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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
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⁃ 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,

Locations
Other Locations
Turkey
Erciyes University Medical Faculty Hospital IVF Unit
RECRUITING
Kayseri
Contact Information
Primary
Hümeyra TÜLEK DENİZ, MSc
humeyra.tulek@kafkas.edu.tr
+90 474 242 68 40
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 120
Treatments
Experimental: 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.
Experimental: Hand Holding/ Therapeutic Touch 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.
No_intervention: Control Group
Participants receive no additional intervention beyond the standard routine procedures.
Related Therapeutic Areas
Sponsors
Leads: TC Erciyes University

This content was sourced from clinicaltrials.gov