GynecologicNCT06679231
Stress Balls in Gynecologic Exams: A Patient Comfort Trial
A study testing Stress Ball in people with Gynecologic, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic
- What is being tested?
- Stress Ball
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2024to 8 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being between the ages of 18-35,
- Being literate, knowing and understanding Turkish,
- Don't have a pap-smear test for the first time,
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ağrı Training and Research Hospital
Ağrı, Ağrı
About this study
Official title: Improving Patient Experience in Gynecologic Examinations With a Stress Ball: A Randomized Controlled 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.
Read the 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.
- Conditions
- Gynecologic
- Being tested
- Stress Ball
- Keywords
- pain, women health, pap-smear, anxiety
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress BallBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Stress Ball | Experimental | 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. Receives: Behavioral: Stress Ball |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity during Pap smear procedure
Pain assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: Immediately after the Pap smear procedure
Secondary outcomes (2)
Change in State Anxiety Level
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.
Measured: Immediately after the Pap smear procedure
Patient Satisfaction with the Gynecological Examination
Patient satisfaction assessed using the Short-Form Patient Satisfaction Questionnaire (SFPSQ). Higher scores indicate greater dissatisfaction with the examination experience.
Measured: Immediately after the Pap smear procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start10 Dec 2024
- Primary completion7 Apr 2025
- Study completion8 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GynecologicStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betul Uncu, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679231
- Sponsor's protocol ID
- E-95531838-050.99-116026
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31882291
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Patient Experience in Gynecologic Examinations With a Stress Ball: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06679231
- Acronym / sponsor ID
- E-95531838-050.99-116026
- Conditions
- Gynecologic
- Keywords
- pain, women health, pap-smear, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 8 Apr 2025 (actual)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress Ball | Experimental | Behavioral: Stress BallAfter 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being between the ages of 18-35,
- Being literate, knowing and understanding Turkish,
- Don't have a pap-smear test for the first time,
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress BallAfter 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. | Behavioural | Stress Ball |
Primary outcome
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).
2 secondary outcomes
Change in State Anxiety Level
Time frame: Immediately after the Pap smear procedure
Patient Satisfaction with the Gynecological Examination
Time frame: Immediately after the Pap smear procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Background: PubMed 31882291Nguyen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Ball in people with Gynecologic, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity during Pap smear procedure (time frame: Immediately after the Pap smear procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06679231, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.