Anxiety StateNCT06263166
The Effect of Using a Stress Ball During Vaginal Examination on Anxiety and Pain Levels: a Randomized Controlled Study
A study testing Stress ball intervention in people with Anxiety State and Pain, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety State, Pain, Exanimation
- What is being tested?
- Stress ball intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2024to 7 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read the 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.
- Conditions
- Anxiety State, Pain, Exanimation
- Being tested
- Stress ball intervention
- Medical subject headings
- Anxiety Disorders, Pain, Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress ball interventionBehavioural
Women should squeeze and loosen the stress ball given to them during the vaginal examination and continue this process until the examination is completed.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No intervention other than usual care |
| Intervention group | Experimental | Received stress ball intervention and usual care Receives: Behavioral: Stress ball intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start20 Mar 2024
- Primary completion10 Dec 2024
- Study completion7 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Anxiety StateStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nedime Gul Dogan Ozdemir, Ondokuz Mayıs University
- Investigators
- Nedime Gül DOĞAN ÖZDEMİR, Principal investigator, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263166
- Sponsor's protocol ID
- 5535
- Status last verified
- Mar 2025
- First submitted
- 31 Jan 2024
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Apaydin Cirik V, Turkmen AS, Ayaz M. Effectiveness of stress ball and relaxation exercises on polymerase chain reaction (RRT-PCR) test-induced fear and pain in adolescents in Turkiye. J Pediatr Nurs. 2023 Jul-Aug;71:135-140. doi: 10.1016/j.pedn.2022.12.001. Epub 2022 Dec 14.
PubMed 36526480Kocabas P, Khorshid L. A comparison of the effects of a special gynaecological garment and music in reducing the anxiety related to gynaecological examination. J Clin Nurs. 2012 Mar;21(5-6):791-9. doi: 10.1111/j.1365-2702.2011.03958.x. Epub 2011 Dec 15.
PubMed 22171649Grundstrom 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.
PubMed 21381979Hilden 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.
PubMed 14616277Lin 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.
PubMed 31698704Yanes 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.
PubMed 30027283Gezginci 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.
PubMed 30280915Hudson 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.
PubMed 25641687Yanikkerem 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.
PubMed 18086509Tugut 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.
PubMed 28779939Haynes 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.
PubMed 35263344Kurt 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.
PubMed 38178322Henrique 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.
PubMed 29512230Zielinski J, Morawska-Kochman M, Zatonski T. Pain assessment and management in children in the postoperative period: A review of the most commonly used postoperative pain assessment tools, new diagnostic methods and the latest guidelines for postoperative pain therapy in children. Adv Clin Exp Med. 2020 Mar;29(3):365-374. doi: 10.17219/acem/112600.
PubMed 32129952Manworren RC, Stinson J. Pediatric Pain Measurement, Assessment, and Evaluation. Semin Pediatr Neurol. 2016 Aug;23(3):189-200. doi: 10.1016/j.spen.2016.10.001. Epub 2016 Oct 17.
PubMed 27989326
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using a Stress Ball During Vaginal Examination on Anxiety and Pain Levels
- ClinicalTrials.gov ID
- NCT06263166
- Acronym / sponsor ID
- 5535
- Conditions
- Anxiety State, Pain, Exanimation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 7 Mar 2025 (actual)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No intervention other than usual care |
| Intervention group | Experimental | Behavioral: Stress ball interventionReceived stress ball intervention and usual care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress ball interventionWomen should squeeze and loosen the stress ball given to them during the vaginal examination and continue this process until the examination is completed. | Behavioural | Intervention group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Background: PubMed 36526480Apaydin Cirik V, Turkmen AS, Ayaz M. Effectiveness of stress ball and relaxation exercises on polymerase chain reaction (RRT-PCR) test-induced fear and pain in adolescents in Turkiye. J Pediatr Nurs. 2023 Jul-Aug;71:135-140. doi: 10.1016/j.pedn.2022.12.001. Epub 2022 Dec 14.
- Background: PubMed 22171649Kocabas P, Khorshid L. A comparison of the effects of a special gynaecological garment and music in reducing the anxiety related to gynaecological examination. J Clin Nurs. 2012 Mar;21(5-6):791-9. doi: 10.1111/j.1365-2702.2011.03958.x. Epub 2011 Dec 15.
- Background: PubMed 21381979Grundstrom 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.
- Background: PubMed 14616277Hilden 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.
- Background: PubMed 31698704Lin 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.
- Background: PubMed 30027283Yanes 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.
- Background: PubMed 30280915Gezginci 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.
- Background: PubMed 25641687Hudson 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.
- Background: PubMed 18086509Yanikkerem 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.
- Background: PubMed 28779939Tugut 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.
- Background: PubMed 35263344Haynes 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.
- Background: PubMed 38178322Kurt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nedime Gül DOĞAN ÖZDEMİR principal investigator
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress ball intervention in people with Anxiety State and Pain, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety change (time frame: Immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06263166, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.