Clinical trial NCT06682052: Stress Ball Application on Anxiety and Pain During Pap Smear Test
Official title: Stress Ball Application on Pap Smear Test
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain Management
Keywords: pap smear
anti stress ball
pain
anxiety
Lead sponsor: Hitit University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: during application (average 2nd minute)
Secondary outcomes:
measure: State Anxiety Inventory (STAI):
timeFrame: after and before procedure (average 5nd minute before and after)
Other outcomes:
Locations:
Study officials:
References: