Pain ManagementGum-PainNCT07326254
Effect of Chewing Different Flavor Gum on Procedural Pain and Fear
A study testing Sugared Gum Chewing and Sugar-Free Gum Chewing in people with Pain Management, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
Trial summary
Needle-related pain and anxiety present persistent challenges in pediatric clinical procedures. This study aims to investigate the effects of chewing sugared and sugar-free gum on pain, anxiety, and fear in children undergoing venipuncture. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Management
- What is being tested?
- Sugared Gum Chewing and Sugar-Free Gum Chewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2024to 30 Jan 2025
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between 7-12 years of age
- Children requiring venous blood sampling
- Children able to chew gum safely
- Children who provide assent, with parental, legal guardian consent
Who cannot join
- Children with fever
- Children experiencing acute pain at the time of assessment
- Children who used analgesic medication within the previous four hours
- Children with medical conditions contraindicating gum chewing (e.g., jaw disorders)
- Children with allergy to gum ingredients
- Children with communication difficulties related to neurodevelopmental, hearing, visual impairments
- Children currently taking analgesic, sedative medications before the procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mus State Hospital, Pediatric Blood Collection Unit
Muş, Province, 49000
About this study
Official title: Determining the Effectiveness of Chewing Gums With Different Flavors in Reducing Procedural Pain and Fear in Children Aged 7 to 12
Needle-related pain and anxiety present persistent challenges in pediatric clinical procedures. This study aims to investigate the effects of chewing sugared and sugar-free gum on pain, anxiety, and fear in children undergoing venipuncture. A randomized controlled design will be used with 144 children aged 7-12 years to be recruited between November 2024 and January 2025. Participants will be randomly assigned to control, sugared gum, or sugar-free gum groups. Pain and fear will be assessed using the Visual Analog Scale (VAS), Pen Pain Scale (PPS), and Children's Fear Scale (CFS). Crying duration will be recorded as a behavioral indicator. Data will be analyzed using Kruskal-Wallis, chi-square, and Spearman correlation tests with a significance level of p < .05. The study is intended to evaluate whether chewing gum can serve as a simple, low-cost, and non-invasive method to improve comfort and cooperation during pediatric venipuncture procedures.
Read the detailed description
Needle-related procedures such as venipuncture are among the most common sources of pain, anxiety, and fear in pediatric clinical care. Negative experiences during these procedures may reduce cooperation, increase procedural difficulty, and contribute to long-term avoidance of healthcare settings. Identifying simple, low-cost, and non-pharmacological strategies to improve children's comfort during venipuncture is therefore an important clinical priority.
Chewing gum has been proposed as a potential method for modulating pain and anxiety through mechanisms such as distraction, rhythmic oral motor activity, and sensory engagement. Different gum types, including sugared and sugar-free varieties, may influence children's sensory experience differently. However, evidence regarding the use of chewing gum during pediatric procedures remains limited.
This randomized controlled study is designed to examine the effects of chewing sugared and sugar-free gum on pain, anxiety, and fear in children undergoing venipuncture. A total of 144 children aged 7-12 years will be recruited from outpatient clinical units between November 2024 and January 2025. Participants will be randomly assigned to one of three groups: a control group (no gum), a sugared gum group, or a sugar-free gum group. Children in the intervention groups will chew their assigned gum prior to and during venipuncture.
Pain will be measured using the Visual Analog Scale (VAS) and the Pen Pain Scale (PPS). Fear will be assessed using the Children's Fear Scale (CFS). Crying duration will be recorded as a behavioral indicator of distress. Demographic and clinical variables will also be collected to control for potential confounders.
Data will be analyzed using appropriate non-parametric and categorical statistical tests, including the Kruskal-Wallis test, chi-square test, and Spearman correlation analysis, with a predefined significance level of p < .05. The findings of this study are expected to contribute to the growing body of literature on non-pharmacological interventions for pediatric procedural support and may provide evidence for the integration of chewing gum as a practical technique to improve children's comfort and cooperation during venipuncture.
