Chewing Gum During a Pap Smear
2 other identifiers
interventional
103
1 country
1
Brief Summary
This study, which was conducted to determine the effects of chewing gum on anxiety and pain during Pap smear, found that chewing gum reduced pain but had no effect on anxiety.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedFirst Submitted
Initial submission to the registry
August 3, 2025
CompletedFirst Posted
Study publicly available on registry
August 15, 2025
CompletedAugust 15, 2025
August 1, 2025
1 month
August 3, 2025
August 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in pain level during Pap smear procedure
Change from baseline in self-reported pain score, measured using the Visual Analog Scale (VAS; 0-10), during and immediately after the Pap smear procedure
Immediately after completion of the Pap smear procedure (within approximately 10 minutes)
Change in anxiety level during gynecological examination
Change from baseline in self-reported anxiety score, measured using the State-Trait Anxiety Inventory (STAI; range 20-80), during and immediately after the gynecological examination
Immediately after completion of the gynecological examination (within approximately 10 minutes)
Study Arms (2)
experimental group (chewing gum)
EXPERIMENTALParticipants in the experimental group were given gum after the pretest and asked to chew it. They were asked to chew it until they stepped off the gynecological examination table. The women chewed gum for an average of 10 minutes. The gum they were given was unflavored and sugar-free.
control group (no intervention)
NO INTERVENTIONParticipants in the control group received no intervention.
Interventions
Chewing gum is a cost-effective practice that can provide comfort to women. A Pap smear is an important test. Women experiencing pain, anxiety, or other symptoms may discourage testing. Chewing gum can reduce these sensitivities.
Eligibility Criteria
You may qualify if:
- Women who are literate, can speak and understand Turkish, are not pregnant, are not in menopause, and have experienced sexuality
You may not qualify if:
- women diagnosed with cervical cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Firat Universitylead
Study Sites (1)
Firat Universty
Elâzığ, Turkey, 23100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Block randomization was used to assign participants to the experimental and control groups to ensure equal distribution between groups. Block randomization reduced selection bias and ensured uniformity in group size. A block size of four was set at four, ensuring that two participants were assigned to the intervention group and two to the control group. Using SPSS 25.0 statistical software, all possible group combinations (e.g., DDKK, KDKD, DKDK, KKDD, etc.) were randomly generated to achieve a 1:1 assignment ratio. Group assignments within each combination were placed individually in envelopes with envelope numbers, the contents of which were hidden from view. Participants were asked to randomly select one of these envelopes in the order they arrived at the clinic before data collection. Participants were assigned to the relevant group based on the group information written inside the envelope.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Department of Obstetrics and Gynecology Nursing
Study Record Dates
First Submitted
August 3, 2025
First Posted
August 15, 2025
Study Start
July 1, 2025
Primary Completion
July 31, 2025
Study Completion
July 31, 2025
Last Updated
August 15, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share