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Pain ManagementNCT06682052

Stress Ball Application on Anxiety and Pain During Pap Smear Test

A study testing anti-stress ball in people with Pain Management, run by Hitit University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

A negative pelvic examination experience may deter women from returning for follow-up tests, thus reducing the intended benefit of gynecological screening. For all these reasons, women's experiences with pelvic examinations and related conditions should be taken into account by healthcare services. Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pain Management
What is being tested?
anti-stress ball
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
No sites listed yet
Study dates
20 Dec 2024to 15 Mar 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Women aged 18 and over,
  • At least primary school graduates,
  • Not pregnant,
  • Married,
  • No physical obstacles to using the anti-stress ball,
  • Those who agree to participate in the study.

Who cannot join

  • Acute pelvic pain,
  • Any injury or lesion to the perineum that may cause pain during the examination,
  • Analgesic or anxiolytic use within 24 hours before the examination,
  • Vaginismus,
  • History of sexual abuse,
  • History of a traumatic pelvic examination.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Fatma Yıldırım Dr contact

05466742445

fatmadmryldrm@gmail.com

About this study

Official title: Stress Ball Application on Pap Smear Test

A negative pelvic examination experience may deter women from returning for follow-up tests, thus reducing the intended benefit of gynecological screening. For all these reasons, women's experiences with pelvic examinations and related conditions should be taken into account by healthcare services. Although the pelvic examination is relatively brief, cognitive-behavioral interventions that focus or distract the patient's attention have been shown to be effective in reducing pain and anxiety during brief medical interventions. Reducing pain and anxiety during medical procedures is an important factor in patient satisfaction. Although there are many methods to reduce stress, it is thought that the inexpensive and easily accessible anti-stress ball can be used as a distraction method. A study has determined that a stress ball reduces anxiety and pain during angiography. No studies were found in the literature examining the effects of an anti-stress ball on anxiety and pain during a pelvic examination.

Read the detailed description

Pelvic examination is a common approach to evaluate a woman's external and internal genitalia and pelvic organs. Pelvic examination is usually performed during gynecological health checks; as part of the diagnosis, treatment, and follow-up of gynecological problems (e.g., sexually transmitted infections, genital cancer, pap smear test); and during perinatal care. Although women usually have a pelvic examination at least once in their lifetime, they avoid having further pelvic examinations due to fear that their privacy may be compromised. Women often experience fear, anxiety, and pain during pelvic examinations. Studies also show that women experience pelvic examinations as uncomfortable, intrusive, embarrassing, humiliating, and upsetting. A study conducted in Turkey reported that women experienced intense anxiety during a pelvic examination and that the most important reason for anxiety was the disruption of privacy. A study conducted in Denmark reported that 75% of women experienced negative emotions during a pelvic examination. Similarly, a study conducted in the Netherlands reported that women felt pain and embarrassment during a pelvic examination, were unable to relax, and were treated disrespectfully. Women may be embarrassed by the exposure of their genitals, a bad smell, or looking dirty during the examination. On the other hand, they may fear that a pathological condition may be discovered. Losing control over their bodies and giving information about their sexual habits are also noteworthy among other reasons for anxiety. Patient-related risk factors for a negative pelvic examination experience include young age, having a male examiner, receiving negative information from peers, previous negative experiences during a pelvic examination, religious and cultural beliefs, and most importantly, a history of sexual trauma. Healthcare provider-related factors that contribute to a negative pelvic examination experience include performing the pelvic examination hastily, insensitively, and without proper explanations. A trusting relationship between the healthcare provider and patients is a mitigating factor to reduce the negative pelvic examination experience. A negative pelvic examination experience may deter women from returning for follow-up tests, thereby reducing the intended benefit of gynecologic screening. For all these reasons, women's experiences with pelvic examinations and related conditions should be taken into account by healthcare services. Although the pelvic examination is relatively brief, cognitive-behavioral interventions that focus or distract the patient's attention have been shown to be effective in reducing pain and anxiety during brief medical interventions. Reducing pain and anxiety during medical procedures is an important factor in patient satisfaction. Although there are many methods of reducing stress, it is thought that the inexpensive and easily accessible anti-stress ball can be used as a method of distraction. In one study, it was determined that the stress ball reduced anxiety and pain during angiography.

Conditions
Pain Management
Being tested
anti-stress ball
Keywords
pap smear, anti stress ball, pain, anxiety
Medical subject headings
Agnosia, Pain, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anti-stress ballOther

    The women will be given a round, silicone, medium-sized and medium-hard anti-stress ball, and they will be told how to use the stress ball, and they will be asked to squeeze the anti-stress ball throughout the examination, allowing the patients to rest occasionally as they wish. The women will be told to count to 3 as they squeeze the anti-stress ball, then to relax the stress ball and repeat this process.

Study groups in NCT06682052
Study groupRoleWhat they receive
Control groupNo interventionAfter obtaining the consent of the women, the Personal Information Form and the State Anxiety Inventory (STAI) will be filled out and prepared for the examination. The examination table is a stirrup table suitable for examination in the lithotomy position. It can be adjusted according to the height of the woman. When the women are taken to the examination table, a cover will be placed to protect privacy. No intervention other than routine application will be made to the women in the control group. After the Pap smear test is completed, the "State Anxiety Inventory (STAI)" and the "Visual Analog Scale (VAS)" will be applied.
Group to be applied anti-stress ballExperimentalAfter the women's consent is obtained, the Personal Information Form and State Anxiety Inventory (STAI) will be filled out and prepared for the examination. The examination table is a stirrup table suitable for examination in the lithotomy position. It can be adjusted according to the woman's height. When the women are taken to the examination table, a cover will be placed to protect privacy. The women will be given a round, silicone, medium-sized and medium-hard anti-stress ball, and they will be told how to use the stress ball, and they will be asked to squeeze the anti-stress ball throughout the examination, allowing the patients to rest occasionally as they wish. The women will be told to count to 3 as they squeeze the anti-stress ball, then to relax the stress ball and repeat this process. After the Pap smear test is completed, the "State Anxiety Inventory (STAI)" and the "Visual Analog Scale (VAS)" will be applied.
Receives: Other: anti-stress ball

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analog Scale

    Visual Analog Scale for pain

    Measured: during application (average 2nd minute)

Secondary outcomes (1)
  1. State Anxiety Inventory (STAI):

    It was designed by Spielberger et al. (1983) to measure state anxiety, which refers to how one feels at the moment, and trait anxiety, which refers to how one feels in general. The State Anxiety Inventory consists of 20 self-reported 4-point Likert-type items, with negatively worded items reverse scored. Total scores range from 20 to 80, with higher scores indicating increased levels of anxiety. The Turkish adaptation of the scale was made by Öner and Le Compte (1983). In studies conducted with different samples, reliability coefficients of the State Anxiety Inventory have been reported between 0.83 and 0.92.

    Measured: after and before procedure (average 5nd minute before and after)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2024
  2. Study start20 Dec 2024 (estimated)
  3. Primary completion15 Feb 2025 (estimated)
  4. Study completion15 Mar 2025 (estimated)

Resources

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
Factorial
Masking
Single blind
Who is masked
Participant
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06682052
Sponsor's protocol ID
Pap_smear_test
Other IDs
Hitit Uni Non-Interventional
Status last verified
Nov 2024
First submitted
7 Nov 2024
Last updated
12 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing anti-stress ball in people with Pain Management, run by Hitit University.

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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fatma Yıldırım Dr (05466742445, fatmadmryldrm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (time frame: during application (average 2nd minute)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 12 Nov 2024.

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