- Conditions
- Pain Management
- Being tested
- Sugared Gum Chewing, Sugar-Free Gum Chewing, Control
- Keywords
- pain management, chewing gum, pediatric nursing, venipuncture, anxiety
- Medical subject headings
- Agnosia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugared Gum ChewingBehavioural
Chewing sugared gum, which began one minute before the procedure, continued until the end of the blood collection. Sugared gum provided a sweet taste stimulus, while sugarless gum served as a non-sweet comparator. Children were continuously monitored to ensure safety and prevent aspiration, and children aged 7-12 were included in the study. No adverse events were reported during the study.
Sugar-Free Gum ChewingBehavioural
Participants began chewing sugarless gum one minute before the procedure began, until the blood sample was collected. The purpose of the chewing activity was to reduce pain and fear during the procedure. No other behavioral or pharmacological interventions were administered.
ControlOther
No active gum chewing intervention was performed during blood collection
| Study group | Role | What they receive |
|---|---|---|
| Sugared Gum | Experimental | Participants start chewing sugared gum one minute before the procedure and continue chewing until the procedure is over. Receives: Behavioral: Sugared Gum Chewing |
| Sugar-Free Gum | Experimental | Participants start chewing sugared gum one minute before the procedure and continue chewing until the procedure is over. Receives: Behavioral: Sugar-Free Gum Chewing |
| Control | Placebo comparator | This group did not receive any gum chewing intervention during the blood collection procedure. Standard procedures were followed. The parent was present with the child during the procedure. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Pain - Visual Analog Scale (VAS)
Pain will be assessed using the Visual Analog Scale (VAS) to measure the severity of procedural pain during venipuncture in children assigned to control, sugared gum, or sugar-free gum groups. Units on a Scale. Minimum-Maximum Value: (0-10). Higher scores indicate worse pain
Measured: Immediately following the blood collection procedure (within a few minutes)
Procedural Pain - Pen Pain Scale (PPS)
Pain will be assessed using the Pen Pain Scale (PPS) to measure the severity of procedural pain during venipuncture in children assigned to control, sugared gum, or sugar-free gum groups. Units on a Scale. Minimum-Maximum Value: (0-5): Higher scores indicate worse pain.
Measured: Immediately following the blood collection procedure (within a few minutes)
Procedural Fear - Children's Fear Scale (CFS)
Fear will be assessed using the Children's Fear Scale (CFS) to measure the level of fear experienced by children during venipuncture in control, sugared gum, or sugar-free gum groups. Units on a Scale. Minimum-Maximum Value: (0-4). Higher scores indicate greater fear
Measured: Immediately following the blood collection procedure (within a few minutes)
Secondary outcomes (2)
Duration of Crying During Venipuncture
Crying duration will be recorded as a behavioral indicator of distress in children during venipuncture in the control, sugared gum, and sugar-free gum groups.
Measured: From needle insertion until completion of venipuncture, with crying duration recorded in seconds, assessed for up to 5 minutes.
Parent Satisfaction With Child's Blood Collection Experience
Parent satisfaction will be assessed as a Yes/No response to indicate whether the parent was satisfied with their child's experience during the blood collection procedure. Unit of Measure: Yes/No
Measured: Immediately after completion of venipuncture (within 5 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start20 Nov 2024
- Primary completion15 Jan 2025
- Study completion30 Jan 2025
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 Pain ManagementStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Beyaz, Muş Alparslan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326254
- Sponsor's protocol ID
- MusAl
- Acronym
- Gum-Pain
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be shared in de-identified form upon reasonable request to the Principal Investigator. Data will be available after publication of the main results and will be provided only for research purposes with appropriate ethical approval.
