Gum ChewingNCT06603025
Preoperative Chewing Gum on Anxiety and Postoperative Nausea and Vomiting, Gastrointestinal Function
A study testing chewing gum in people with Gum Chewing and Preoperative, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
The aim of this study was to investigate the effects of chewing gum before surgery on preoperative anxiety, postoperative gastrointestinal functions (time to first gas, time to first defecation, bowel sounds, abdominal distension) and nausea and vomiting in patients undergoing abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gum Chewing, Preoperative, Anxiety
- What is being tested?
- chewing gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCyprus
- Study dates
- 6 Sep 2024to Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status I-II
- body mass index (BMI) < 30 (kg/m2)
- individuals undergoing abdominal surgery
Who cannot join
- emergency surgery
Trial locations and contacts
1 site in 1 country.
Cyprus1 site
Eastern Mediterranean University
Famagusta, North Cyprus Via Mersin, 99628
About this study
Official title: Investigation of the Effect of Preoperative Gum Chewing on Anxiety, Gastrointestinal Function, Nausea and Vomiting in Patients Undergoing Abdominal Surgery: A Randomized Controlled Trial
The aim of this study was to investigate the effects of chewing gum before surgery on preoperative anxiety, postoperative gastrointestinal functions (time to first gas, time to first defecation, bowel sounds, abdominal distension) and nausea and vomiting in patients undergoing abdominal surgery.
Hypotheses of the Study: In patients undergoing abdominal surgery; H1.1: The first gas output time (hour) is shorter in patients who chew gum before surgery compared to patients who do not chew gum
Read more
H1.2: The first defecation time (hour) is shorter in patients who chew gum before surgery compared to patients who do not chew gum
H1.3: The bowel sounds are heard shorter in patients who chew gum before surgery compared to patients who do not chew gum H1.4: The abdominal distension rate is lower in patients who chew gum before surgery compared to patients who do not chew gum H1.5: The nausea and vomiting rate is lower in patients who chew gum before surgery compared to patients who do not chew gum H1.6: Preoperative anxiety levels of patients who chew gum before surgery are lower than those of patients who do not chew gum
Preoperative intervention group patients will chew sugarless gum for at least 30 minutes 30-60 minutes before surgery. The gum will be removed before going to the operating room. No intervention will be performed on control group patients, and standard care will be applied.
Read the detailed description
The aim of this study was to investigate the effects of chewing gum before surgery on preoperative anxiety, postoperative gastrointestinal functions (time to first gas, time to first defecation, bowel sounds, abdominal distension) and nausea and vomiting in patients undergoing abdominal surgery.
This study will be conducted as a single-center prospective randomized controlled trial in accordance with the principles of the Declaration of Helsinki. The study will be conducted in a private hospital in the Gazimağusa region on patients who will undergo abdominal surgery. Preoperative intervention group patients will chew sugarless gum for at least 30 minutes 30-60 minutes before surgery. The gum will be removed before going to the operating room. No intervention will be performed on control group patients, and standard care will be applied.
Sample inclusion criteria
- Patients with ASA scores I and II (ASA Physical Status Classification System)
- Patients with BMI < 30 (kg/m2)
- Patients over the age of 18 who will undergo abdominal surgery
- Patients who have the ability to read and understand the research instructions
- Patients who agree to participate in the research Sampling exclusion criteria
- Patients who do not accept chewing gum The number of samples to be included in the study was calculated by taking into account the median values of the first gas outlet time in the study of Bang et al. (2022). Accordingly, the median values of the first gas outlet time were 26.4 [15.2-39.2] hours in the control group and 20.6 [16.8-38.9] hours in the experimental group (Bang et al. 2022). Accordingly, it was planned to include a total of 70 patients, with an effect size of d = 0.70, a margin of error of α = 0.05, and a power of 80%, with a required sample size of 35 in each group. Considering that there may be missing data, it was decided to increase the sample size by 10% and include 39 patients in each group, making a total of 78 patients.
The time to first gas discharge after surgery, the time to first defecation, the duration of hospital stay, the frequency of nausea, vomiting and abdominal distension, the time and number of bowel sounds heard, and the need for antiemetic medication after surgery will be recorded in the experimental and control groups.
