Stress Balls in Gynecologic Exams: A Patient Comfort Trial

NCT06679231 | Completed

• 1 other identifier: E-95531838-050.99-116026
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief 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 . 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.

Conditions

Gynecologic

Keywords

pain; women health; pap-smear; anxiety

Outcome Measures

Primary Outcomes (1)

• Pain intensity during Pap smear procedure

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

  Immediately after the Pap smear procedure

Secondary Outcomes (2)

• Change in State Anxiety Level

  Immediately after the Pap smear procedure

• Patient Satisfaction with the Gynecological Examination

  Immediately after the Pap smear procedure

Study Arms (2)

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.

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.

Interventions

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.

Stress Ball

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: suitable for women who have had a pap smear
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being between the ages of 18-35,
• Being literate, knowing and understanding Turkish,
• Don't have a pap-smear test for the first time,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Ağrı Training and Research Hospital

Ağrı, Ağrı, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 31882291 BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 7, 2024
• Study Start: December 10, 2024
• Primary Completion: April 7, 2025
• Study Completion: April 8, 2025
• Last Updated: March 3, 2026

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)