Publications
Sampallo Pedroza RM, Cardona Lopez LF, Ramirez Gomez KE. Description of oral-motor development from birth to six years of age. Rev Fac Med. 2015;62(4):593-604. Davas S, Kürtüncü M. The effect of three different methods during blood collection on pain level and parental satisfaction in children. Arch Health Sci Res. 2021;8(1):60-68. Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983;17(1):45-56. Beyaz E, Tüfekçi FG. Developing a new one-dimensional scale to measure pain in children: Pencil pain scale. J Pediatr Infants. 2021;4(1):1-10. McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: Preliminary investigation of the Children's Fear Scale. Health Psychol. 2011;30(6):780-788. Gülsoy H, Toru F, Öntürk Akyüz H, Üner FÖ. The impact of kaleidoscope and distraction cards on pain level during blood drawing in children. Med Res Rep. 2024;7(3):120-132.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effectiveness of Chewing Gums With Different Flavors in Reducing Procedural Pain and Fear in Children Aged 7 to 12
- ClinicalTrials.gov ID
- NCT07326254
- Acronym / sponsor ID
- Gum-Pain / MusAl
- Conditions
- Pain Management
- Keywords
- pain management, chewing gum, pediatric nursing, venipuncture, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 8 Jan 2026 (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.
Needle-related pain and anxiety present persistent challenges in pediatric clinical procedures. This study aims to investigate the effects of chewing sugared and sugar-free gum on pain, anxiety, and fear in children undergoing venipuncture. A randomized controlled design will be used with 144 children aged 7-12 years to be recruited between November 2024 and January 2025. Participants will be randomly assigned to control, sugared gum, or sugar-free gum groups. Pain and fear will be assessed using the Visual Analog Scale (VAS), Pen Pain Scale (PPS), and Children's Fear Scale (CFS). Crying duration will be recorded as a behavioral indicator. Data will be analyzed using Kruskal-Wallis, chi-square, and Spearman correlation tests with a significance level of p < .05. The study is intended to evaluate whether chewing gum can serve as a simple, low-cost, and non-invasive method to improve comfort and cooperation during pediatric venipuncture procedures.
Detailed description
Needle-related procedures such as venipuncture are among the most common sources of pain, anxiety, and fear in pediatric clinical care. Negative experiences during these procedures may reduce cooperation, increase procedural difficulty, and contribute to long-term avoidance of healthcare settings. Identifying simple, low-cost, and non-pharmacological strategies to improve children's comfort during venipuncture is therefore an important clinical priority.
Chewing gum has been proposed as a potential method for modulating pain and anxiety through mechanisms such as distraction, rhythmic oral motor activity, and sensory engagement. Different gum types, including sugared and sugar-free varieties, may influence children's sensory experience differently. However, evidence regarding the use of chewing gum during pediatric procedures remains limited.
This randomized controlled study is designed to examine the effects of chewing sugared and sugar-free gum on pain, anxiety, and fear in children undergoing venipuncture. A total of 144 children aged 7-12 years will be recruited from outpatient clinical units between November 2024 and January 2025. Participants will be randomly assigned to one of three groups: a control group (no gum), a sugared gum group, or a sugar-free gum group. Children in the intervention groups will chew their assigned gum prior to and during venipuncture.
Pain will be measured using the Visual Analog Scale (VAS) and the Pen Pain Scale (PPS). Fear will be assessed using the Children's Fear Scale (CFS). Crying duration will be recorded as a behavioral indicator of distress. Demographic and clinical variables will also be collected to control for potential confounders.
