The Effect of Stress Ball Used During Intra Uterine Insemination on Pain, Anxiety, Comfort and Physiological Parameters
NCT ID: NCT06759337
Last Updated: 2025-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2024-10-01
2025-06-30
Brief Summary
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Detailed Description
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To alleviate acute pain and enhance comfort during IUI procedures, in addition to medical interventions, non-pharmacological methods with minimal side effects are also critical (Stewart and Cox-Davenport, 2015). One such approach is the attention distribution method, which enables brain receptors to shift focus away from painful stimuli, thereby reducing pain perception and improving control (Elmali and Balcı Akpinar, 2017). The use of stress balls as a non-pharmacological method of attention distribution is particularly noteworthy. Stress balls are accessible, cost-effective, and safe. Furthermore, their use offers a holistic approach, incorporating touch, healing, and therapeutic effects (Yanes et al., 2018). A review of the literature reveals various findings on the psychometric and vital sign changes-such as anxiety, stress, comfort, and compliance-associated with stress ball use during medical procedures, including colonoscopy, endoscopy, extracorporeal shock wave lithotripsy (ESWL), prostate biopsy, radiography, hemodialysis, intravenous (IV) procedures, and polymerase chain reaction (PCR) testing (Apaydin Cirik et al., 2023; Çakır and Evirgen, 2023; Özen et al., 2023; Karataş and Gezginci, 2023, 2022; Gezginci et al., 2018a; Karataş and Gezginci, 2018; Quan et al., 2016). Additionally, some studies highlight the therapeutic or healing benefits of touch in children and intensive care settings (Garrett and Riou, 2021). However, the specific effects of hand-holding and stress ball use on pain, anxiety, comfort, and physiological parameters during the IUI procedure have not yet been thoroughly investigated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Stress Ball Group
Participants are given a colored silicone stress ball (5-7 cm diameter) 5 minutes before the procedure. During the procedure, they are instructed to squeeze the ball twice after counting to 10 and repeat this until the procedure is complete.
Stress Ball Group
Participants are given a colored silicone stress ball (5-7 cm diameter) 5 minutes before the procedure. During the procedure, they are instructed to squeeze the ball twice after counting to 10 and repeat this until the procedure is complete.
Hand Holding/ Therapeutic Touch Group
The researcher holds one of the participant's hands during catheter insertion and removal. The researcher's fingers are closed but not interlocked and placed gently on the participant's hand without additional movements or gloves.
Hand-Holding Group
The researcher holds one of the participant's hands during catheter insertion and removal. The researcher's fingers are closed but not interlocked and placed gently on the participant's hand without additional movements or gloves.
Control Group
Participants receive no additional intervention beyond the standard routine procedures.
No interventions assigned to this group
Interventions
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Stress Ball Group
Participants are given a colored silicone stress ball (5-7 cm diameter) 5 minutes before the procedure. During the procedure, they are instructed to squeeze the ball twice after counting to 10 and repeat this until the procedure is complete.
Hand-Holding Group
The researcher holds one of the participant's hands during catheter insertion and removal. The researcher's fingers are closed but not interlocked and placed gently on the participant's hand without additional movements or gloves.
Eligibility Criteria
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Inclusion Criteria
1. Agreeing to participate in the study with verbal and written consent,
2. Being between the ages of 18-50,
3. Being able to read and write in Turkish,
4. Not having a muscle or joint problem that prevents squeezing the stress ball
5. Having Intrauterine Insemination (insemination) as an infertility treatment,
Intervention Group 2 (Hand Holding Group)
1. Agreeing to participate in the study with verbal and written consent,
2. Being between the ages of 18-50,
3. Being able to read and write in Turkish,
4. Not having a problem with holding hands
5. Having Intrauterine Insemination (insemination) as an infertility treatment,
Control Group
1. Agreeing to participate in the study with verbal and written consent,
2. Being between the ages of 18-50,
3. Being able to read and write in Turkish,
4. Having Intrauterine Insemination (insemination) as an infertility treatment, To have an insemination (vaccination) procedure,
Exclusion Criteria
1. Use any analgesic agent at least 24 hours before the procedure,
2. Having a chronic pain disorder,
3. Abandoning the completion of the data collection forms,
4. Needing urgent intervention by a physician during or immediately after the procedure,
5. Having any psychiatric disease,
6. Having a visual, hearing, speech, physical or mental disability,
7. Wanting to leave the study at any stage,
8. Not applying the stress ball application as requested
Intervention Group (Hand Holding Group)
1. Use any analgesic agent at least 24 hours before the procedure,
2. Having a chronic pain disorder,
3. Being uncomfortable with the hand-holding application,
4. Abandoning the completion of the data collection forms,
5. Needing urgent intervention by a physician during or immediately after the procedure,
6. Having any psychiatric disease,
7. Having visual, hearing, speech, having a physical or mental disability,
8. Wanting to leave the study at any stage,
Control Group
1. Use any analgesic agent at least 24 hours before the procedure,
2. Having a chronic pain disorder,
3. Stopping the completion of the data collection forms,
4. Needing urgent intervention by a physician during or immediately after the procedure,
5. Having any psychiatric disease,
6. Having a visual, hearing, speech, physical or mental disability,
7. Wanting to leave the study at any stage,
18 Years
50 Years
FEMALE
No
Sponsors
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TC Erciyes University
OTHER
Responsible Party
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Emine Özge AVCI
mSc, nurse
Principal Investigators
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Hümeyra TÜLEK DENİZ, MSc
Role: PRINCIPAL_INVESTIGATOR
Kafkas University
Locations
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Erciyes University Medical Faculty Hospital IVF Unit
Kayseri, Melikgazi, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Cakir SK, Evirgen S. Three Distraction Methods for Pain Reduction During Colonoscopy: A Randomized Controlled Trial Evaluating the Effects on Pain and Anxiety. J Perianesth Nurs. 2023 Oct;38(5):e1-e7. doi: 10.1016/j.jopan.2023.02.007. Epub 2023 Aug 10.
