The Effect of Using a Stress Ball During Vaginal Examination on Anxiety and Pain Levels: a Randomized Controlled Study

March 19, 2025 updated by: Nedime Gul Dogan Ozdemir, Ondokuz Mayıs University

The Effect of Using a Stress Ball During Vaginal Examination on Anxiety and Pain Levels

Women who will undergo vaginal examinations randomly assigned to intervention (n = 44) and control (n = 44) groups at a public hospital in Turkey will participate in the study. Stress ball application before vaginal examination will be explained to women in the intervention group. These women will be asked to tighten and loosen the stress ball given to them during the vaginal examination and continue this process until the examination is completed. Data regarding pain and anxiety outcomes will be collected before and after the examination.

The main questions it aims to answer are:

  • question 1: What is the effect of stress ball application on women's anxiety level during vaginal examination?
  • question 2: What is the effect of stress ball application on women's pain level during vaginal examination?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Although vaginal examinations take less time than all other medical interventions, they create anxiety and negative thoughts in women. However, the vaginal examination has an important place in women's health as it helps detect sexually transmitted diseases, oncological processes, and all other changes early. Women shy away from gynecological examinations or postpone the examination due to the meanings they attach to gynecological examination and their physical or psychological negative experiences. This situation causes changes in the woman's health not to be detected early and to the emergence of negative consequences. For this reason, vaginal examination should not be performed in a way that increases the woman's anxiety, and methods that will facilitate the examination process should be used . Women state that they feel defenseless and that they hand over complete control to the person examining their reproductive organs, which they prefer to share only with their sexual partners . In a study evaluating the degree of physical discomfort during gynecological examination on a scale from 0 to 10, women defined the pain they experienced as six or more points. Other studies report that women have a more positive experience when techniques such as relaxation exercises, listening to music, or aromatherapy are used before or during vaginal examination. In addition to these techniques, visual, auditory, or tactile stimuli can focus women in a calmer state. Tactile stimuli, in particular, have the most effortless and natural potential for reducing anxiety or pain. The stress ball, one of the tactile stimuli, is thought to be an easy-to-use, non-invasive, non-pharmacological, inexpensive, and easily accessible method that helps the person focus elsewhere by distracting attention. Healthcare professionals need to reduce people's anxiety and ensure their comfort by developing positive coping mechanisms. Especially during the vaginal examination process, which is considered private in society, the majority of women expect nurses to be understanding and gentle and to know the methods that will make the woman feel comfortable. Lavender oil, one of the non-pharmacological applications during vaginal examination, has been shown to reduce anxiety and pain, and studies are comparing its positive effect. However, there is a need to investigate this, as there are no studies investigating the effectiveness of non-pharmacological methods of vaginal examination, especially the stress ball. No studies have been found. Although there are studies in the literature investigating the effectiveness of the stress ball, one of the non-pharmacological methods, in the treatment of various disease groups and symptoms , vaginal examination. No study has been found examining the effectiveness of a stress ball during exercise.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Samsun, Turkey, 55220
        • Ondokuz Mayıs University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Volunteer to participate in the research,
  • Those between the ages of 18-65,
  • Applying to the polyclinic for vaginal examination,
  • It is planned to recruit women who can read and write Turkish.

Exclusion Criteria:

  • Pregnant,
  • Having a diagnosed psychiatric problem such as depression, anxiety disorder, panic attack, bipolar affective disorder or schizophrenia
  • It is planned to exclude women with visual, hearing, speech, physical, or mental disabilities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
No intervention other than usual care
Experimental: Intervention group
Received stress ball intervention and usual care
Behavioral: Stress ball intervention
Women should squeeze and loosen the stress ball given to them during the vaginal examination and continue this process until the examination is completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety change
Time Frame: Immediately after the intervention
As assessed by the State-Trait Anxiety Inventory (STAI) STAI consists of two scales, a total of 40 self-reported items. The State Anxiety Scale only used in this study, consists of 20 straight and inverse scored terms, and is scored between 20 and 80 in a likert type scoring between 1 and 4. High scores indicate high anxiety levels.
Immediately after the intervention
Pain level
Time Frame: Immediately after the intervention
Visual Analog Scale (VAS) will be used to determine the severity of pain experienced by women in the intervention and control groups during vaginal examination. VAS converts values that cannot be measured numerically into numerical values. This scale is widely used for pain assessment. The pain level varies between 0 and 10, and an increase in the marked numerical value indicates an increase in the pain level. In the VAS evaluation, 0 = no pain, 1-4 = mild pain, 5-6 = moderate pain, and 7-10 = severe pain.
Immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ondokuz Mayıs University

Investigators

  • Principal Investigator: Nedime Gül DOĞAN ÖZDEMİR, Ondokuz Mayıs University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2024

Primary Completion (Actual)

December 10, 2024

Study Completion (Actual)

March 7, 2025

Study Registration Dates

First Submitted

January 31, 2024

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 19, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5535

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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