NCT07124182

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 15, 2025

Completed
Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

1 month

First QC Date

August 3, 2025

Last Update Submit

August 8, 2025

Conditions

Keywords

pap smearpainanxietygum

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)

EXPERIMENTAL

Participants 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.

Other: shewing gum

control group (no intervention)

NO INTERVENTION

Participants 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.

experimental group (chewing gum)

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPap smear with vaginal examination is only suitable for women
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Study Sites (1)

Firat Universty

Elâzığ, Turkey, 23100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

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
Model Details: A prospective, randomized controlled trial was conducted to determine the effects of chewing gum on anxiety and pain in women during pap smears.
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

Locations