Stress Balls in Gynecologic Exams: A Patient Comfort Trial

Istanbul University - Cerrahpasa141 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

141

Conditions

Gynecologic

Interventions

Stress BallBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Ağrı Training and Research Hospital

Ağrı, Ağrı, Turkey (Türkiye)

Outcomes

Primary Outcomes

Pain intensity during Pap smear procedure

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

Time frame: Immediately after the Pap smear procedure

Secondary Outcomes

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.

Time frame: 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.

Time frame: Immediately after the Pap smear procedure

Data from ClinicalTrials.gov

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