Actively Recruiting
The Effect of Stress Ball Used During Intra Uterine Insemination on Pain, Anxiety, Comfort and Physiological Parameters
Led by TC Erciyes University · Updated on 2025-01-06
120
Participants Needed
1
Research Sites
38 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effect of Stress Ball Used During Intra Uterine Insemination on Pain, Anxiety, Comfort and Physiological Parameters
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Not having a muscle or joint problem that prevents squeezing the stress ball (Stress Ball Group only)
- Not having a problem with holding hands (Hand Holding Group only)
You will not qualify if you...
- Using 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 (Stress Ball Group only)
- Being uncomfortable with the hand-holding application (Hand Holding Group only)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Erciyes University Medical Faculty Hospital IVF Unit
Kayseri, Melikgazi, Turkey (Türkiye), 38039
Actively Recruiting
Research Team
H
Hümeyra TÜLEK DENİZ, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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