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Completed

NCT Number: NCT06679231

Stress Balls in Gynecologic Exams: A Patient Comfort Trial

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.

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Key information

Conditions

Gynecologic Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ağrı Training and Research Hospital

Ağrı, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

stress ball

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.

Primary outcomes

  1. Pain intensity during Pap smear procedure

    Time frame: Immediately after the Pap smear procedure

    Pain assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).

Secondary outcomes

  1. Change in State Anxiety Level

    Time frame: Immediately after the Pap smear procedure

    State anxiety assessed using the State-Trait Anxiety Inventory (STAI Form TX-1). Scores range from 20 to 80, with higher scores indicating greater anxiety.

  2. Patient Satisfaction with the Gynecological Examination

    Time frame: Immediately after the Pap smear procedure

    Patient satisfaction assessed using the Short-Form Patient Satisfaction Questionnaire (SFPSQ). Higher scores indicate greater dissatisfaction with the examination experience.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 7, 2024
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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