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

NCT06263166 | Completed

• 1 other identifier: 5535
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Anxiety State; Pain; Exanimation

Outcome Measures

Primary Outcomes (2)

• Anxiety change

  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

  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

Study Arms (2)

Control group

NO INTERVENTION

No intervention other than usual care

Intervention group

EXPERIMENTAL

Received stress ball intervention and usual care

Behavioral: Stress ball intervention

Interventions

Stress ball intervention BEHAVIORAL

Women should squeeze and loosen the stress ball given to them during the vaginal examination and continue this process until the examination is completed.

Intervention group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs University

Samsun, 55220, Turkey (Türkiye)

Location

Related Publications (17)

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  PMID: 36526480 BACKGROUND

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  PMID: 22171649 BACKGROUND

• Grundstrom H, Wallin K, Bertero C. 'You expose yourself in so many ways': young women's experiences of pelvic examination. J Psychosom Obstet Gynaecol. 2011 Jun;32(2):59-64. doi: 10.3109/0167482X.2011.560692. Epub 2011 Mar 8.

  PMID: 21381979 BACKGROUND

• Hilden M, Sidenius K, Langhoff-Roos J, Wijma B, Schei B. Women's experiences of the gynecologic examination: factors associated with discomfort. Acta Obstet Gynecol Scand. 2003 Nov;82(11):1030-6. doi: 10.1034/j.1600-0412.2003.00253.x.

  PMID: 14616277 BACKGROUND

• Lin CJ, Chang YC, Chang YH, Hsiao YH, Lin HH, Liu SJ, Chao CA, Wang H, Yeh TL. Music Interventions for Anxiety in Pregnant Women: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2019 Nov 6;8(11):1884. doi: 10.3390/jcm8111884.

  PMID: 31698704 BACKGROUND

• Yanes AF, Weil A, Furlan KC, Poon E, Alam M. Effect of Stress Ball Use or Hand-holding on Anxiety During Skin Cancer Excision: A Randomized Clinical Trial. JAMA Dermatol. 2018 Sep 1;154(9):1045-1049. doi: 10.1001/jamadermatol.2018.1783.

  PMID: 30027283 BACKGROUND

• Gezginci E, Iyigun E, Kibar Y, Bedir S. Three Distraction Methods for Pain Reduction During Cystoscopy: A Randomized Controlled Trial Evaluating the Effects on Pain, Anxiety, and Satisfaction. J Endourol. 2018 Nov;32(11):1078-1084. doi: 10.1089/end.2018.0491.

  PMID: 30280915 BACKGROUND

• Hudson BF, Ogden J, Whiteley MS. Randomized controlled trial to compare the effect of simple distraction interventions on pain and anxiety experienced during conscious surgery. Eur J Pain. 2015 Nov;19(10):1447-55. doi: 10.1002/ejp.675. Epub 2015 Jan 30.

  PMID: 25641687 BACKGROUND

• Yanikkerem E, Ozdemir M, Bingol H, Tatar A, Karadeniz G. Women's attitudes and expectations regarding gynaecological examination. Midwifery. 2009 Oct;25(5):500-8. doi: 10.1016/j.midw.2007.08.006. Epub 2007 Dec 20.

  PMID: 18086509 BACKGROUND

• Tugut N, Demirel G, Baser M, Ata EE, Karakus S. Effects of lavender scent on patients' anxiety and pain levels during gynecological examination. Complement Ther Clin Pract. 2017 Aug;28:65-69. doi: 10.1016/j.ctcp.2017.05.006. Epub 2017 May 13. No abstract available.

  PMID: 28779939 BACKGROUND

• Haynes AC, Lywood A, Crowe EM, Fielding JL, Rossiter JM, Kent C. A calming hug: Design and validation of a tactile aid to ease anxiety. PLoS One. 2022 Mar 9;17(3):e0259838. doi: 10.1371/journal.pone.0259838. eCollection 2022.

  PMID: 35263344 BACKGROUND

• Kurt G, Ozcan NK. The Effect of Virtual Reality On Pain and Anxiety Management During Pelvic Examination: A Randomized Controlled Trial. J Midwifery Womens Health. 2024 Jul-Aug;69(4):543-549. doi: 10.1111/jmwh.13587. Epub 2024 Jan 4.

  PMID: 38178322 BACKGROUND

• Henrique AJ, Gabrielloni MC, Rodney P, Barbieri M. Non-pharmacological interventions during childbirth for pain relief, anxiety, and neuroendocrine stress parameters: A randomized controlled trial. Int J Nurs Pract. 2018 Jun;24(3):e12642. doi: 10.1111/ijn.12642. Epub 2018 Mar 7.

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  PMID: 32129952 BACKGROUND

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  PMID: 27989326 BACKGROUND

• Spielberger, C. D., Gonzalez-Reigosa, F., Martinez-Urrutia, A., Natalicio, L. F., & Natalicio, D. S. (1971). The state-trait anxiety inventory. Revista Interamericana de Psicologia/Interamerican journal of psychology, 5(3 & 4).

  BACKGROUND

• Öner, N., & Le Compte, A. (1998). Süreksiz durumluk/sürekli kaygı envanteri el kitabı (2. Baskı). İstanbul: Boğaziçi Üniversitesi, 15-79.

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Pain; Coma

Condition Hierarchy (Ancestors)

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

Study Officials

• Nedime Gül DOĞAN ÖZDEMİR

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

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: Research Assistant

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 16, 2024
• Study Start: March 20, 2024
• Primary Completion: December 10, 2024
• Study Completion: March 7, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)