carbohydrates
- Polymers
- Macromolecular Substances
- Polysaccharides
- Biological Products
- Complex Mixtures
- Biopolymers
- Plant Gums
- Plant Exudates
- Candy
- Chewing Gum
Other Study ID Numbers
Other Study ID Numbers
- IstanbulMU20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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