- Conditions
- Gum Chewing, Preoperative, Anxiety, Postoperative Nausea and Vomiting
- Being tested
- chewing gum
- Keywords
- Chewing Gum, Abdomen/surgery,, Postoperative Complications, Gastrointestinal Function, Ileus
- Medical subject headings
- Anxiety Disorders, Postoperative Nausea and Vomiting, Postoperative Complications, Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chewing gumOther
Preoperative intervention group patients will chew sugarless gum for at least 30 minutes 30-60 minutes before surgery. The gum will be removed before going to the operating room.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Preoperative intervention group patients will chew sugarless gum for at least 30 minutes 30-60 minutes before surgery. The gum will be removed before going to the operating room. Receives: Other: chewing gum |
| Control group | No intervention | standard care (no chewing gum) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the preoperative anxiety
the preoperative anxiety using APAIS immediately before entering OR. The APAIS scale consists of 6 items, and each statement is given a numerical value based on a 5-point Likert scale according to severity. These values, which vary between 1-5; 1=none, 2=mild, 3=moderate, 4=severe, 5=extremely severe. The scores on the anxiety of APAIS range from 6 (not anxious) to 30 (extremely anxious).
Measured: before entering OR
Secondary outcomes (5)
abdominal distantion
abdominal distension (frequency). abdominal distantion will be evaluated by performing an abdominal examination every 4 hours. Abdominal distension will be evaluated as present or absent after the evaluation.
Measured: 1 day after surgery. after surgery, the patient will be evaluated every 4 hours up to 48-72 hours after surgery
nausea, vomiting
nausea and vomiting(frequency). The patient will be asked whether they have nausea/vomiting. The patients nausea and vomiting status and frequency will be recorded.
Measured: 1 day after surgery. The patient will be asked every 4 hours whether they have nausea/vomiting up to 48-72 hours after surgery
Time to first flatus
The mean time to first flatus (hours). The time to first flatus will be evaluated by asking the patient after the surgery. If there is gas discharge, it will be evaluated as yes and the time of gas discharge after the surgery will be recorded.
Measured: after surgery until the first flatus up to 48-72 hours
Time to first bowel movement
Time to first bowel sounds (Hours). Patients bowel movements will be examined abdominally using a stethoscope to detect the intestinal movement every 4 hours
Measured: after surgery until the first bowel movements up to 48-72 hours
first defecation time
The mean time to first defecation time (hours). The time to first defecation time will be evaluated by asking the patient after the surgery. If there is first defecation, it will be evaluated as yes and the time of first defecation after the surgery will be recorded.
Measured: after surgery until the patients defecation time up to 48-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start6 Sep 2024
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gum ChewingStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- prospective randomized controlled trial with experimental and control groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülten Sucu Dağ, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603025
- Sponsor's protocol ID
- GSD-2
- Status last verified
- Feb 2025
- First submitted
- 28 Aug 2024
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bang YJ, Lee JH, Kim CS, Lee YY, Min JJ. Anxiolytic effects of chewing gum during preoperative fasting and patient-centered outcome in female patients undergoing elective gynecologic surgery: randomized controlled study. Sci Rep. 2022 Mar 9;12(1):4165. doi: 10.1038/s41598-022-07942-6.
PubMed 35264684
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Preoperative Gum Chewing on Anxiety, Gastrointestinal Function, Nausea and Vomiting in Patients Undergoing Abdominal Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06603025
- Acronym / sponsor ID
- GSD-2
- Conditions
- Gum Chewing, Preoperative, Anxiety, Postoperative Nausea and Vomiting
- Keywords
- Chewing Gum, Abdomen/surgery,, Postoperative Complications, Gastrointestinal Function, Ileus
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 6 Sep 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 19 Sep 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 aim of this study was to investigate the effects of chewing gum before surgery on preoperative anxiety, postoperative gastrointestinal functions (time to first gas, time to first defecation, bowel sounds, abdominal distension) and nausea and vomiting in patients undergoing abdominal surgery.
Hypotheses of the Study: In patients undergoing abdominal surgery; H1.1: The first gas output time (hour) is shorter in patients who chew gum before surgery compared to patients who do not chew gum
H1.2: The first defecation time (hour) is shorter in patients who chew gum before surgery compared to patients who do not chew gum
H1.3: The bowel sounds are heard shorter in patients who chew gum before surgery compared to patients who do not chew gum H1.4: The abdominal distension rate is lower in patients who chew gum before surgery compared to patients who do not chew gum H1.5: The nausea and vomiting rate is lower in patients who chew gum before surgery compared to patients who do not chew gum H1.6: Preoperative anxiety levels of patients who chew gum before surgery are lower than those of patients who do not chew gum
Preoperative intervention group patients will chew sugarless gum for at least 30 minutes 30-60 minutes before surgery. The gum will be removed before going to the operating room. No intervention will be performed on control group patients, and standard care will be applied.