Data will be analyzed using appropriate non-parametric and categorical statistical tests, including the Kruskal-Wallis test, chi-square test, and Spearman correlation analysis, with a predefined significance level of p < .05. The findings of this study are expected to contribute to the growing body of literature on non-pharmacological interventions for pediatric procedural support and may provide evidence for the integration of chewing gum as a practical technique to improve children's comfort and cooperation during venipuncture.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sugared Gum | Experimental | Behavioral: Sugared Gum ChewingParticipants start chewing sugared gum one minute before the procedure and continue chewing until the procedure is over. |
| Sugar-Free Gum | Experimental | Behavioral: Sugar-Free Gum ChewingParticipants start chewing sugared gum one minute before the procedure and continue chewing until the procedure is over. |
| Control | Placebo comparator | Other: ControlThis group did not receive any gum chewing intervention during the blood collection procedure. Standard procedures were followed. The parent was present with the child during the procedure. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children between 7-12 years of age
- Children requiring venous blood sampling
- Children able to chew gum safely
- Children who provide assent, with parental, legal guardian consent
Key exclusion criteria (7 listed)
- Children with fever
- Children experiencing acute pain at the time of assessment
- Children who used analgesic medication within the previous four hours
- Children with medical conditions contraindicating gum chewing (e.g., jaw disorders)
- Children with allergy to gum ingredients
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 |
|---|---|---|
| Sugared Gum ChewingChewing sugared gum, which began one minute before the procedure, continued until the end of the blood collection. Sugared gum provided a sweet taste stimulus, while sugarless gum served as a non-sweet comparator. Children were continuously monitored to ensure safety and prevent aspiration, and children aged 7-12 were included in the study. No adverse events were reported during the study. | Behavioural | Sugared Gum |
| Sugar-Free Gum ChewingParticipants began chewing sugarless gum one minute before the procedure began, until the blood sample was collected. The purpose of the chewing activity was to reduce pain and fear during the procedure. No other behavioral or pharmacological interventions were administered. | Behavioural | Sugar-Free Gum |
| ControlNo active gum chewing intervention was performed during blood collection | Other | Control |
Primary outcome
Procedural Pain - Visual Analog Scale (VAS)
Time frame: Immediately following the blood collection procedure (within a few minutes)
Pain will be assessed using the Visual Analog Scale (VAS) to measure the severity of procedural pain during venipuncture in children assigned to control, sugared gum, or sugar-free gum groups. Units on a Scale. Minimum-Maximum Value: (0-10). Higher scores indicate worse pain
Procedural Pain - Pen Pain Scale (PPS)
Time frame: Immediately following the blood collection procedure (within a few minutes)
Pain will be assessed using the Pen Pain Scale (PPS) to measure the severity of procedural pain during venipuncture in children assigned to control, sugared gum, or sugar-free gum groups. Units on a Scale. Minimum-Maximum Value: (0-5): Higher scores indicate worse pain.
Procedural Fear - Children's Fear Scale (CFS)
Time frame: Immediately following the blood collection procedure (within a few minutes)
Fear will be assessed using the Children's Fear Scale (CFS) to measure the level of fear experienced by children during venipuncture in control, sugared gum, or sugar-free gum groups. Units on a Scale. Minimum-Maximum Value: (0-4). Higher scores indicate greater fear
2 secondary outcomes
Duration of Crying During Venipuncture
Time frame: From needle insertion until completion of venipuncture, with crying duration recorded in seconds, assessed for up to 5 minutes.
Parent Satisfaction With Child's Blood Collection Experience
Time frame: Immediately after completion of venipuncture (within 5 minutes).
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 8 Jan 2026.
- Results publicationSampallo Pedroza RM, Cardona Lopez LF, Ramirez Gomez KE. Description of oral-motor development from birth to six years of age. Rev Fac Med. 2015;62(4):593-604. Davas S, Kürtüncü M. The effect of three different methods during blood collection on pain level and parental satisfaction in children. Arch Health Sci Res. 2021;8(1):60-68. Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983;17(1):45-56. Beyaz E, Tüfekçi FG. Developing a new one-dimensional scale to measure pain in children: Pencil pain scale. J Pediatr Infants. 2021;4(1):1-10. McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: Preliminary investigation of the Children's Fear Scale. Health Psychol. 2011;30(6):780-788. Gülsoy H, Toru F, Öntürk Akyüz H, Üner FÖ. The impact of kaleidoscope and distraction cards on pain level during blood drawing in children. Med Res Rep. 2024;7(3):120-132.
- Article on oral-motor developmentLink provided by the sponsor.
- Validation of VAS scaleLink provided by the sponsor.
- Distraction methods during pediatric blood drawLink provided by the sponsor.
- Distraction methods during pediatric blood drawLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be shared in de-identified form upon reasonable request to the Principal Investigator. Data will be available after publication of the main results and will be provided only for research purposes with appropriate ethical approval.
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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 Sugared Gum Chewing and Sugar-Free Gum Chewing in people with Pain Management, run by Muş Alparslan 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 4 inclusion and 7 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 8 Jan 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. Some participants in this study may receive a placebo. 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?
Procedural Pain - Visual Analog Scale (VAS) (time frame: Immediately following the blood collection procedure (within a few minutes)). The study lists 3 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 NCT07326254, 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 8 Jan 2026.