Effectiveness of stress ball and relaxation exercises on polymerase chain reaction (RRT-PCR) test-induced fear and pain in adolescents in Türkiye.
Vildan Apaydin Cirik, Ayse Sonay Türkmen, Merih Ayaz
https://pubmed.ncbi.nlm.nih.gov/36526480Actively Recruiting
Phase Not Applicable
Age: 18Years - 50Years
FEMALE
ID06759337
The Effect of Stress Ball Used During Intra Uterine 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
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate how holding a patient's hand or using a stress ball during the Intrauterine Insemination (IUI) procedure affects pain, anxiety, comfort, and physiological responses. The study is a randomized controlled trial conducted in the IVF Unit of a Medical Faculty Hospital in Turkey, involving 120 women divided into three groups: stress ball, hand-holding, and control. Infertility and the stress related to assisted reproductive techniques like IUI can negatively impact women's physical and emotional well-being, which this study seeks to address. Participants are assigned to one of three groups. The Stress Ball Group receives a colored silicone stress ball five minutes before the procedure and squeezes it repeatedly during the IUI. In the Hand-Holding Group, the researcher gently holds one of the participant's hands during catheter insertion and removal without additional movement or gloves. The Control Group undergoes the standard IUI procedure without extra intervention. These methods are behavioral and non-pharmacological, aiming to reduce discomfort and anxiety. Women in the study are assessed using several tools before and after the IUI procedure, including a Personal Information Form, Visual Analog Scale for pain, State Anxiety Inventory, and General Comfort Scale Short Form. These assessments occur 10 minutes before and 15 minutes after the procedure while participants are monitored in the patient observation room. The study also monitors physiological parameters and seeks to understand the effects of these interventions on patient comfort and anxiety during IUI treatment.
CONDITIONS
Brief 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
You may qualify if you...
- Agree to participate with verbal and written consent
- Female aged between 18 and 50 years
- Able to read and write in Turkish
- Undergoing Intrauterine Insemination (IUI) as infertility treatment
- For Stress Ball Group: No muscle or joint problems preventing squeezing the stress ball
- For Hand Holding Group: No problem with holding hands
You will not qualify if you...
- Use of any analgesic agent within 24 hours before the procedure
- Having a chronic pain disorder
- Abandoning completion of data collection forms
- Needing urgent physician intervention during or immediately after the procedure
- Having any psychiatric disease
- Having a visual, hearing, speech, physical, or mental disability
- Discomfort with the hand-holding application (Hand Holding Group only)
- Not applying the stress ball use as requested (Stress Ball Group only)
- Wanting to leave the study at any stage during the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single procedure day
Participants undergo the Intrauterine Insemination (IUI) procedure while receiving one of the behavioral interventions: using a stress ball during the procedure, hand-holding by the researcher during catheter insertion and removal, or no additional intervention.
1 procedure visit (in-person)
Post-procedure Observation
Duration - 15 minutes post-procedure
Participants are observed for 15 minutes after the IUI procedure to assess pain, anxiety, comfort, and physiological parameters.
1 observation visit immediately after treatment
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
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