Infertility Assisted Reproductive TechnologyNCT06759337
The Effect of Stress Ball Used During Intra Uterine Insemination on Pain, Anxiety, Comfort and Physiological Parameters
A study testing Stress Ball Group and Hand-Holding Group in people with Infertility Assisted Reproductive Technology and Infertility, Female, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Infertility Assisted Reproductive Technology, Infertility, Female
- What is being tested?
- Stress Ball Group and Hand-Holding Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2024to 1 Apr 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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,
Show all 17Show fewer
- 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,
Who cannot join
- 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,
Show all 26Show fewer
- 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,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University Medical Faculty Hospital IVF Unit
Kayseri, Melikgazi, 38039
About this study
Official title: The Effect of Stress Ball Used During Intra Uterine Insemination on Pain, Anxiety, Comfort and Physiological Parameters: A Randomized Controlled Study
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.
Read the 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.
- Being tested
- Stress Ball Group, Hand-Holding Group
- Keywords
- Assisted Reproductive Techniques, Stress Ball, Pain, Anxiety, Comfort, Physiological Parameters, infertility
- Medical subject headings
- Infertility, Female, Pain, Anxiety Disorders, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Ball GroupBehavioural
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 GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Stress Ball Group | Experimental | 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. Receives: Behavioral: Stress Ball Group |
| Hand Holding/ Therapeutic Touch Group | Experimental | 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. Receives: Behavioral: Hand-Holding Group |
| Control Group | No intervention | Participants receive no additional intervention beyond the standard routine procedures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form
This form, which includes the characteristics of the patients, consists of 10 questions, including age, education level, marital status, employment status, income level, type of infertility, duration of infertility problem, and cause of infertility. The patient's physiological parameters (pulse, respiration, systolic blood pressure (SBP), diastolic blood pressure (DBP), and oxygen saturation values (SpO2) before and after the procedure will also be recorded using this form.
Measured: 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
It will be used to determine the pain intensity experienced by infertile women during IUI. The pain level varies between 0-10, and the 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 (Zielinski et al., 2020).
Measured: 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
The scale Spielberger et al. (1970) developed to measure the individual's state and trait anxiety level, reliability, and validity in Turkish was conducted by Öner and Le Compte (1983). The scale measures anxiety. It consists of two sub-units that are measured separately: state anxiety requires the individual to describe how they feel at a certain moment and under certain conditions, and trait anxiety requires the individual to describe how they generally feel. In this study, the state anxiety scale will be used since the anxiety that the individual feels indirectly from the stressful situation they are in will be evaluated. The total score obtained from the scale varies between 20 and 80, with a high score indicating a high level of anxiety.
Measured: 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
The Kolcaba (2006) scale was developed to measure patients' comfort. The scale consists of 28 items in 6-point Likert type in 3 sub-dimensions: relief (9), relaxation (9), and overcoming problems sub-dimension (10 items). The highest total score from the scale is 168 points; the lowest total score is 28 points (Çıtlık et al., 2018)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start30 Dec 2024
- Primary completion31 Mar 2025
- Study completion1 Apr 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 Infertility Assisted Reproductive TechnologyStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Özge AVCI, TC Erciyes University
- Investigators
- Hümeyra TÜLEK DENİZ, MSc, Principal investigator, Kafkas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759337
- Sponsor's protocol ID
- 2024/148
- Other IDs
- Erciyes University
- Status last verified
- Oct 2026
- First submitted
- 28 Dec 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There has been no planning on this matter.
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 36526480Cakir 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.
PubMed 37565937Elmali 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.
PubMed 28107847Garrett 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.
PubMed 33742792Genc 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.
PubMed 35397973Gezginci 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 30280915Gezginci 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.
PubMed 29248604Karatas 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.
PubMed 37199436Ozen 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.
PubMed 37318078Sadeghi 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.
PubMed 23560582Shekhar 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.
PubMed 35274286Quan 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.
PubMed 26395650Stewart 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.
PubMed 25499026Vaajoki 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.
PubMed 21843204Yanes 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 30027283
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stress Ball Used During Intra Uterine Insemination on Pain, Anxiety, Comfort and Physiological Parameters: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06759337
- Acronym / sponsor ID
- 2024/148
- Keywords
- Assisted Reproductive Techniques, Stress Ball, Pain, Anxiety, Comfort, Physiological Parameters, infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 6 Jan 2025 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stress Ball Group | Experimental | Behavioral: Stress Ball GroupParticipants 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 | Experimental | Behavioral: Hand-Holding GroupThe 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 | No intervention | –Participants receive no additional intervention beyond the standard routine procedures. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (26 listed)
- 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,
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 GroupParticipants 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. | Behavioural | Stress Ball Group |
| Hand-Holding GroupThe 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. | Behavioural | Hand Holding/ Therapeutic Touch Group |
Primary outcome
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.
This form, which includes the characteristics of the patients, consists of 10 questions, including age, education level, marital status, employment status, income level, type of infertility, duration of infertility problem, and cause of infertility. The patient's physiological parameters (pulse, respiration, systolic blood pressure (SBP), diastolic blood pressure (DBP), and oxygen saturation values (SpO2) before and after the procedure will also be recorded using this form.
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.
It will be used to determine the pain intensity experienced by infertile women during IUI. The pain level varies between 0-10, and the 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 (Zielinski et al., 2020).
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.
The scale Spielberger et al. (1970) developed to measure the individual's state and trait anxiety level, reliability, and validity in Turkish was conducted by Öner and Le Compte (1983). The scale measures anxiety. It consists of two sub-units that are measured separately: state anxiety requires the individual to describe how they feel at a certain moment and under certain conditions, and trait anxiety requires the individual to describe how they generally feel. In this study, the state anxiety scale will be used since the anxiety that the individual feels indirectly from the stressful situation they are in will be evaluated. The total score obtained from the scale varies between 20 and 80, with a high score indicating a high level of anxiety.
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.
The Kolcaba (2006) scale was developed to measure patients' comfort. The scale consists of 28 items in 6-point Likert type in 3 sub-dimensions: relief (9), relaxation (9), and overcoming problems sub-dimension (10 items). The highest total score from the scale is 168 points; the lowest total score is 28 points (Çıtlık et al., 2018)
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 3 Nov 2026.
- 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 37565937Cakir 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.
- Background: PubMed 28107847Elmali 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.
- Background: PubMed 33742792Garrett 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.
- Background: PubMed 35397973Genc 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.
- 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 29248604Gezginci 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.
- Background: PubMed 37199436Karatas 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.
- Background: PubMed 37318078Ozen 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.
- Background: PubMed 23560582Sadeghi 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.
- Background: PubMed 35274286Shekhar 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.
- Background: PubMed 26395650Quan 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.
- Individual participant dataSharing planned: No. There has been no planning on this matter.
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Infertility Assisted Reproductive Technology
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.
Hümeyra TÜLEK DENİZ, MSc principal investigator
Kafkas 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 Group and Hand-Holding Group in people with Infertility Assisted Reproductive Technology and Infertility, Female, run by TC Erciyes 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 17 inclusion and 26 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 3 Nov 2026. 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?
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.). The study lists 4 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 NCT06759337, 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 3 Nov 2026.