The Effect of Stress Ball Used During Intra Uterine Insemination on Pain, Anxiety, Comfort and Physiological Parameters

Official title

The Effect of Stress Ball Used During Intra Uterine Insemination on Pain, Anxiety, Comfort and Physiological Parameters: A Randomized Controlled Study

Overview

This study aimed to determine the effects of holding the patient's hand and using a stress ball during the Intrauterine Insemination procedure on pain, anxiety, comfort, and physiological parameters. This study will be conducted as a randomized controlled trial with a pre-test-post-test procedure in the IVF Unit of a Medical Faculty Hospital in Turkey. The study sample was planned to include 120 participants, 40 women each in the stress ball, hand-holding, and control groups. Data will be collected using the Personal Information Form, Visual Analog Scale, State Anxiety Inventory, and General Comfort Scale Short Form. In the 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. In the 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. In the Control Group, Participants receive no additional intervention beyond the standard routine procedures.

Detailed description

Infertility is a significant social and health issue, negatively affecting couples, particularly women's biological, physical, and psychosocial well-being. Assisted reproductive techniques are utilized to help couples with infertility achieve parenthood (Taşkın, 2023). Among these techniques, the Intrauterine Insemination (IUI) procedure can lead to pain, anxiety, discomfort, and trauma, both from the procedure itself and from the emotional impact of infertility. Pain associated with trauma and anxiety may trigger adverse effects, such as increased catecholamine levels, reduced heart rate, blood pressure, and lung vital capacity, due to the activation of the sympathetic nervous system (Yıldız Fındık and Soydaş Yeşilyurt, 2017; Vaajoki et al., 2012).

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.

Interventions

• Behavioral 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.
• Behavioral 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.

Primary outcome measures

• Personal Information Form [Time frame: The researcher will apply 10 minutes before the IUI procedure and 15 minutes after the procedure to women who are kept under observation in the patient monitoring room after the IUI procedure.]
• Visual Analog Scale [Time frame: The researcher will apply 10 minutes before the IUI procedure and 15 minutes after the procedure to women who are kept under observation in the patient monitoring room after the IUI procedure.]
• State Anxiety Inventory [Time frame: The researcher will apply 10 minutes before the IUI procedure and 15 minutes after the procedure to women who are kept under observation in the patient monitoring room after the IUI procedure.]
• General Comfort Scale Short Form [Time frame: The researcher will apply 10 minutes before the IUI procedure and 15 minutes after the procedure to women who are kept under observation in the patient monitoring room after the IUI procedure.]

Eligibility criteria

Inclusion criteria

Intervention Group 1 (Stress Ball Group)

• Agreeing to participate in the study with verbal and written consent,
• Being between the ages of 18-50,
• Being able to read and write in Turkish,
• Not having a muscle or joint problem that prevents squeezing the stress ball
• Having Intrauterine Insemination (insemination) as an infertility treatment,

Intervention Group 2 (Hand Holding Group)

• Agreeing to participate in the study with verbal and written consent,
• Being between the ages of 18-50,
• Being able to read and write in Turkish,
• Not having a problem with holding hands
• Having Intrauterine Insemination (insemination) as an infertility treatment,

Control Group

• Agreeing to participate in the study with verbal and written consent,
• Being between the ages of 18-50,
• Being able to read and write in Turkish,
• Having Intrauterine Insemination (insemination) as an infertility treatment, To have an insemination (vaccination) procedure,

Exclusion criteria

Intervention Group (Stress Ball Group)

• Use any analgesic agent at least 24 hours before the procedure,
• Having a chronic pain disorder,
• Abandoning the completion of the data collection forms,
• Needing urgent intervention by a physician during or immediately after the procedure,
• Having any psychiatric disease,
• Having a visual, hearing, speech, physical or mental disability,
• Wanting to leave the study at any stage,
• Not applying the stress ball application as requested

Intervention Group (Hand Holding Group)

• Use any analgesic agent at least 24 hours before the procedure,
• Having a chronic pain disorder,
• Being uncomfortable with the hand-holding application,
• Abandoning the completion of the data collection forms,
• Needing urgent intervention by a physician during or immediately after the procedure,
• Having any psychiatric disease,
• Having visual, hearing, speech, having a physical or mental disability,
• Wanting to leave the study at any stage,

Control Group

• Use any analgesic agent at least 24 hours before the procedure,
• Having a chronic pain disorder,
• Stopping the completion of the data collection forms,
• Needing urgent intervention by a physician during or immediately after the procedure,
• Having any psychiatric disease,
• Having a visual, hearing, speech, physical or mental disability,
• Wanting to leave the study at any stage,

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 1 center

• Erciyes University Medical Faculty Hospital IVF Unit — Kayseri

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. PMID 36526480
• 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. PMID 37565937
• 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. PMID 28107847
• 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. PMID 33742792
• 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. PMID 35397973
• 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
• 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. PMID 29248604
• 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. PMID 37199436

Identifiers

NCT: NCT06759337 · 2024/148 · Erciyes University

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