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Stress Balls in Gynecologic Exams: A Patient Comfort Trial

Improving Patient Experience in Gynecologic Examinations With a Stress Ball: A Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06679231
Enrollment
141
Registered
2024-11-07
Start date
2024-12-10
Completion date
2025-04-08
Last updated
2026-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic

Keywords

pain, women health, pap-smear, anxiety

Brief summary

Women's anxiety about gynecological examinations causes them to skip examinations during this process. Research shows that women with high levels of anxiety are more likely to feel pain. Women who can manage their anxiety can increase their satisfaction by reducing pain levels during the examination . The stress ball has the potential to improve the patient experience by reducing these anxieties. This will positively affect women's willingness to participate in gynecological examinations and follow-up processes.

Detailed description

Secondary outcomes (anxiety and patient satisfaction) were pre-specified in the ethics committee-approved study protocol and were collected as planned. These outcomes were inadvertently omitted from the initial trial registry entry and have now been added to accurately reflect the original protocol.

Interventions

BEHAVIORALStress Ball

After the initial measurements of the participants assigned to the experimental group, the students involved in the project will accompany the patient and prepare the patient for the gynecological examination. To make the patient feel more comfortable during the gynecological examination, she will be given two stress balls. The patient will be asked to count each time she squeezes the stress ball during the examination. During the gynecological procedure, the participant will be administered the first EC-3. The stress ball intervention will help to reduce the participant's anxiety level and make the examination process more tolerable. In addition, the student's support to the patient will make the examination more comfortable and contribute to the participant's psychological well-being.

Sponsors

Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* Being between the ages of 18-35, * Being literate, knowing and understanding Turkish, * Don't have a pap-smear test for the first time,

Exclusion criteria

* Presence of chronic pain in the pelvic region, * Presence of a condition in the wrists that prevents squeezing the stress ball, * Congenital malformation of the cervix, .Having a known diagnosis of a serious psychiatric illness.

Design outcomes

Primary

MeasureTime frameDescription
Pain intensity during Pap smear procedureImmediately after the Pap smear procedurePain assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).

Secondary

MeasureTime frameDescription
Change in State Anxiety LevelImmediately after the Pap smear procedureState anxiety assessed using the State-Trait Anxiety Inventory (STAI Form TX-1). Scores range from 20 to 80, with higher scores indicating greater anxiety.
Patient Satisfaction with the Gynecological ExaminationImmediately after the Pap smear procedurePatient satisfaction assessed using the Short-Form Patient Satisfaction Questionnaire (SFPSQ). Higher scores indicate greater dissatisfaction with the examination experience.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026