Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
ID06759337

The Effect of Stress Ball Use and Hand-Holding During Intrauterine Insemination on Pain, Anxiety, Comfort, and Physiological Parameters A Randomized Controlled Study

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

Researchers are evaluating the effects of using a stress ball and hand-holding during the Intrauterine Insemination (IUI) procedure on pain, anxiety, comfort, and physiological responses. This randomized controlled trial includes 120 women undergoing IUI treatment at a medical faculty hospital in Turkey. The study compares three groups: those using a stress ball, those receiving hand-holding, and a control group with standard care. Infertility and the stress related to assisted reproductive techniques can cause physical and emotional discomfort, and this study explores non-drug methods to help alleviate these issues during IUI procedures. Participants in the Stress Ball Group receive a colored silicone stress ball five minutes before the procedure and are instructed to squeeze it repeatedly during the procedure. In the Hand-Holding Group, the researcher gently holds one of the participant's hands during catheter insertion and removal without interlocking fingers or wearing gloves. The Control Group undergoes the routine IUI procedure without additional interventions. These behavioral interventions are designed to provide comfort and reduce pain and anxiety during the IUI process. Women in the study complete several assessments, including a Personal Information Form, Visual Analog Scale for pain, State Anxiety Inventory, and General Comfort Scale Short Form, both ten minutes before and fifteen minutes after the IUI procedure while being observed. Researchers monitor physiological parameters and collect data to measure the effects of the interventions on pain, anxiety, comfort, and vital signs. The study aims to provide insights into non-pharmacological ways to improve the experience of women undergoing IUI treatment.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

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)
Not Eligible

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

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Research Team

H

Hümeyra TÜLEK DENİZ, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

3

Frequently Asked Questions

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