Stress Balls in Gynecologic Exams: A Patient Comfort Trial

NCT ID: NCT06679231

Last Updated: 2025-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-10

Study Completion Date

2025-04-08

Brief Summary

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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

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Conditions

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Gynecologic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Stress 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.

Group Type EXPERIMENTAL

Stress Ball

Intervention Type BEHAVIORAL

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.

Control

After the initial measurements of the participants assigned to the control group, the student involved in the project will prepare the patient for a gynecological examination. Patients in the control group will be provided with only a relaxing environment, without a stress ball during the examination.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Stress 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Betul Uncu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ağrı Training and Research Hospital

Ağrı, Ağrı, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Nguyen L, Lamarche L, Lennox R, Ramdyal A, Patel T, Black M, Mangin D. Strategies to Mitigate Anxiety and Pain in Intrauterine Device Insertion: A Systematic Review. J Obstet Gynaecol Can. 2020 Sep;42(9):1138-1146.e2. doi: 10.1016/j.jogc.2019.09.014. Epub 2019 Dec 25.

Reference Type BACKGROUND
PMID: 31882291 (View on PubMed)

Other Identifiers

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E-95531838-050.99-116026

Identifier Type: -

Identifier Source: org_study_id

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