Using a stress ball during Intrauterine Insemination to reduce pain and anxiety

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

This study is testing if using a stress ball or having someone hold your hand can help women feel less pain and anxiety during the Intrauterine Insemination (IUI) procedure.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Female
• Sponsor: TC Erciyes University (Academic / other)
• Locations: 1 site (Kayseri, Melikgazi)
• Trial ID: NCT06759337 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of holding a stress ball and hand-holding during the Intrauterine Insemination (IUI) procedure on patients' pain, anxiety, comfort, and physiological parameters. Conducted as a randomized controlled trial, it will involve 120 women divided into three groups: one using a stress ball, one receiving hand-holding support, and a control group. Data will be collected through various scales to assess pain and anxiety levels before and after the procedure. The aim is to explore non-pharmacological methods to enhance patient comfort during IUI.

Who should consider this trial

Good fit: Ideal candidates are women aged 18-50 who are undergoing Intrauterine Insemination as a treatment for infertility.

Not a fit: Patients with muscle or joint problems that prevent them from squeezing a stress ball or holding hands may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce pain and anxiety for women undergoing IUI, improving their overall experience.

How similar studies have performed: While the use of non-pharmacological methods like stress balls is promising, this specific approach has not been extensively tested in similar studies.

Eligibility criteria

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,

Where this trial is running

Kayseri, Melikgazi

• Erciyes University Medical Faculty Hospital IVF Unit — Kayseri, Melikgazi, Turkey (Türkiye) (Recruiting)

Study contacts

• Principal investigator: Hümeyra TÜLEK DENİZ, MSc — Kafkas University
• Study coordinator: Hümeyra TÜLEK DENİZ, MSc

Conditions Infertility Assisted Reproductive Technology; Infertility, Female; Assisted Reproductive Techniques; Stress Ball; Pain; Anxiety; Comfort; Physiological Parameters