Elmali H, Balci Akpinar R. The effect of watching funny and unfunny videos on post-surgical pain levels. Complement Ther Clin Pract. 2017 Feb;26:36-41. doi: 10.1016/j.ctcp.2016.11.003. Epub 2016 Nov 9.
Garrett B, Riou M. A rapid evidence assessment of recent therapeutic touch research. Nurs Open. 2021 Sep;8(5):2318-2330. doi: 10.1002/nop2.841. Epub 2021 Mar 20.
Genc H, Korkmaz M, Akkurt A. The Effect of Virtual Reality Glasses and Stress Balls on Pain and Vital Findings During Transrectal Prostate Biopsy: A Randomized Controlled Trial. J Perianesth Nurs. 2022 Jun;37(3):344-350. doi: 10.1016/j.jopan.2021.09.006. Epub 2022 Apr 7.
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.
Gezginci E, Iyigun E, Yalcin S, Bedir S, Ozgok IY. Comparison of Two Different Distraction Methods Affecting the Level of Pain and Anxiety during Extracorporeal Shock Wave Lithotripsy: A Randomized Controlled Trial. Pain Manag Nurs. 2018 Jun;19(3):295-302. doi: 10.1016/j.pmn.2017.09.005. Epub 2017 Dec 14.
Karatas TC, Gezginci E. The Effect of Using a Stress Ball During Endoscopy on Pain, Anxiety, and Satisfaction: A Randomized Controlled Trial. Gastroenterol Nurs. 2023 Jul-Aug 01;46(4):309-317. doi: 10.1097/SGA.0000000000000739. Epub 2023 May 17.
Ozen N, Berse S, Tosun B. Effects of using a stress ball on anxiety and depression in patients undergoing hemodialysis: A prospective, balanced, single-blind, crossover study. Hemodial Int. 2023 Oct;27(4):411-418. doi: 10.1111/hdi.13102. Epub 2023 Jun 15.
Sadeghi T, Mohammadi N, Shamshiri M, Bagherzadeh R, Hossinkhani N. Effect of distraction on children's pain during intravenous catheter insertion. J Spec Pediatr Nurs. 2013 Apr;18(2):109-14. doi: 10.1111/jspn.12018. Epub 2013 Mar 5.
Shekhar S, Suprabha BS, Shenoy R, Rao A, Rao A. Effect of active and passive distraction techniques while administering local anaesthesia on the dental anxiety, behaviour and pain levels of children: a randomised controlled trial. Eur Arch Paediatr Dent. 2022 Jun;23(3):417-427. doi: 10.1007/s40368-022-00698-7. Epub 2022 Mar 10.
Quan X, Joseph A, Nanda U, Moyano-Smith O, Kanakri S, Ancheta C, Loveless EA. Improving Pediatric Radiography Patient Stress, Mood, and Parental Satisfaction Through Positive Environmental Distractions: A Randomized Control Trial. J Pediatr Nurs. 2016 Jan-Feb;31(1):e11-22. doi: 10.1016/j.pedn.2015.08.004. Epub 2015 Sep 26.
Stewart M, Cox-Davenport RA. Comparative Analysis of Registered Nurses' and Nursing Students' Attitudes and Use of Nonpharmacologic Methods of Pain Management. Pain Manag Nurs. 2015 Aug;16(4):499-502. doi: 10.1016/j.pmn.2014.09.010. Epub 2014 Dec 12.
Vaajoki A, Pietila AM, Kankkunen P, Vehvilainen-Julkunen K. Effects of listening to music on pain intensity and pain distress after surgery: an intervention. J Clin Nurs. 2012 Mar;21(5-6):708-17. doi: 10.1111/j.1365-2702.2011.03829.x. Epub 2011 Aug 15.
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.
Yilmaz D, Gunes UY. The effect on pain of three different nonpharmacological methods in peripheral intravenous catheterisation in adults. J Clin Nurs. 2018 Mar;27(5-6):1073-1080. doi: 10.1111/jocn.14133. Epub 2018 Jan 8.
Zielinski 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.
Other Identifiers
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Erciyes University
Identifier Type: OTHER
Identifier Source: secondary_id
2024/148
Identifier Type: -
Identifier Source: org_study_id
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