Gynecologic NursingNCT06196138
The Effect of Chewing Gum and Hot Compresses on Gynecologic Oncologic Surgery
A study testing Gum and Hot Compress in people with Gynecologic Nursing and Pain, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
The passage discusses the recovery of gastrointestinal (GI) function after abdominal surgery and the potential impact on patient comfort. After surgery, small bowel activity typically returns to normal within a few hours, gastric activity within 24-48 hours, and colonic activity within 48-72 hours. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Nursing, Pain
- What is being tested?
- Gum and Hot Compress
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Abdurrahman Yalcin Training and Research Hospital
Ankara
About this study
Official title: The Effect of Chewing Gum and Hot Compresses on Postoperative Pain, Bowel Function, and Patient Comfort After Gynecologic Oncologic Surgery: A Randomized Controlled Trial
The passage discusses the recovery of gastrointestinal (GI) function after abdominal surgery and the potential impact on patient comfort. After surgery, small bowel activity typically returns to normal within a few hours, gastric activity within 24-48 hours, and colonic activity within 48-72 hours. However, the delayed mobility of the GI system postoperatively can lead to issues such as abdominal bloating, nausea, vomiting, and pain. These symptoms can negatively affect patient comfort, leading to increased post-operative pain, decreased mobility, reduced satisfaction, and a longer hospital stay. Therefore, interventions that expedite the normalization of bowel activity are crucial. Chewing is suggested to stimulate intestinal motility by activating the cephalovagal pathway, which influences neurogenic and hormonal factors regulating GI functions. Postoperative heat application aims to prevent hypothermia, enhance bodily functions, and potentially promote bowel motility by stimulating somatic nerves. The study explores the effects of gum chewing and hot application protocols on postoperative pain, bowel function, and patient comfort after gynecologic oncologic surgery. It aims to contribute valuable insights to the existing literature on postoperative outcomes.
Read the detailed description
After abdominal surgery, small bowel activity returns to normal within a few hours, gastric activity within 24-48 hours, and colonic activity within 48-72 hours. Due to the delayed mobility of the gastrointestinal (GI) system in the postoperative period, gas and secretions accumulated in the stomach and intestines cause abdominal bloating, nausea, vomiting, and pain, negatively impacting patient comfort. This can lead to increased post-operative pain, decreased post-operative mobility, decreased patient satisfaction and prolonged hospital stay. Therefore, procedures that shorten the time to normalization of bowel activity in the postoperative period are very important. Chewing stimulates intestinal motility in humans. The chewing mechanism is thought to work by stimulating the cephalovagal pathway. Stimulation of the cephalovagal pathway stimulates various neurogenic and hormonal factors that modulate the functions of the gastrointestinal tract. Problems related to decreased intestinal motility after minimally invasive surgery can cause postoperative side effects due to delayed recovery of GI function. The basic rationale of postoperative heat application is to prevent the development of hypothermia during and after surgery by regionally warming the patient's body, eliminating the slowing effect of hypothermia, and helping to activate bodily functions early. It has been suggested that heat application may reflexively promote bowel motility by stimulating somatic nerves via the supraspinal or spinal cord, and it has been demonstrated that stimulation of warm receptors in the skin with heat may reflexly inhibit sympathetic nerves and promote parasympathetic nerve activity in the bowel as a supraspinal and spinal reflex. There are few studies in the literature examining the effect of chewing gum and heat application on postoperative outcomes after gynecologic oncologic surgery. No study was found that compared the two applications. This study was designed to compare the effects of gum chewing and hot application protocols on postoperative pain, bowel function, and patient comfort after gynecologic oncologic surgery. It is believed that this study will make an important contribution to the literature.
- Conditions
- Gynecologic Nursing, Pain
- Being tested
- Gum, Hot Compress
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GumOther
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.
Hot CompressOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Gum | Experimental | Patients who will chew gum after surgery will constitute this group Receives: Other: Gum |
| Hot Compress | Experimental | Patients who will undergo hot compress after surgery will constitute this group Receives: Other: Hot Compress |
| Control | No intervention | Patients who will undergo routine protocol will constitute this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
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.
Measured: 8 months
General Comfort Scale
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.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start1 Jan 2024
- Primary completion1 Nov 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gynecologic NursingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Responsible party
- Principal investigator, Eda Polat, Istanbul Medeniyet University
- Investigators
- Merve Beke, MSc, Principal investigator, Dr. Abdurrahman Yalcin Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196138
- Sponsor's protocol ID
- IstanbulMU20
- Status last verified
- Mar 2024
- First submitted
- 22 Dec 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision will be made by the researchers at the end of the research.
