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RECRUITING

NCT06759337

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

Sponsor: TC Erciyes University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-10-01

Completion Date

2025-06-30

Last Updated

2025-01-06

Healthy Volunteers

Conditions

Infertility Assisted Reproductive Technology Infertility, Female

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Inclusion Criteria: Intervention Group 1 (Stress Ball Group) 1. Agreeing to participate in the study with verbal and written consent, 2. Being between the ages of 18-50, 3. Being able to read and write in Turkish, 4. Not having a muscle or joint problem that prevents squeezing the stress ball 5. Having Intrauterine Insemination (insemination) as an infertility treatment, Intervention Group 2 (Hand Holding Group) 1. Agreeing to participate in the study with verbal and written consent, 2. Being between the ages of 18-50, 3. Being able to read and write in Turkish, 4. Not having a problem with holding hands 5. Having Intrauterine Insemination (insemination) as an infertility treatment, Control Group 1. Agreeing to participate in the study with verbal and written consent, 2. Being between the ages of 18-50, 3. Being able to read and write in Turkish, 4. Having Intrauterine Insemination (insemination) as an infertility treatment, To have an insemination (vaccination) procedure, Exclusion Criteria: Intervention Group (Stress Ball Group) 1. Use any analgesic agent at least 24 hours before the procedure, 2. Having a chronic pain disorder, 3. Abandoning the completion of the data collection forms, 4. Needing urgent intervention by a physician during or immediately after the procedure, 5. Having any psychiatric disease, 6. Having a visual, hearing, speech, physical or mental disability, 7. Wanting to leave the study at any stage, 8. Not applying the stress ball application as requested Intervention Group (Hand Holding Group) 1. Use any analgesic agent at least 24 hours before the procedure, 2. Having a chronic pain disorder, 3. Being uncomfortable with the hand-holding application, 4. Abandoning the completion of the data collection forms, 5. Needing urgent intervention by a physician during or immediately after the procedure, 6. Having any psychiatric disease, 7. Having visual, hearing, speech, having a physical or mental disability, 8. Wanting to leave the study at any stage, Control Group 1. Use any analgesic agent at least 24 hours before the procedure, 2. Having a chronic pain disorder, 3. Stopping the completion of the data collection forms, 4. Needing urgent intervention by a physician during or immediately after the procedure, 5. Having any psychiatric disease, 6. Having a visual, hearing, speech, physical or mental disability, 7. Wanting to leave the study at any stage,

Locations (1)

Erciyes University Medical Faculty Hospital IVF Unit

Kayseri, Melikgazi, Turkey (Türkiye)