Detailed description
The aim of this study was to investigate the effects of chewing gum before surgery on preoperative anxiety, postoperative gastrointestinal functions (time to first gas, time to first defecation, bowel sounds, abdominal distension) and nausea and vomiting in patients undergoing abdominal surgery.
This study will be conducted as a single-center prospective randomized controlled trial in accordance with the principles of the Declaration of Helsinki. The study will be conducted in a private hospital in the Gazimağusa region on patients who will undergo abdominal surgery. Preoperative intervention group patients will chew sugarless gum for at least 30 minutes 30-60 minutes before surgery. The gum will be removed before going to the operating room. No intervention will be performed on control group patients, and standard care will be applied.
Sample inclusion criteria
- Patients with ASA scores I and II (ASA Physical Status Classification System)
- Patients with BMI < 30 (kg/m2)
- Patients over the age of 18 who will undergo abdominal surgery
- Patients who have the ability to read and understand the research instructions
- Patients who agree to participate in the research Sampling exclusion criteria
- Patients who do not accept chewing gum The number of samples to be included in the study was calculated by taking into account the median values of the first gas outlet time in the study of Bang et al. (2022). Accordingly, the median values of the first gas outlet time were 26.4 [15.2-39.2] hours in the control group and 20.6 [16.8-38.9] hours in the experimental group (Bang et al. 2022). Accordingly, it was planned to include a total of 70 patients, with an effect size of d = 0.70, a margin of error of α = 0.05, and a power of 80%, with a required sample size of 35 in each group. Considering that there may be missing data, it was decided to increase the sample size by 10% and include 39 patients in each group, making a total of 78 patients.
The time to first gas discharge after surgery, the time to first defecation, the duration of hospital stay, the frequency of nausea, vomiting and abdominal distension, the time and number of bowel sounds heard, and the need for antiemetic medication after surgery will be recorded in the experimental and control groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective randomized controlled trial with experimental and control groups
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: chewing gumPreoperative intervention group patients will chew sugarless gum for at least 30 minutes 30-60 minutes before surgery. The gum will be removed before going to the operating room. |
| Control group | No intervention | –standard care (no chewing gum) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists physical status I-II
- body mass index (BMI) < 30 (kg/m2)
- individuals undergoing abdominal surgery
Key exclusion criteria (1 listed)
- emergency surgery
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 |
|---|---|---|
| chewing gumPreoperative intervention group patients will chew sugarless gum for at least 30 minutes 30-60 minutes before surgery. The gum will be removed before going to the operating room. | Other | Intervention group |
Primary outcome
the preoperative anxiety
Time frame: before entering OR
the preoperative anxiety using APAIS immediately before entering OR. The APAIS scale consists of 6 items, and each statement is given a numerical value based on a 5-point Likert scale according to severity. These values, which vary between 1-5; 1=none, 2=mild, 3=moderate, 4=severe, 5=extremely severe. The scores on the anxiety of APAIS range from 6 (not anxious) to 30 (extremely anxious).
5 secondary outcomes
abdominal distantion
Time frame: 1 day after surgery. after surgery, the patient will be evaluated every 4 hours up to 48-72 hours after surgery
nausea, vomiting
Time frame: 1 day after surgery. The patient will be asked every 4 hours whether they have nausea/vomiting up to 48-72 hours after surgery
Time to first flatus
Time frame: after surgery until the first flatus up to 48-72 hours
Time to first bowel movement
Time frame: after surgery until the first bowel movements up to 48-72 hours
first defecation time
Time frame: after surgery until the patients defecation time up to 48-72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Results publication: PubMed 35264684Bang YJ, Lee JH, Kim CS, Lee YY, Min JJ. Anxiolytic effects of chewing gum during preoperative fasting and patient-centered outcome in female patients undergoing elective gynecologic surgery: randomized controlled study. Sci Rep. 2022 Mar 9;12(1):4165. doi: 10.1038/s41598-022-07942-6.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chewing gum in people with Gum Chewing and Preoperative, run by Eastern Mediterranean University at 1 site in Cyprus.
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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 26 Feb 2025. 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 Cyprus. 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?
This study is still under way. Results are not available in the source record yet.
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?
the preoperative anxiety (time frame: before entering OR). 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 NCT06603025, which also lists 1 linked publication.
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 26 Feb 2025.