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.
PubMed 34217437Schneider 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.
PubMed 31616986Nanthiphatthanachai 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.
PubMed 32212805Phutsisen 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.
PubMed 31779993Yin 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.
PubMed 36733360
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chewing Gum and Hot Compresses on Postoperative Pain, Bowel Function, and Patient Comfort After Gynecologic Oncologic Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06196138
- Acronym / sponsor ID
- IstanbulMU20
- Conditions
- Gynecologic Nursing, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Collaborators
- Istanbul University, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The passage discusses the recovery of gastrointestinal (GI) function after abdominal surgery and the potential impact on patient comfort. After surgery, small bowel activity typically returns to normal within a few hours, gastric activity within 24-48 hours, and colonic activity within 48-72 hours. However, the delayed mobility of the GI system postoperatively can lead to issues such as abdominal bloating, nausea, vomiting, and pain. These symptoms can negatively affect patient comfort, leading to increased post-operative pain, decreased mobility, reduced satisfaction, and a longer hospital stay. Therefore, interventions that expedite the normalization of bowel activity are crucial. Chewing is suggested to stimulate intestinal motility by activating the cephalovagal pathway, which influences neurogenic and hormonal factors regulating GI functions. Postoperative heat application aims to prevent hypothermia, enhance bodily functions, and potentially promote bowel motility by stimulating somatic nerves. The study explores the effects of gum chewing and hot application protocols on postoperative pain, bowel function, and patient comfort after gynecologic oncologic surgery. It aims to contribute valuable insights to the existing literature on postoperative outcomes.
Detailed description
After abdominal surgery, small bowel activity returns to normal within a few hours, gastric activity within 24-48 hours, and colonic activity within 48-72 hours. Due to the delayed mobility of the gastrointestinal (GI) system in the postoperative period, gas and secretions accumulated in the stomach and intestines cause abdominal bloating, nausea, vomiting, and pain, negatively impacting patient comfort. This can lead to increased post-operative pain, decreased post-operative mobility, decreased patient satisfaction and prolonged hospital stay. Therefore, procedures that shorten the time to normalization of bowel activity in the postoperative period are very important. Chewing stimulates intestinal motility in humans. The chewing mechanism is thought to work by stimulating the cephalovagal pathway. Stimulation of the cephalovagal pathway stimulates various neurogenic and hormonal factors that modulate the functions of the gastrointestinal tract. Problems related to decreased intestinal motility after minimally invasive surgery can cause postoperative side effects due to delayed recovery of GI function. The basic rationale of postoperative heat application is to prevent the development of hypothermia during and after surgery by regionally warming the patient's body, eliminating the slowing effect of hypothermia, and helping to activate bodily functions early. It has been suggested that heat application may reflexively promote bowel motility by stimulating somatic nerves via the supraspinal or spinal cord, and it has been demonstrated that stimulation of warm receptors in the skin with heat may reflexly inhibit sympathetic nerves and promote parasympathetic nerve activity in the bowel as a supraspinal and spinal reflex. There are few studies in the literature examining the effect of chewing gum and heat application on postoperative outcomes after gynecologic oncologic surgery. No study was found that compared the two applications. This study was designed to compare the effects of gum chewing and hot application protocols on postoperative pain, bowel function, and patient comfort after gynecologic oncologic surgery. It is believed that this study will make an important contribution to the literature.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gum | Experimental | Other: GumPatients who will chew gum after surgery will constitute this group |
| Hot Compress | Experimental | Other: Hot CompressPatients who will undergo hot compress after surgery will constitute this group |
| Control | No intervention | –Patients who will undergo routine protocol will constitute this group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GumIn 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. | Other | Gum |
| Hot CompressStarting 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. | Other | Hot Compress |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 34217437Akladios 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.
- Background: PubMed 31616986Schneider 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.
- Background: PubMed 32212805Nanthiphatthanachai 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.
- Background: PubMed 31779993Phutsisen 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.
- Results publication: PubMed 36733360Yin 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.
- Individual participant dataSharing planned: Undecided. A decision will be made by the researchers at the end of the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merve Beke, MSc principal investigator
Dr. Abdurrahman Yalcin Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gum and Hot Compress in people with Gynecologic Nursing and Pain, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06196138, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.