Clinical trial NCT06759337: The Effect of Stress Ball Used During Intra Uterine Insemination on Pain, Anxiety, Comfort and Physiological Parameters
Official title: The Effect of Stress Ball Used During Intra Uterine Insemination on Pain, Anxiety, Comfort and Physiological Parameters: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility Assisted Reproductive Technology
Infertility, Female
Keywords: Assisted Reproductive Techniques
Stress Ball
Pain
Anxiety
Comfort
Physiological Parameters
infertility
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: Infertility is a significant social and health issue, negatively affecting couples, particularly women's biological, physical, and psychosocial well-being. Assisted reproductive techniques are utilized to help couples with infertility achieve parenthood (Taşkın, 2023). Among these techniques, the Intrauterine Insemination (IUI) procedure can lead to pain, anxiety, discomfort, and trauma, both from the procedure itself and from the emotional impact of infertility. Pain associated with trauma and anxiety may trigger adverse effects, such as increased catecholamine levels, reduced heart rate, blood pressure, and lung vital capacity, due to the activation of the sympathetic nervous system (Yıldız Fındık and Soydaş Yeşilyurt, 2017; Vaajoki et al., 2012).

To alleviate acute pain and enhance comfort during IUI procedures, in addition to medical interventions, non-pharmacological methods with minimal side effects are also critical (Stewart and Cox-Davenport, 2015). One such approach is the attention distribution method, which enables brain receptors to shift focus away from painful stimuli, thereby reducing pain perception and improving control (Elmali and Balcı Akpinar, 2017). The use of stress balls as a non-pharmacological method of attention distribution is particularly noteworthy. Stress balls are accessible, cost-effective, and safe. Furthermore, their use offers a holistic approach, incorporating touch, healing, and therapeutic effects (Yanes et al., 2018). A review of the literature reveals various findings on the psychometric and vital sign changes-such as anxiety, stress, comfort, and compliance-associated with stress ball use during medical procedures, including colonoscopy, endoscopy, extracorporeal shock wave lithotripsy (ESWL), prostate biopsy, radiography, hemodialysis, intravenous (IV) procedures, and polymerase chain reaction (PCR) testing (Apaydin Cirik et al., 2023; Çakır and Evirgen, 2023; Özen et al., 2023; Karataş and Gezginci, 2023, 2022; Gezginci et al., 2018a; Karataş and Gezginci, 2018; Quan et al., 2016). Additionally, some studies highlight the therapeutic or healing benefits of touch in children and intensive care settings (Garrett and Riou, 2021). However, the specific effects of hand-holding and stress ball use on pain, anxiety, comfort, and physiological parameters during the IUI procedure have not yet been thoroughly investigated.

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,

Primary outcomes:
measure: Personal Information Form
timeFrame: The researcher will apply 10 minutes before the IUI procedure and 15 minutes after the procedure to women who are kept under observation in the patient monitoring room after the IUI procedure.
measure: Visual Analog Scale
timeFrame: The researcher will apply 10 minutes before the IUI procedure and 15 minutes after the procedure to women who are kept under observation in the patient monitoring room after the IUI procedure.
measure: State Anxiety Inventory
timeFrame: The researcher will apply 10 minutes before the IUI procedure and 15 minutes after the procedure to women who are kept under observation in the patient monitoring room after the IUI procedure.
measure: General Comfort Scale Short Form
timeFrame: The researcher will apply 10 minutes before the IUI procedure and 15 minutes after the procedure to women who are kept under observation in the patient monitoring room after the IUI procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University Medical Faculty Hospital IVF Unit
state: Melikgazi
Study officials:
affiliation: Kafkas University
name: Hümeyra TÜLEK DENİZ, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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