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New treatment option for Infertility Assisted Reproductive Technology
Official title The Effect of Stress Ball Used During Intra Uterine Insemination on Pain, Anxiety, Comfort and Physiological Parameters
ClinicalTrials.gov ID: NCT06759337
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only
You may be able to join if
- 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
You likely can't join if
- 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,
See the full eligibility 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,
- 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,
The study team makes the final eligibility decision.
Where it's taking place
- Kayseri, Melikgazi, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kayseri, Melikgazi, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.