RecruitingNot ApplicableNCT06759337

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

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


Sponsor

TC Erciyes University

Enrollment

120 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing whether squeezing a stress ball or having a nurse hold your hand during intrauterine insemination (IUI) — a fertility treatment where sperm is placed directly into the uterus — can reduce pain, anxiety, and discomfort during the procedure. **You may be eligible if...** - You are a woman between 18 and 50 years old - You are undergoing IUI as a fertility treatment - You can read and write Turkish - You can physically squeeze a stress ball or tolerate hand-holding (depending on the group) **You may NOT be eligible if...** - You have taken pain medication within 24 hours before the procedure - You have a chronic pain disorder - You have a psychiatric illness or significant disability - You need emergency medical care during the procedure - You decide to withdraw from the study at any point Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALStress 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.

BEHAVIORALHand-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.


Locations(1)

Erciyes University Medical Faculty Hospital IVF Unit

Kayseri, Melikgazi, Turkey (Türkiye)

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NCT06759337


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