Stress Ball Application on Anxiety and Pain During Pap Smear Test

NCT06682052 | Not Yet Recruiting

• 2 other identifiers: Pap_smear_testHitit Uni Non-Interventional
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain Management

Keywords

pap smear; anti stress ball; pain; anxiety

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale

  Visual Analog Scale for pain

  during application (average 2nd minute)

Secondary Outcomes (1)

• State Anxiety Inventory (STAI):

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

Study Arms (2)

Control group

NO INTERVENTION

After 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 ball

EXPERIMENTAL

After 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.

Other: anti-stress ball

Interventions

anti-stress ball OTHER

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.

Group to be applied anti-stress ball

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hitit University: lead

MeSH Terms

Conditions

Agnosia; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Fatma Yıldırım Dr

CONTACT

05466742445; fatmadmryldrm@gmail.com

Study Design

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

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: December 20, 2024
• Primary Completion: February 15, 2025
• Study Completion: March 15, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share